Table of contents
Core Job Responsibilities
Clinical Project Lead
Responsible for planning and tracking the conduct of the study in compliance with the study budget, the quality standards and timelines. Accountable for ensuring legislation, ICH-GCP guidelines, Abbott GPRD and Indian clinical research SOPs are maintained and followed on all studies. Clinical trial oversight, vendor oversight/management; stakeholder management within Abbott, coordination with Regulatory team for DCG (I) submissions, CTRI updates etc.
Direct Reports: NA
Indirect Reports: NA
Responsible to create an effective project strategy, build an airtight project plan, and drive daily activities while problem-solving along the way to achieve the project delivery as per the scope and timelines agreed
Responsible for complete oversight of the project and also able to manage multiple deliverables (mutli-tasking) and prioritise in a manner that the final deliverables are not affected
Proactively escalates risk which impacts budget, overall project timelines and/or affects quality to supervisor along with suggestive resolution/actions in a timely manner and implement and ongoing risk management / mitigation during the project life cycle
Responsible for Identifying gaps, implement changes in process/product improvements that benefit the organization (w.r.t cost / timelines / quality).
Develop study management plans, together with team assignments and accountabilities and oversight of database and study maintenance. Ensures all project tracker up to date with recent information (finance, resource utilization, oversight, enrolment, site list, essential documents, site activation)
Responsible to identify, collect and structure the available data/hurdles impacting the project and implement course corrections in timely manner. Conducts scenario analysis & acts on the most appropriate scenario (in discussion with the manager)
Responsible for stakeholders management (internal and external) and is able to gains support for ideas, proposals and/or projects by negotiating & influencing relevant stakeholders.
Understanding of the larger business context and to collaborate effectively with various cross functional teams to lead and ensure completion work/project delivery in a timely manner.
Serve as primary project contact with vendors and internal stakeholders to ensure communication is maintained and reporting and tracking schedules are adhered to through study execution phase.
Manage and co-ordinate with cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure compliance with standard processes, policies and procedures.
Ensure the safety reporting requirements & reviews for the associated projects as per PV SOPs & Process.
To anticipate and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action as indicated. Use functional expertise and exercise good judgment in seeking appropriate guidance and ensure that follow-up to any and all corrective action is taken at the clinical site and is properly documented
Undergo and maintain training as required by the functional role and other relevant company procedures, to ensure adherence to ICH-GCP, Abbott SOPs, processes and procedures, local Work Instructions (if any), applicable regulatory requirements and study specific needs
Provide input for the development of proposals and study documents for clinical studies and manage project budgets.
Contribute to achieving satisfactory study audits internal and external
Forecasting budget for assigned studies and keeping a track on planned actual expenditure for assigned studies to ensure the study budgets are on track.
Maintain at most quality for study related documents and all the clinical trial activities performed
Forecasting study milestones of assigned clinical trials and accomplishing deliverables as per the planned milestones
Mentoring juniors and interns (if any) at Abbott for activities related to clinical research
Ensure together with line manager appropriate delegation of study related responsibilities during absence.
M. Pharm/ B. Pharm/MSc/BSc with PGDCR/ Medical, pharmacy or life-sciences degree (or equivalent)
Minimum Experience/Training Required
Minimum 13 years of work exp in clinical research. 2 to 3 year experience in as Project Lead / Project manager. Experience in MNC CRO or MNC Pharmaceutical Company preferred.
Previous experience of working on various phases of clinical trials which includes interventional and non-interventional trials.
- Hospital & Health Care
- Information Technology