Clinical Study Manager Salary in India - PayScale

At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.AOD refers to 'Analytics on Demand' and offers a broader selection of functional solutions providing rapid access totop talent, flexibility to move resources across a wide array of levels and geographies, and the ability to draw in greater expertise fromthe wider Cytelservices.Position Summary::Manage operations part for the client delivery team and ensure all operations are met within agreed timelines with quality.:Under the guidance of the Director of Operations perform operations support activities including Employee Onboarding, Training Coordination, Performance appraisal, termination documentation/communication, bench management, immigration, liaising with finance/legal/HR/Immigration to resolve queries/issues, support Engagement Managers with invoice data or any other associate data under minimal supervision.:With support from Director Operations and Engagement Managers manage metrics data generated by deliverable teams and are met to expected quality and timelines.:Mentor/develop employees under the guidance of AD/Dir or designee.:Lead/support data collection activity to help with governance meetings (ex: metrics data to be presented at governance meetings).:Support to improve engagement levels as needed under the Guidance of AD / Dir : OperationsJob Function/Responsibilities::Recognize, demonstrate, and observe Cytel values which center on our commitment to People, Clients and Performance.:Recognize the importance of and create a culture of process improvement with a focus on streamlining current processes adding value to Cytel business and meeting client needs.:Travel both domestic and/or international is required.:Read, understand, and adhere to all assigned Cytel SOPs and working procedures (or sponsor as appropriate).:Identify and organize the training needs as appropriate in coordination with Engagement Managers or designees.:Ensure completion of all assigned training courses, ensuring that mandatory courses are completed before the designated date and that the required system:specific training has been completed for current studies.:Perform interim /annual performance appraisal of assigned team members identify gaps and propose development plans in consultation with Engagement Managers or designees.:Identify gaps and suggest process improvements (internal/external) on an ongoing basis.:Responsible for administrative activities and performing other general duties as required to support the company.:Liaise with the AD/Dir and Sr.Leadership team to ensure that overall project objectives are met in an efficient manner.:Provide input to the development of new systems and processes, as required.:Under the guidance of Director Operations/EMs, ensure adequate processes are put in place in response to deviations in data quality, timelines, and/or budget.:Provide regular feedback to the delivery team members on their performance and initiate follow:up reviews where required (work with Group TA heads on performance concerns, mitigation plans, and expected improvement; awarding/sending accolades with appropriate follow:ups and confirmation).Mandatory Experience/Skills/Knowledge Requirements:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions;:10:12 years of appropriate experience in a similar role;:A minimum of 5

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 Project Manager (CDC Trial Manager) for the Clinical Medical Regulatory team based at Mumbai. If you have what it takes to be a part of Novo Nordisk team, Apply nowThe positionAs a CDC Trial Manager is the main accountable person in making sure that deliverables are met as per project timelines, within budget and complying with Protocol, country regulatory requirements, Helsinki Declaration, GCP (Good Clinical Practice) and NN SOPs (Standard Operating Procedures). Key responsibilities include: : :Driving assigned clinical trial from the feasibility to Clinical trial reporting.:The activities include planning, site selection, Ethics committee and health authority submissions, starting:up trial sites, organize investigator meetings.:Training Site staff, CRAs, CTAs, start:up teams about the protocol and other protocol related information, providing operational and therapeutic expertise to the CDC project team, achieve deliverables within agreed timelines and in accordance with scientific, quality, and regulatory requirements.:To ensure effective communication of all trial/project related issues between HQ, CDC, the region, and other Internal/external stakeholders.:Responsible for representing CDC countries in relevant study meetings and organize these meetings: Trial Squad Meetings Monitor meetings, Investigator meetings, Study Result meetings.QualificationsTo be successful in this role, you should have the following qualifications::You should have a bachelor's degree in life science, pharmacy, or nursing qualification or equivalent.:You should have least 5+ years of experience in clinical monitoring.:Basic GCP qualification and high level of understanding of GCP requirements.:You must have advanced level knowledge of Excel and PowerPoint presentation. :Good working knowledge of electronic clinical trials systems : IMPACT, EDC, IWRS, electronic TMF (Trial Master File).:Good Communication and should be able to collaborate with internal and external stakeholders.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 Project Manager (CDC Trial Manager) reports directly to the Clinical Operations Manager (COM) and demands responsibility to recruit and develop the CRAs to achieve the project deliverables and implement necessary actions to support and improve their performance. Co:monitoring visits with the CRA and, in partnership with the COM, monitor the quality of the clinical trial execution, quality audits and inspection issues. 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. Identify new sites, coordinate site assessments (if required) and elect appropriate sites to allocate local clinical trials liaising with the COM and Head.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 than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in

Department :Centralised Monitoring Unit (CMU)Does 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 are actively involved in Risk:based medical monitoring in collaboration with the medical specialists from Denmark, with a 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 require medical attention and medical data cleaning. The Functional Programmers develop operational visualizations in data visualization tools to support the trial teams on proactive centralized monitoring and Statistical Monitors perform the 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 a Medical Review of all trial subjects of all assigned clinical trials within the drug development portfolio across therapy areas and to ensure high:quality 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 Procedures (SOPs). Senior 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 the status of the medical review to the 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. Perform the quality check measure for the 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 Specialists to enable decision:making. Responsible for documenting medical reviews 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. Provide training on the project and process to the new team members.: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).:2:3 years of experience as a Medical Reviewer is preferred.:1:2 years of experience in project management is required.:Good knowledge of ICH (International Council for Ha