Associate Director, Clinical Programs (Waltham)

Associate Director, Clinical Programs

6-month contract

Prefer Hybrid in Waltham, MA - open to remote

Responsibilities

• Serve as a clinical project team member, working closely with the Clinical Program Manager to lead, oversee, and execute assigned clinical studies, including timelines and key deliverables.
• Operate at a Program Manager level for day-to-day trial operations while contributing to broader program and operational strategy.
• Provide hands-on leadership to initiate and drive study operations, particularly during early phases or transitional periods when program strategy is still evolving.
• Develop, maintain, and track study budgets and financials, including invoice and PO management/reconciliation, accrual tracking and reporting, and re-forecasting in collaboration with Clinical Outsourcing, Finance, and Project Management.
• Oversee and track study status and timelines; contribute to performance metrics and reporting for assigned clinical studies.
• Lead and contribute to the development of clinical study documents, including informed consent forms (ICFs), monitoring plans, recruitment plans, and other study-related materials.
• Partner with the Clinical Program Management team on CRO and vendor selection, including RFP processes, contract negotiations, and budget management; serve as a key decision-maker in CRO selection.
• Oversee and collaborate directly with CROs, vendors, investigators, monitors, and other external partners.
• Lead and participate in cross-functional clinical team meetings; act as the primary point of contact for study-level updates and communication.
• Lead and coordinate study start-up activities, including feasibility assessments, investigational product and materials preparation, trial master file (TMF) setup, CRF development, regulatory documentation, and site contracting in collaboration with internal teams.
• Support and coordinate data management activities, including database setup, user acceptance testing (UAT), development of edit checks and monitoring guidelines, and data cleaning efforts across sites and systems.
• Assist the Clinical Program Manager in coordinating the receipt of ancillary data (e.g., safety labs, analytical labs, IVRS/randomization data) to ensure completeness at database lock.
• Contribute to SOP development, process improvements, and training of junior Clinical Trial Managers and Clinical Trial Assistants (CTAs), as well as other departmental initiatives.
• Independently manage and deliver complex and/or multiple clinical studies, providing senior-level, hands-on leadership to drive efficient operational execution.

Qualifications

• Bachelor’s degree in a scientific or healthcare-related field required; Master’s degree preferred.
• 10+ years of clinical research experience (or equivalent senior-level experience) within a pharmaceutical, biotechnology, or CRO environment; monitoring experience is a plus.
• Strong knowledge of GCP and ICH guidelines for conducting clinical trials.
• Demonstrated leadership, interpersonal, organizational, and multitasking skills.
• Excellent attention to detail and strong problem-solving abilities.
• Ability to work effectively both independently and within a team environment.