The Clinical Program Manager (CPM) is accountable for leading day-to-day operations of one or more clinical studies, ensuring efficient delivery of clinical trials in a matrix environment. This role is responsible for working with and leading selected vendors in the execution of the clinical trials assigned. This position will report to a Clinical Program Director.
Responsibilities:
- Lead cross functional study management team to ensure effective planning, implementation and execution of clinical trials within agreed timelines, resources and budget.
- Facilitate operational activities pertaining to the execution of Ph I-IV clinical trials from study start through close-out.
- Primary contact for functional area representatives and vendors responsible for protocol execution.
- Provide oversight of internal clinical operations team members, CROs, service providers and consultants that are involved in assigned studies.
- May assist in the development and review of Investigator Brochure, study protocols, case report forms, and clinical study reports.
- Development and review of informed consent forms, study plans, study materials and tools.
- Establish study milestones and ensure accurate tracking and reporting of study progress.
- Preparation of study budgets and timelines.
- Ensure studies are managed and executed in accordance with ICH GCP, regulations, the protocol, and company SOPs.
- May conduct site visits (in conjunction with CRO, if applicable) for oversight, site evaluation, initiation, monitoring, or close-out activities.
- Participate and respond to Quality Assurance and regulatory authority inspection audits.
- Participating in service provider selection process as a part of outsourcing activities.
- Responsible for selection and study specific training of CRO study staff, monitors, investigational sites, and service providers.
- Plan and coordinate Investigator Meetings.
- Recommends and implements innovative ideas to increase efficiency and quality of study management activities.
- Mentoring junior team members.
Qualifications:
- Bachelor’s degree, preferably in a scientific field.
- Minimum of 7+ years of related industry experience in the pharmaceutical industry or equivalent, with 5+ years of study management experience at a Sponsor or CRO, recent oncology experience required.
- Proven ability to lead a study team.
- Excellent communication skills both verbal and written are required.
- Flexibility and willingness to step in and be a team player.
- Strong problem-solving skills with the ability to focus on time-sensitive objectives.
Skills/Abilities:
- Thorough understanding of ICH GCP guidelines.
- Familiar with advanced concepts of clinical research and experience in driving execution, from study start-up through study closure (e.g., data management, safety, biostatistics, medical writing).
- Self-motivated, assertive, and able to function independently and as part of a team.
- Effective in selection of investigative sites, CROs, and vendors and management of external resources.
- Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners).
- Proven problem-solving and decision-making skills.
- Excellent planning and organization skills.
- May have line management responsibilities.
- Excellent IT Microsoft skills and experience using clinical trial management web-based systems (i.e. EDC, IRT, CTMS, eTMF, etc.).
- Ability and willingness to travel 10-20% (domestic and international).
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