Clinical Trial Manager

Role Summary

Clinical Trial Manager role supporting the Clinical Operations team in day-to-day management and execution of clinical trials, with a focus on study management and vendor oversight.

Responsibilities

• Accountable for select aspects of clinical trial operations, including CRO and third-party vendor management, site management, and timeline and budget.
• Facilitate the RFP process for selecting CROs or new vendors and participate in evaluation of potential services.
• Create or assist in development/review of study documents and systems (protocol, ICF, monitoring plan, study manuals, eCRFs, IVRS, etc.).
• Own and/or support study timelines and study status; proactively communicate updates and risks to timelines, quality, and budget-related items.
• Manage and monitor progress of study deliverables (e.g., site activations, enrollment).
• Create, manage, and negotiate clinical site budgets and/or sponsor oversight of third parties responsible for these activities.
• Manage study-specific budget activities including review/approval of vendor invoices, identify out-of-scope activities, and support monthly/annual forecasting.
• Manage/Support monitoring (trip report review, creation, and plan compliance).
• Assist in identifying clinical trial sites and contribute to site feasibility and site selection decisions.
• Communicate study status internally and externally; develop proactive contingency plans for study-level risks.
• Contribute or organize Investigator Meetings and CRA trainings.
• Provide expertise to study drug and clinical supplies forecasting; oversee drug accountability and reconciliation.
• Oversee maintenance of study data/files in CTMS and eTMF; support inspections and audits.
• Ensure compliance with clinical trial requirements and SOPs; contribute to development of best practices and SOPs.

Qualifications

• Bachelor‚Äôs degree required.
• 5-7 years of relevant Clinical Operations experience in biotech/pharma; minimum of 2+ years independent trial management preferred.
• Excellent organizational and time management skills.
• Strong communication skills; ability to articulate timelines, deliverables, and study questions/issues across cross-functional teams.
• Experience managing and developing study documents.
• Proactive problem solving; able to meet deadlines and manage multiple projects in a fast-changing environment.
• Knowledge of ICH/GCP and regulatory guidelines.
• Vendor management skills with ability to handle conflicts.
• Ability to lead study teams and build cross-functional relationships.
• Technical proficiency in MS Word, Excel, EDC, IVRS/IWR, etc.
• Commitment to integrity, professionalism, and patient respect.

Skills

• Operational management
• Vendor and site management
• Budgeting and forecasting
• Study documentation and CTMS/eTMF management
• Risk assessment and contingency planning
• Investigator meetings and CRA training coordination

Education

• Bachelor‚Äôs degree required