Clinical Trial Manager Salary in India - PayScale

Job Title:Lead Data Facilitation ProgrammerDepartment :CDS GBSAre you passionate about quality and simplification? Do you want to build quality within processes in the most efficient way? Do you have an innovative mindset to drive change in a future:ready environment and support your colleagues and stakeholders by challenging the status:quo in a friendly and open:minded way? If so, there is a job opportunity waiting for you as our new Lead Data Facilitation Programmer. At Novo Nordisk, we will challenge you to do the best work of your life. Apply Now.The PositionAs the Lead Data Facilitation Programmer of Data Management and Centralized Data Review at Novo Nordisk, you will be responsible for driving and execution of Health Tracker, EDC and Audit Trail Reports and also any future reports requested by the team at required frequencies. Ensure Data Visualization facilitate visualizations to stakeholders for data review. Perform mapping, testing, creating conversions and supporting the DBL activities across interfaces. In addition setting high goals for personal and group accomplishment, tenaciously working to meet or exceed goals.Programming on Python, R and Power BI with exposure to Clinical Data Management would be added advantage.The Lead Data Facilitation Programmer key responsibilities :stylemargin:bottom:8.0px::Ensure Reports execution of Health Tracker, EDC and Audit Trail Reports at required frequencies. Perform programming, review and update of relevant documents pertaining to reports creation. Facilitate Audit Trail Report in accordance with Risk:Based Data Management Guidelines.:Data Visualisation: Design, build, and maintain interactive dashboards for real:time clinical data monitoring and analysis for data review using Python or R. Cater to the trial specific requirements on visualization to stakeholders. Design, develop and maintain data visualization dashboards to help users understand and analyse data.:Data integration: Develop and manage robust data systems that consolidate data from various sources, including EDC systems, clinical databases, and third:party platforms. Implement data pipelines for efficient data flow and processing, ensuring data integrity and timeliness.:Collaboration: Work closely with clinical data managers, clinical data facilitators, and IT specialists to define requirements and deliver data solutions. Communicate complex data concepts and insights effectively to non:technical team members and stakeholders. :Code management: Maintain clean and well:documented codebases. Use version control systems like Git to manage code changes and collaborate with other team members. Use Agile framework for prioritizing and implementing projects.Implement security measures to protect sensitive clinical data. Maintain patient confidentiality in accordance with HIPAA and other privacy regulations.Qualifications::Masters / Bachelor's degree in Life Science or comparable degree in computer science, Information Technology clinical information management or equivalent qualifications.:Minimum 5:8 years of experience in pharmaceutical industry with programming background and preferably 2 years within clinical data management systems:Understanding of protocol, CRF standards, Inform Terminologies and EDC data structure:Knowledge and experience in Programming languages such as Python, R and Rshiny:Knowledge and experience in data visualization tools like Tableau or Power BI:Knowledge of computer systems, IT and clinical data process flow:Knowledge of clinical development and basic medical terminology:Experience in project management, collaboration, communication and presentations skills.:Profound Knowledge of GxP and guidelines within drug development.About the Department:Our Data Management group is 350+ professionals spanning across India, Denmark and N

Department : Clinical Medical Regulatory (CMR)Do you want to be a part of a high performing team in Novo Nordisk that plays a critical role in driving the success of the business? Do you have what it takes: the right drive, a sharp mind, customer orientation, openness and focus on what matters and a genuine interest in working with people? If you find challenges inspiring and want to drive innovation within a multifaceted and inspiring working environment, you may be our new CRA Manager for the Clinical Medical Regulatory team based at Bangalore. If you have what it takes to be a part of Novo Nordisk team, Apply nowThe positionThis role requires someone to Coordinate, in partnership with the COM (Clinical Operation Manager) and CDC:TM (Trial Managers), the clinical trial set:up at a local level to ensure appropriate site and resources allocation. Manage local clinical projects, ensuring they are executed in a timely and effective manner, within budget and complying with regulatory requirements, Helsinki Declaration, GCP (Good Clinical Practice) and NN SOPs (Standard Operating Procedures). Provide clinical trial related communication and insight to internal and external stakeholders. Manage and coach CRAs (Clinical Research Associate). As a CRA Manager you will be responsible to::Recruit and Develop CRAs and implement necessary actions to improve their performance.:Lead quality clinical trial projects (CDP and/or local) in the country.:Provide trial related communication and insight to key internal and external stakeholders.:Coordinate the clinical trial set:up in partnership with the COM.:Maintain ongoing communication with Ethics Committees and the Health Authority, ensuring the Central and local (as applicable) Ethic Committee is provided with the documents requested.QualificationsTo be successful in this role, you should have the following qualifications::8 to 10 years of experience in managing global clinical trials as CRA/Sr. CRA (approx. 