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Clinical Project Manager
The Clinical Project Manager is responsible for the planning, implementation, execution, oversight and management of Independent Research (IR) studies per Global Medical Research (GMR) SOP(s). The incumbent may manage clinical outsourcing to vendors as needed. May author, review and approve various study related documents and plans. Identifies issues, interprets data, and suggests and implements solutions and mitigation as required. Responsible for the budgetary and enrollment forecasting and tracking of each assigned IRs and develops and oversees study timelines. Tracks compliance with contractual and protocol reporting requirements and escalates issues as appropriate per the relevant business plan/SOP.
- Represents and leads the study team to develop, execute and manage global IR programs in accordance with GMR's goals, strategy, business plans and SOPs, in compliance Good Clinical Practices (GCP) and ICH Guidelines.
- May review and contribute to the content of Independent Research Review (IRC) Committee meetings, clinical study documents, posters, presentations and publications.
- Maybe responsible for the development and implementation of study feasibility and site selection requirements.
- The CPM maybe involved in the vetting on new IR proposals, investigators, and institutions
- Assist and may independently train IR sponsors on their responsibilities and interactions with as an investigator and sponsor of IR.
- Assists with the planning and execution of applicable investigator's meetings, joint steering committee meetings, etc., as needed
- Maintains accurate metrics for assigned IR programs
- Responsible for IR budget discussions and forecasting, while acting as a liaison with the Finance Department
- Ensures the delivery of clinical trial supplies (drug supply, lab kits) in collaboration with the clinical supply team.
- Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
- Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
- Manages clinical vendor activities to ensure quality and alignment with and regulatory requirements.
- May supervise, including performance management, and mentor Clinical Trial Associates, Lead Clinical Research Associates, and Clinical Trial Managers
- Monitors progress of IRs and produces regular and ad hoc reports, slides, and presentations as required.
- Reviews, approves, tracks and ensures compliance with contractual reporting requirements across all IRs.
- Provides IR reference material for responses during regulatory inspections and NDA submission(s).
- Continually collaborates with cross functional teams on audit readiness plans and procedures.
- May assist Quality Department with independent or internal/external monitoring/auditing of IR
- May execute compliance visits at sponsors
- Reviews and monitors compliance with trial budgets and contracts with Sponsors, Institutions, vendors, and investigative sites, as applicable.
- Evaluates site and study performance metrics against agreed upon budget, deliverables and timelines.
- Assists GMR/GMSA Director with IR budget in fiscal planning/forecasting
- Works with the Regulatory/PVG department to maintain an accurate summary of IR safety information (i.e. DSUR and IB updates)
- Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans/contracts/protocols through regular investigator site /clinical vendor contact.
- Reviews and ensures accuracy and necessary follow-through regarding correspondence and reports relating to the safety and regulatory IR updates
- Continuous broadening of knowledge of therapeutic areas, current medical practice and pharmaceutical regulations to ensure best practice across all activities.
- Continually supports/helps to develop department initiatives and process improvements.
- May manage and/or mentor other GMR/GMSA Department staff (e.g. CTAs, CTM, etc.)
- Works collaboratively with Medical Science Liaisons (MSLs) to ensure consistent strategic messaging to all active and prospective investigators
- Attend relevant symposia, conferences and scientific meetings, as necessary.
- Up to 15% domestic and/or international travel may be required.
- Bachelor's degree or nursing qualification is required. Scientific/health care field preferred, but not required.
- 5+ years' experience working in relevant clinical research preferably in clinical operations within a pharmaceutical company or CRO or similar organization.
- Previous experience managing independent research programs and/or company sponsored trials required.
- Prior experience working on collaborative research engagements preferred
- Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
- Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
- Ability to work/communicate successfully within a cross-functional team.
- Strong knowledge of applicable computer and project management software packages (Microsoft Office ® and Smartsheet ®)
- Excellent written and oral communication skills.
- Strong interpersonal skill set to interact with investigators, vendors, and individuals at all levels of the organization.
- Working knowledge of current global regulatory requirements and guidelines governing clinical research and GCP
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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