Clinical Trial Manager

Clinical Operations Lead – Early Clinical Stage Development

6-month contract

Hybrid - 3 days/week onsite in Waltham, MA

Role and Responsibilities

• Develop strategy and methodology for clinical operations programs.
• Ensure clinical trials are conducted in compliance with applicable regulatory requirements and are inspection-ready.
• Oversee planning, execution, and delivery of clinical programs/trials from Start of Development through Proof of Clinical Principle/Concept within assigned indications or assets, emphasizing speed and value.
• Manage budgets and timelines while supporting implementation aligned with relevant local regulations and international ICH-GCP guidelines.
• Provide operational and strategic input on training materials, program-specific standards, clinical development plans, and clinical sections of regulatory documents (e.g., Investigator Brochure, clinical study reports, safety updates, briefing books, submission dossiers).
• Ensure timely execution and contribute to asset evidence plans and clinical trial protocols.
• Collaborate with Clinical Trial Supply to determine comparator sourcing strategy when applicable.
• Drive site selection and subject recruitment programs to meet enrollment targets.
• Participate in database creation and user acceptance testing; provide input on edit checks, monitoring guidelines, and data cleaning activities between study sites, data management, and field monitors.
• Participate in SOP development, process mapping, training of CTAs, and other departmental activities.
• Partner and liaise with internal team members globally, including technical leads, project management, and regulatory affairs.

Minimum Education & Experience Requirements

• M.S. or Ph.D. in basic sciences with 5 years of Clinical Operations experience within a biotechnology, pharmaceutical company, or CRO.
• Ability to identify and champion more efficient and effective methods/processes for delivering Clinical Operations, focusing on key performance metrics including reliability, efficiency, cost, and quality.
• Thorough knowledge of FDA and/or EMEA regulations, ICH guidelines, and GCPs governing clinical trials. Experience leading global trials outside the U.S./EU/Asia/Americas is preferred.
• Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, and budget management.
• Demonstrated experience in successful planning and implementation of clinical trial operations.
• Experience developing clinical protocols, SOPs, clinical study reports, and other documents to support New Drug Applications (NDA) on time, within budget, and in compliance.
• Proven track record of leading and driving business process transformation and organizational culture change, as well as delivering on programs with complex business requirements.