Project Manager

Job position: Project Manager

Qualification: M. Pharm / Pharma D, Life science graduates

Experience: 3-5 years of Project Management experience, Overall - 10-12 years of experience

Location : Ahmedabad

Detailed JD

• Overall Project Management of the assigned projects starting from project initiation till closure of the project.
• Ensure the project delivery as per defined quality standards, Protocol, service agreement, SOPs, GCP and other applicable guidelines.
• Manages multiple projects as assigned by HOD/CBCC Management.
• Coordinate with regulatory consultant/designee for regulatory submission and approval process.
• Coordinate with Sponsors throughout the project cycle for delivery of project as per contract.
• Set up project team in conjunction with HOD and to delegate the activities to study team
• In consultation with HOD, identify the scope of the project that needs to be outsourced to third party and shortlist the potential Vendors for the same from CBCC database, or else coordinate with HOD and QA to identify and qualify new vendors as per project specific requirement
• Site finalization in consultation with HOD & Budget negotiation and finalization of CTA with Site
• Coordinate with Vendors for the setting up the system as per the project specific requirement in a timely manner.
• Develops project plan, including all elements listed in the CBCC project plan template as appropriate for the project (Project milestone and Timelines, Roles and Responsibilities, Communication Plan, Risk Analysis, monitoring plan, Quality Management etc).
• Ensures that study specific management tools, trackers and Trial Master File Maintenance plan are set up before project initiation and maintain throughout the project life cycle.
• Implement the internal quality management program for internal audit for each clinical study assigned. Participate and support project related external audits
• Preparation of project specific training material for SIV and perform Site initiation visits with CRA, for onsite training to site staff. Ensuring adequate study team training including training evaluation.
• Perform the periodic review for the project with study team and update the status of the project to sponsor and management periodically.
• Overall budget management (including review and approval of Site Invoice and Vendor Invoice) for the trial
• Co-Monitoring for training of CRAs (pre-study, initiation & training, routine, and close-out visits)
• Ensure AEs/SAEs management as per the protocol and its reporting to the concerned parties and regulatory, as applicable.
• Maintaining the quality within the study through regular review and if required prepare and implement CAPA in case of any quality issues identified, in consultation with HOD and QA team.
• Identification of quality issues within the study through regular review of the clinical study team communication & documentation.
• Tracks metrics of clinical research projects assigned and provide project metrics, project status reports and other administrative reports to Sponsor and senior management throughout the project.
• Supervises activities of the project CRAs, including the scheduling of monitoring visits, other activities associated with the project (e.g., review of visit reports for completeness and accuracy, assisting monitors with problem sites, etc.), and time accountability for the project.
• Assists and guides CRAs in conducting Pre-Study Visit, Site Initiation & Training Visit, Interim Site Monitoring and Closeout Visits as needed. May also have monitoring responsibilities within the projects as per the requirement.
• Tracks project timelines, milestones and budget requirements for assigned projects
• Reconcile work done against invoices and track out of scope tasks.
• Drafting and development of standard procedures of new department, services, and annual revision of CBCC Standard Procedures.
• Supervise, train, and mentor Clinical Staff and new recruits within CBCC.
• Participate in Clinical research training program as a trainer.
• Support proposal making of clinical trial inquiries, if required.
• Ensures compliance with the Quality Standard requirements of quality management system and relevant documentation and filing.
• To work as per GCP, New Drugs and Clinical Trials Rules 2019, Medical Device Rules 2017, other applicable regulations and to ensure Compliance for the same.
• Any other task assigned by HOD/Designee.