Prime Responsibilities of A Project Manager in Clinical Trials

A project manager is the person responsible for successfully overseeing a project from start to finish. The job responsibilities of a project manager can range from planning the project, to creating a schedule and timeline, to executing each phase, to managing the budget, to serving as the liaison among all stakeholders, to troubleshooting and maintenance. As such, a project manager must be highly organized and detail-oriented, as well as possess excellent people skills—after all, he or she is responsible for leading the team and communicating clearly and regularly with all relevant parties.

For a project to be successful, it requires a complete team effort. The roles and responsibilities assigned to the team members could be small or huge. But, at the end of the day, every role and responsibility matters as it’s a collective team effort. It is this effort that drives project on the success path. Project manager and project management team are like two facets of a coin.

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The tasks that a project manager is responsible for typically include:

  • Proactively manage project level operational aspects of Clinical Trial Team (CTT) including management  of trial timeline, budget, resources and vendors.
  • Provide efficient updates on trial progress to the Clinical Program Director (CPD) and/or Senior Director of Clinical Operations (DCO), with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
  • Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
  • Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements. 
  • Ensure potential study risks are escalated to the attention of the CDP when appropriate.
  • Chair CTT working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.
  • Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
  • Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
  • Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner
  • Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
  • Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures.
  •  Effectively provide support to Clinical Site Manager(s) in the conduct of the trials.
  • Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts
  • Assesses the operational feasibility of studies and recommends execution and risk mitigation plans
  • Co-monitors as needed
  • Develops and tracks study timelines, budget, and quality metrics
  • Ensures appropriate clinical resources are available for the clinical project
  • Ensures GCP and regulatory compliance is maintained
  • Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
  • Maintains professional expertise through familiarity with therapeutic area and clinical research literature
  • Manages clinical projects from concept through clinical study report completion
  • Oversees clinical research study conduct
  • Manages, mentors, and develops direct reports
  • Organizes and leads the clinical project team.  Leads regularly scheduled cross-functional study team meetings with internal and external resources
  • Participates in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts
  • Participates in meetings with investigative sites, key opinion leaders and consultants as needed
  • Plays a part in the analysis, summary, and reporting of clinical data through the course of the study
  • Aides in the training and development of all clinical staff members
  • Performs other duties as assigned
  • Proactively identifies and resolves issues, and participates in process improvement initiatives as required
  • Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants
  • Reviews and approves invoices from study vendors, investigators, consultants, etc.
  • Evaluates monitoring reports with significant findings to confirm appropriate conclusions and actions taken
  • Reviews serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks
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Core Competencies

  • Critical thinking and problem solving
  • Excellent decision-making and leadership capabilities
  • Contract negotiation
  • Conflict resolution experience
  • Adaptability
  • Able to tolerate stress
  • Enjoy working with people.
  • Strong team player.
  • Great organisational skills.
  • Self-motivated with ability to demonstrate a high level of initiative.
  • Honest and reliable.
  • Positive outlook on life.
  • Can work under pressure and to tight deadlines.
  • Quick to learn and a good attention to details.

Extra Skills

In addition, to relevant experience in Clinical Project Management, you will need to show evidence of the following:

  • Excellent interpersonal skills.
  • Exceptional written and oral communication skills.
  • Experience with MS Project, or similar, would be an advantage. 
  • Ability to work on your own initiative and provide accurate summaries and reports to leadership.
  • Flexibility and adaptability to juggle a range of different tasks and to work extra hours to meet deadlines.
  • Discretion and an understanding of confidentiality issues.

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