6 yrs) and Team lead/Trial Manager (aprox. 2 yrs):Currently leading/managing project team of CRAs and or CTAs:Candidates with prior experience in handling Diabetes/Obesity/OSCD (Other Serious Chronic Diseases)/Hemophilia/Growth Hormone disorders trials will be preferred:Experience in managing clinical trials from study start:up to study closeouts':Must be willing to travel approx. 10 days/month:Graduate or Post Graduate in Pharmacy or Lifesciences or other related fieldsAbout the departmentThe Novo Nordisk India affiliate office is located in Bangalore and has more than 1400 people working across the country in various functions. Our Marketing Department is a dynamic, creative, and collaborative team committed to data:driven strategies, customer:centric design, innovative digital practices, and delivering measurable results. As part of our department, you'll have the opportunity to contribute to diverse projects, continually grow your skills, and directly impact our company's growth trajectory.Working at Novo NordiskAt Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas

Department :Centralised Monitoring Unit (CMU): BangaloreDoes your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can:do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment.About the departmentThe Centralised Monitoring Unit (CMU): Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers actively involved in Risk based medical monitoring in collaboration with the medical specialists from Denmark, with focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that requires medical attention and medical data cleaning. The Functional Programmers develop operational visualisations in data visualization tools to support the trial teams on proactive centralised monitoring and Statistical Monitors perform detection of unusual data patterns, systematic errors and potential lack of compliance or fraud across trials.Job Level: 6The Position:(Note: This is not a role within Pharmacovigilance)The Key Responsibilities in this position will be to perform Medical Review of all trial subjects of all assigned clinical trials within drug development portfolio across therapy areas and to ensure high quality consistent medical data. Medical Review is performed for all trial subjects to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, local regulations, and Standard Operating Procedure (SOPs). Medical Reviewer ensures high quality medical data through medical review of clinical trial data. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s) and Medical Specialists during trial conduct. Report status of medical review to project as appropriate, following the project communication plan and blinding plan. Consult with Trial Managers and Medical Specialists as appropriate to ensure medical review issues are escalated in a timely manner.:Responsible for contribution to or participation in trial planning activities related to medical review.:Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites.:Responsible for presenting findings of Medical Review to relevant Medical Specialist to enable decision making. Responsible for documenting medical review in the sponsor TMF.:Ensure close collaboration with relevant study group members, especially the Data Manager , Trial Manager(s) and Medical Specialist during trial conduct.:Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review.Qualifications::Minimum as Graduate in Medicine or other relevant (MBBS and MD in pharmacology preferred, MBBS and MD in other clinical/paraclinical areas with relevant experience in clinical patient management/ clinical research).:2 + years of experience as Medical Reviewer is preferred.:Good knowledge of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), GCP (Good clinical Practice).:Demonstrated computer skills (MS Office, MS Project, PowerPoint).:Excellent understanding of medical termin

Department :Centralised Monitoring Unit (CMU): BangaloreDoes your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can:do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment.About the departmentThe Centralised Monitoring Unit (CMU): Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers actively involved in Risk based medical monitoring in collaboration with the medical specialists from Denmark, with focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that requires medical attention and medical data cleaning. The Functional Programmers develop operational visualisations in data visualization tools to support the trial teams on proactive centralised monitoring and Statistical Monitors perform detection of unusual data patterns, systematic errors and potential lack of compliance or fraud across trials.The Position: (Note: This is not a role within Pharmacovigilance) The Key Responsibilities in this position will be to perform Medical Review of all trial subjects of all assigned clinical trials within drug development portfolio across therapy areas and to ensure high quality consistent medical data. Medical Review is performed for all trial subjects to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, local regulations, and Standard Operating Procedure (SOPs). Medical Reviewer ensures high quality medical data through medical review of clinical trial data. