- Company Name
- Bayside Solutions
- Job Title
- Clinical Program Manager (CPM)
- Job Description
-
**Job Title:** Clinical Program Manager (CPM)
**Role Summary:**
Lead cross-functional clinical trial execution, overseeing timelines, governance, and risk management across multiple studies or indications. Serve as strategic advisor to senior leadership, ensuring regulatory compliance, resource optimization, and quality delivery.
**Expectations:**
- Execute trial strategy and maintain study timelines for multiple projects.
- Ensure audit/inspection readiness and TMF compliance.
- Drive process standardization, vendor selection, and resource allocation.
- Mentor and develop junior trial staff.
**Key Responsibilities:**
- Lead Clinical Study Execution Team (CSET) meetings, driving consensus on milestones.
- Develop and monitor trial execution strategies, budgets, and risk mitigation plans.
- Maintain TMF compliance and audit readiness.
- Draft study documents (protocols, ICFs, CRFs, monitoring plans) and collaborate with cross-functional partners.
- Standardize processes and tools across studies.
- Contribute to RFP development, CRO/vendor selection, and oversight of external partners.
- Provide training to CROs, vendors, investigators, and study coordinators.
- Participate in recruiting and hiring of clinical trial staff.
- Mentor Clinical Trial Managers, Associates, and Assistants.
- Analyze operational data to inform decision-making and fiscal responsibility.
**Required Skills:**
- 8+ years in pharmaceutical or biotech clinical operations or research.
- Expert knowledge of FDA/EMA regulations, ICH Guidelines, GCP, and clinical SOPs.
- Strong strategic thinking, program-level planning, and risk management.
- Experience with eTMF, EDC, IRT, and CTMS systems.
- Excellent cross‑functional collaboration, communication, and decision‑making.
- Ability to multitask, prioritize, and meet critical deadlines.
**Required Education & Certifications:**
- Bachelor’s degree in Life Sciences, Nursing, or related scientific discipline (BS, BA, or RN).
- Professional certifications (e.g., CTP, CRA) preferred but not mandatory.