Job Title: Clinical Project Manager

Location: Mumbai, India

Reporting to: Sr. Manager - Clinical Development

Primary Job Function:

Manage all aspects of the assigned studies in the capacity of Clinical Project Manager .

Core Job Responsibilities:

Responsible for development, planning and tracking the conduct of the I & D and Registration studies in compliance with the study budget, the quality standards and timelines. Accountable for ensuring legislation, ICH-GCP guidelines, Abbott EPD SOPs and Indian clinical research SOPs are maintained and followed on all studies.

Supervisory/Management Responsibilities:

Direct Reports: NA

Indirect Reports: NA

Position Accountability/Scope:

- Develop Synopsis, Protocol, Relevant Study Documents in discussion with I and D and also Medical Indian team and Global team.

- Work with Global team for relevant approvals as per processes Develop study management plans, together with team assignments and accountabilities and oversight of database and study maintenance.

- To provide appropriate information for local and central tracking systems within required timelines

- Serve as primary project contact with Stakeholders & vendors 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.

- Maintain appropriate communication with relevant functional areas

- 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.

- Vendor management

- 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 India Limited for activities related to clinical research

- Ensure together with line manager appropriate delegation of study related responsibilities during absence.

Minimum Education:

PhD/ MBBS/MD Pharmacology /Mpharm

Minimum Experience/Training Required :

- Minimum 4-5 years of work exp. in various capacities for clinical research in MNC CRO or MNC Pharmaceutical Company.

- Previous experience of working within the pharmaceutical industry in Drug Development and, in particular, NDDS is preferred, but not mandatory.

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