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s) and Medical Specialists during trial conduct. Report status of medical review to project as appropriate, following the project communication plan and blinding plan. Consult with Trial Managers and Medical Specialists as appropriate to ensure medical review issues are escalated in a timely manner.:Responsible for contribution to or participation in trial planning activities related to medical review.:Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites.:Responsible for presenting findings of Medical Review to relevant Medical Specialist to enable decision making. Responsible for documenting medical review in the sponsor TMF.:Ensure close collaboration with relevant study group members, especially the Data Manager , Trial Manager(s) and Medical Specialist during trial conduct.:Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review. Qualifications::Minimum as Graduate in Medicine or other relevant (MBBS and MD in pharmacology preferred, MBBS and MD in other clinical/paraclinical areas with relevant experience in clinical patient management/ clinical research).:2 + years of experience as Medical Reviewer is preferred.:Good knowledge of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), GCP (Good clinical Practice).:Demonstrated computer skills (MS Office, MS Project, PowerPoint).:Excellent understanding of medical

Department: Global Medical Affairs : (Regions and Operations).Are you passionate to be innovative and creative to ensure a competitive profile of clinical operations management, driving engagement and education among healthcare professionals and patients? Do you have new ideas and solutions that can be developed to further advance clinical trials? We are looking for a Scientific Strategic Advisor to join our Global Medical Affairs team in Bangalore. If you are ready to make a difference and contribute to our mission of improving patient lives, read on and apply today for a life:changing career.About the departmentThe Global Medical Affairs team in Bangalore is an extension of the Global Medical Affairs department headquartered in Denmark. We work closely with the regional CMR departments and the Medical Affairs department in the US affiliate of the company. Our team consists of highly motivated global medical advisors, global scientific advisors (medical writers), project managers, graphic designers, and publication managers. We are dedicated to communicating scientific and medical knowledge on our products to the external scientific community and across the organization.The PositionThe position holder will assist closely in providing medical/scientific guidance and strategic inputs covering a portfolio of products for clinical operation across trials. He/she will execute the below tasks demonstrating Subject Matter Expert status::Collaborate with cross:functional teams to develop and refine clinical trial strategies, ensuring alignment with scientific objectives and business goals.:Provide scientific leadership and guidance throughout the lifecycle of clinical trials, including protocol development, study design, and scientific review of study:related documents.:Contribute scientific insights to the selection of investigational sites, study endpoints, and the evaluation of scientific data, supporting the development of clinical trial protocols.:Identify potential scientific and operational risks within clinical trials and develop proactive strategies to mitigate these risks, ensuring the scientific integrity of the studies.:Stay abreast of relevant regulations, guidelines, and industry best practices, providing scientific input to ensure compliance with regulatory requirements in clinical trial conduct.:Collaborate with cross:functional teams to interpret scientific data, ensuring accurate and meaningful presentation of clinical trial results.:Coordinate early trial feasibility input.:Organize recurrent insights sharing within and from the clinical medical manager (CMM) network.:Identify early TA trends and plan solicited insights among CMMs.:Identify common trial challenges and suggest CMM intervention points.Qualificationsstylelist:style:type:circle;margin:bottom:11.0px::Should possess Bachelor's/Advanced degree in a scientific discipline (e.g., MD, PhD, PharmD, MDS).:Should possess at least 2+ years of clinical and/or pharmaceutical industry experience.:A strong understanding of clinical research and drug development processes.:Demonstrated research experience (e.g. publications).:Proven experience in clinical operations, clinical trial management, or related roles within the pharmaceutical, biotechnology, or clinical research industry.:Strong understanding of regulatory requirements and guidelines governing clinical research.:Excellent communication and presentation skills, with the ability to effectively translate complex scientific concepts for diverse audiences.Working at Novo NordiskNovo Nordisk is a leading global healthcare company with a 100:year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more t

