Once the protocol is approved by the investigator and dossiers for the study are submitted to the Regulatory and Ethics committee project is handed over to Project Manager.
- Acts as the primary point-of-contact and liaison with the Sponsor to provide outstanding clinical project management and customer service with my excellent PR and interpersonal skills.
- Lead clinical project management teams, and organise clinical study meetings and presentations, including Sponsor meetings and teleconferences, and Clinical Project Management Team Meetings.
- Actively participates in Designing and developing clinical trial documents such as Study Plans, Site Manuals, and Subject Information/Consent in close association with technical teams.
- Prepares and/or reviews protocols and other study documentation as required by the Sponsor and in collaboration with the Technical departments.
- Designs and develops the Case Report Form with the help of technical team.
- Oversees submissions to authorities and IEC/IRB submissions (in collaboration with the Technical/Medical Writing department) including overseeing collection of essential documents from sites and Sponsor, organising translations of study related documentation.
- Act as a control over line managers for assigned clinical research staff.
Operations team which is the integral part of the Project Team:
– Has responsibility for coordinating the planning, development, and implementation of clinical protocol, administrative and logistical procedures, documentation, and operating systems.
– Supervise, evaluate and coordinate the activities of a study team, to ensure that all clinical activities are carried out in accordance with established SOP
– Establish and track project related timelines and contribute to project development and delivery as assigned.
– Define, review and approve project tracking tools, training requirements & budgets and ensure timely finalization of study documents & take appropriate corrective actions in case of deviations.
– Pplan and carry out programs for the recruitment, screening, enrollment, and retention of clinical research subjects and/or volunteers.
– Prepare structure of project specific communication plan including an escalation process for fraud, misconduct, SAEs etc.
– Co-ordinate regulatory process (e.g. Submission, Approval, requisite licences for import/ export of study drug or laboratory samples or any project specific equipment etc).
– Prepare and coordinate Confidentiality Agreements, Clinical Study Agreements and negotiate changes or modifications to these documents with Investigators & sponsors.
– Ensure that ongoing status reports are sent to the sponsor within requested time frame with appropriate backup data
– Review and approve monitoring reports and other site master file & trial master file documents.
– Responsible for coordination & planning the conduct of Investigator meeting
– Prepare all study sites for internal, Sponsor audits and/or Regulatory inspections.
Project Management Team in general
– Assesses operational, financial, and materials requirements for the study and prepares operating budgets, plan and coordinate the procurement of required clinical facilities, equipment and supplies.
– Coordinate protocol requirements with outside agencies and select vendors as per the scope of the project.
– Oversee the planning, scheduling and carrying out of day-to-day activities of the study team.
– Represent and promote the objectives and activities of research studies to various internal and/or external stakeholders, as necessary.
– Assist the Clinical operations head in forming project specific study teams by proper allocation of resources depending on the defined roles and responsibilities and providing an assessment of the workload.
– Assist the Business Development head in identifying & creating a database of investigators & study sites for different therapeutic areas.
– Assist the Business Development team in business development activities like attending industry seminars & conferences, preparing presentations to be given to prospective clients.
– Participate in and contributes to personnel training seminars. Ensures appropriate trainings, including project specific trainings are done as required within specified timelines.
– Maintain current knowledge of company standard operating procedure (SOP) and participate in annual review of all SOPs