Associate Director Clinical Operations (Waltham)

Associate Director, Clinical Programs

Location: Waltham, MA 02451, Hybrid preferred (open to remote candidates)

Pay Rate: Up to $140 an hour or about $288,000 a year

Job Type: Long Term Contract

Position Overview

The Associate Director, Clinical Programs is responsible for the oversight, coordination, and execution of clinical studies supporting broader clinical programs. This role combines hands-on trial management with program-level operational leadership to ensure studies are executed efficiently and aligned with program objectives.

Key Responsibilities

• Serve as a core clinical project team member, working closely with the Clinical Program Manager (CPM) to lead the execution, oversight, and delivery of assigned clinical studies, timelines, and key milestones.
• Operate at a program-manager level for day-to-day trial operations while contributing to broader program strategy and operational planning.
• Provide hands-on leadership to initiate and advance studies, particularly during early phases or transitional periods where strategy is still evolving.
• Develop, manage, and track study budgets, including financial reporting, invoice and PO reconciliation, accrual tracking, and forecasting in collaboration with Clinical Outsourcing, Finance, and Project Management.
• Monitor study progress, timelines, and performance metrics, ensuring accurate and timely reporting.
• Lead and contribute to the development of key clinical study documents, including informed consent forms (ICFs), monitoring plans, recruitment strategies, and other study-related materials.
• Partner with Clinical Program Management in the selection of CROs and vendors, including managing the RFP process, and leading contract and budget negotiations.
• Serve as a key decision-maker in CRO selection alongside the CPM and Clinical Program Management team.
• Oversee and manage relationships with CROs, vendors, investigators, monitors, and other external stakeholders.
• Lead cross-functional clinical team meetings and serve as the primary point of contact for study-level updates.
• Direct and coordinate study start-up activities, including feasibility assessments, investigational product and material preparation, trial master file (TMF) setup, CRF development, regulatory documentation, and site contracting.
• Support data management activities, including database development, user acceptance testing (UAT), edit check input, and data cleaning efforts across sites and vendors.
• Collaborate with the CPM to ensure timely receipt and integration of ancillary data (e.g., safety labs, analytical data, IVRS randomization data) for database lock.
• Contribute to SOP development, process improvements, and training/mentorship of junior Clinical Trial Managers and Clinical Trial Assistants (CTAs).
• Independently manage complex or multiple clinical studies, providing senior-level leadership to drive execution and results.

Qualifications

• Education: Bachelor’s degree in a scientific or healthcare-related field required; Master’s degree preferred.
• Experience: 10+ years of clinical research experience within pharmaceutical, biotechnology, or CRO environments; monitoring experience is a plus.
• Strong knowledge of GCP/ICH guidelines and clinical trial regulations.
• Demonstrated leadership, organizational, and multitasking abilities.
• Excellent problem-solving skills and attention to detail.
• Strong interpersonal and communication skills, with the ability to work effectively in cross-functional teams.

General Notes

• This is a senior-level, hands-on leadership role ideal for candidates who can operate both strategically and tactically within clinical operations.
• Candidates must be comfortable driving studies forward in dynamic and evolving environments.