Department : CDD GBSAre you passionate about quality and simplification? Do you want to build quality within processes in the most efficient way? Do you have an innovative mindset to drive change in a future:ready environment and support your colleagues and stakeholders by challenging the status:quo in a friendly and open:minded way? If so, there is a job opportunity waiting for you as our new Department Coordinator. At Novo Nordisk, we will challenge you to do the best work of your life. Apply Now.The PositionAs a Department and coordinator, you will be responsible for performing administrative tasks, ensuring successful collaboration with other department coordinators, managers, and teams, providing support to the management team within CDD GBS, designing and preparing content for communication, presentation, analytics, and other purposes, and supporting and contributing to events, initiatives, and other organizational activities. Additional responsibilities include administrative Task , Calendar Management, Stake Holder, Vendor Mgmt, Procurement, Invoicing (PO), Logistics, Document Mgmt, Personal Assist . The ideal candidate will have excellent communication and interpersonal skills, as well as experience working in a fast:paced environment. stylemargin:bottom:11.0px::As a Department Coordinator, an ideal candidate is responsible for Organizing meetings, preparing presentations, coordinating events, maintaining IT assets, and drafting org. chart presentations to support the department.:Responsible for Collection of data, preparing and publishing reports, and coordination with stakeholders to track status for data collection within the unit, Creating BNQ/PO, use relevant systems, and represent the department for queries from vendors/procurement/finance departments for finance and procurement.:Managing access, Teams folder and data management, and periodically review Teams channel for MS Teams management.:Managing the department heads calendar, maintain and publish the annual department meeting calendar, coordinate meetings, participate in department meetings, and prepare agendas when required to support department management.:Contributing to planning and management, ensuring deliverables are met, prepare Mom's and track action points, and perform quality checks to provide support. Ensuring compliance with business ethics policies and procedure.Qualifications:stylemargin:bottom:4.0px::Graduate degree, Post Graduate degree. 2:4 years of relevant experience in a role involving co ordination and support activities:Ability to understand the stakeholder's perspective and present the same in the form of graphics/visual (via MS PowerPoint) :Awareness of presentation design skills (i.e. dynamic charts and diagrams) and clean design aesthetic presentations:Awareness in MS office, Photoshop, Illustrator, Flash and/or Webpages Extensive experience with programming in e.g. SAS or R.:Microsoft office expertise, Share point and presentation skills. Ability to collaborate and communicate across various stakeholders.:Ability to represent NN in relation with users and external stakeholders. Excellent communication skills (written and oral : English).About the Department: The Centralised Monitoring Unit (CMU): Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers actively involved in Risk based medical monitoring in collaboration with the medical specialists from Denmark, with focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that requ

Location: Delhi/Mumbai/HyderabadBusiness Unit: CMR (Clinical, Medical, Regulatory and Pharmacovigilance)Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future:ready environment? Are you best at what you do? If so, 'Raise your hand' as there is an exciting opportunity waiting for you as a Clinical Medical Manager with us.At Novo Nordisk, we assure you will experience the best.The positionAs Clinical Medical Manager, you will facilitate execution of clinical trials related to New Therapy Areas (including CVD, CKD, NASH) by providing medical/scientific expertise and advice based on interactions with KOLs, independent professional associations and patient advocacy associations as necessary. You will be responsible for::Identify KOLs, investigators and research centres: Identify and map KOLs, investigators and research centres within the relevant therapy areas and collaborate closely with clinical operations teams in HQ, IO:SO and CDC during feasibility and allocation process.:Collect early scientific insights and guidance: Discuss relevant early development data with external medical and scientific experts optimizing the feasibility process for the clinical trial conduct and provide leadership in the scientific community within New Therapy Areas conducting advisory boards, scientific meetings, engaging with local associations for HCPs on relevant topics.:Contribute to Clinical activities: Contribute to delivering successful clinical trials (phase I:IV) in collaboration with clinical operations including driving scientific discussions at site selection and initiation visits, performing ad hoc visits, supporting attendance at investigator meetings, ensuring KOL inclusion in clinical trials, and engaging key investigators to communicate trial results.:Deliver Medical guidance: Provide timely guidance and internal training by supporting training creation and delivering training to clinical staff.:Scientific Communication: Position requires extensive scientific communication internally as well as externally and excellent and proactive communications skills