Table of Contents

Project Management

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.

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

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