are a necessity. As a Clinical Medical Manager, strong presentation skills are a must.Qualifications:MBBS/MD with strong clinical research/medical affairs background.:3+ years of clinical or pharmaceutical industry experience with strong experience in human healthcare research either from university, CROs or pharmaceutical industry.:Expert in therapeutic area of relevance (CVD, CKD, NASH), preferably with authorship in peer:reviewed journals and understanding the specificities and nuances of the local healthcare infrastructure.:Understanding of pharmaceutical drug development. :Experience as clinical trial investigator or sub:investigator is preferred.:Open to domestic and international travel in connection with site visits, congresses and company events.About the departmentNovo Nordisk India affiliate office is in Bangalore and has more than 1,600 people working across the country in various functions. Clinical Medical Manager position will be based in metro cities and report to CMM Lead.Working at Novo NordiskAt Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundr

The Senior Statistical Programmer will work directly with the stakeholders to lead and contribute to statistical programming projects and to ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements. The Senior Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets and will ensure audit readiness for all tasks. They will provide mentoring and training to statistical programming staff members and may lead or contribute to the design of new statistical programming processes or optimization of existing ones.JOB RESPONSIBILITIES: :Lead statistical programming activities for assigned projects, which will include projects expected to be submitted to regulatory authorities and may include pooling projects (ISS/ISE). :Co:ordinate activities of all programmers assigned to the project, ensuring high quality, respecting project timelines and adherence to the budget. :Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of project requirements, scope of work and timelines.:Provide relevant training and mentorship to staff and project teams on SAS techniques and clinical trial data with respect to CDISC standards and other regulatory requirements.:Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. :Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance: :clinical study reporting, e.g. ICH E3,:electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation : Part 11, :electronic submission of clinical data to agencies, e.g. e:CTD guidance and CDISC SDTM and ADaM standards.:Understand and follow all relevant standard operating procedures (SOPs).:Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation. :Maintain up:to:date knowledge of programming software (e.g. SAS, R, Python) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.:Occasionally, lead, or contribute to, the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to reach the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness.QUALIFICATIONS: Education: BSc or equivalent with research experience, and/or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics). Master's Degree preferred.Experience: :6 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with good knowledge of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines.:Experience as a lead statistical programmer working with global cross functional teams is required.Skills: :Fluent in English,:Proficient in SAS,:Project management, organizational skills, ability to manage competing priorities, and flexibility to change.:Good understanding of drug development process, including knowledge of interfaces and interdependencies with other functions.:Good time management and interpersonal skills,:Written/verbal communication and presentation skills are needed along with the ability to establish and maintain effective working relationships with coworkers, managers and clients.LI:PJ1

Department: Clinical Medical Regulatory (CMR)Do you want to be a part of a high:performing team in Novo Nordisk that plays a critical role in driving the success of the business? Do you have what it takes: the right drive, a sharp mind, customer orientation, openness and focus on what matters, and a genuine interest in working with people? If you find challenges inspiring and want to drive innovation within a multifaceted and inspiring working environment, you may be our new Clinical Operations Manager for the Clinical Medical Regulatory team based in Bangalore. If you have what it takes to be a part of the Novo Nordisk team, Apply nowThe PositionAs a Clinical Operations Manager you will be Responsible for Project planning and people management for assigned clinical trials for the CDC in the respective therapy area (TA), and ensuring deliverables are met as per project timelines, within budget, and complying with protocol, regulatory requirements, Helsinki Declaration, GCP (Good Clinical Practice) and NN SOPs (Standard Operating Procedures). Manage and coach Project Managers, CRAs, and CTAs. Provide direction and accountability for the operational teams and their delivery. Key responsibilities include: : stylemargin:bottom:2.0px::Lead quality clinical trial projects in the CDC (60).:Provide trial:related communication and insight to key internal and external stakeholders (20).:Develop team members and implement necessary actions to improve their performance (20).:Extensive and proactive communication both internally and externally is essential for the successful implementation of main accountabilities.:The position requires effective people management to develop and lead the therapeutic area.Qualifications :You should have a graduate Degree or higher qualifications in Medical, Pharmacy, Life Sciences, or other related field.:At lead 12:15 Years of experience.:Experience working in therapies like haemophilia, oncology, and growth hormone disorders, rare diseases.:to understand ICH:GCP, local requirements, and Novo Nordisk SOPs.About the departmentNovo Nordisk is a Denmark:based multinational with leadership in diabetes. Novo Nordisk India affiliate office is in Bangalore and has more than 1,400 people working across the country in various functions. The position of Clinical Operations Manager (COM) reports directly to the Head : OSCD, CDC India, and demandsresponsibility to recruit and develop the CRAs to achieve the project deliverables and implement necessary actions to support and improve their performance. This role also requires managing and coaching Project Managers, CRAs, and CTAs. Provide direction and accountability for the operational teams and their delivery. Working at Novo NordiskAt Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life:saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.ContactTo submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructio

Job Description Job Purpose: Reporting to the Medical Director, the Sr. Medical Manager, Medical Affairs is responsible for leading medical strategy and activities for Neuropsychiatry, other therapeutic areas may be assigned as needed. Responsibilities:Co-create medical strategy in assigned therapeutic area(s), with focus on field strategy, and implement medical tactical plans in alignment with cross functional partners (e.g. Sales and Marketing Managers) and Medical Director Accountable for overall KME engagement planning in assigned therapeutic area(s) and field engagement metrics (qualitative, quantitative); monitoring and reporting; sharing medical insights above country (regional or global level)Assist in overseeing the MSL Team in cultivating current and future Key Medical Experts (KMEs) in academic and clinical medicine at the local, regional, and national levels in therapeutic area Accountable for congress strategy at scientific meetings (e.g. KME engagement, unsolicited HCP sponsorship requests, etc.)Facilitate medical information request process (Medical Information), patient support program (PSP) and patient advocacy groups Collaborate with Global Clinical Operations and CCL on early phase trials in the pipeline, phase III, and later phase IV activities (including site and PI lead selection)Partner and collaborate with Market Access, Regulatory Affairs, and Patient Services to show potential medical value of compounds in development to relevant to local external stakeholders (e.g. payers, HCPs, agencies)Develop and manage budget(s) for therapeutic areas medical activities, provide input into the affiliate budgeting and planning process; track and adjust performance against plan Facilitate sharing of best practices and knowledge across therapeutic area(s)Support medical review country-specific materials to ensure scientific accuracy when needed and clearly express rationale for any objection and sign-off before releaseServe as back up for the Medical Director or Associate Medical Director, including at key leadership meetings and for materials review or certification, as requiredParticipate and support regular MSL team meetings (affiliate level); represent affiliate, where required, at TA-specific meetingsPerform company business in compliance with relevant regulations, company policies and proceduresOther duties as assigned Qualifications Education:Advanced degree in a related scientific field, such as MSc (or equivalent) as a minimum, PhD or MD Experience, including # of years:Minimum 7+ years' experience within a medical affairs role in the pharmaceutical or biotechnology industry Experience in a field-based role (e.g. MSL) is considered an assetExperience in neurology, rare diseases or neuromuscular diseases is considered an assetExperience in interaction with health authorities is considered an asset Skills:Ability to convey complex scientific concepts and information tailored to the audience e.g. Key Medical Experts, affiliate staff and regional/global Medical Affairs leadership Ability to work across multiple digital platforms and early adoption of new systems/applications.Excellent knowledge of Regulatory Affairs, Drug Safety, Legal and Compliance environment and requirementsKnowledge and understanding of disease area, local health care system, market dynamics, regulations, policies and SOPs, health economic techniques and trendsDemonstrated strategic approach to implementation of scientific communication programs on disease areas and treatments Has demonstrated leadership skills and acquired knowledge and skills/competencies to the degree expected at job levelLanguage(s):Fluent in English, both verbal and written with the ability to communicate effectively cross functionally, spanning all levels of the organizationProficiency in French an assetAdditional requirements:Ability to travel as needed up to 30-40% of the time Additional Information Why Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I effortsSalary: . Date posted: 04/17/2024 10:14 AM