Associate Director, Clinical Operations (Sponsor‑Aligned)

Location: Remote with 20–30% travel

Department: Clinical Operations

Reports to: Director, Clinical Operations

Key Responsibilities

Leadership & People Management

• Provide direct leadership to 10–15 DLMs and indirect oversight to 150–175 clinical operations staff across multiple functions.

• Manage staff in alignment with organizational policies and applicable regulations, including planning, assigning, and directing work.

• Conduct performance appraisals, guide professional development, and address employee relations issues.

• Lead hiring and selection activities for clinical staff; participate in interviews and ensure effective onboarding and training.

• Ensure all staff have appropriate systems access, materials, and training to perform their roles successfully.

• Oversee execution of training plans, SOP reviews, and ongoing competency development.

Operational Oversight

• Allocate resources to clinical research projects by assigning staff based on experience, training, and study needs.

• Participate in coordinated resourcing processes to ensure optimal staffing across FSP accounts.

• Monitor and evaluate the quality of clinical work through regular review of deliverables, customer feedback, and project outcomes.

• Identify quality risks and issues, develop corrective action plans, and ensure timely resolution.

• Ensure staff meet workload, quality, and budget expectations through ongoing review and reporting.

Client Engagement & Cross‑Functional Collaboration

• Serve as a key liaison to sponsor partners, supporting day‑to‑day governance, escalations, and relationship management.

• Collaborate with regional and global clinical teams, as well as cross‑functional leadership, to address project challenges and deliver exceptional customer service.

• Support multiple FSP accounts, ensuring alignment with client expectations and operational standards.

• Participate in corporate and organizational quality or process improvement initiatives.

Travel Requirements

• Travel 20–30% to meet with clients, support DLMs, and participate in onsite leadership activities.

Qualifications

Required

• 8–12+ years of progressive clinical research experience, including 7–10+ years leading Phase I–IV clinical trials within a sponsor, CRO, or FSP environment.

• Proven ownership of end‑to‑end study delivery, including CRO/vendor oversight, budget and timeline management, TMF quality, and inspection readiness in alignment with ICH‑GCP and global regulatory expectations.

• Demonstrated people leadership experience, managing and developing CTMs, CRAs, CTAs, Study Start‑Up teams, or similar clinical operations functions.

• Strong track record of cross‑functional collaboration with clinical monitoring, study start‑up, data management, regulatory, safety, and biometrics teams.

• Extensive experience interacting with sponsor partners, including escalation management, governance participation, and relationship building.

• Bachelor’s degree required; advanced degree preferred.

• Career progression that reflects increasing responsibility (e.g., CRA → CSM/CTM → Associate Director or equivalent).

• Experience managing multiple concurrent studies or a fast‑paced, complex clinical program with both regional and global exposure.

• Ability to operate with Director‑level judgment, autonomy, and strategic insight in a matrixed environment.

Preferred

• Broad therapeutic area background with preference for Oncology, Cardiology, In‑Vitro Diagnostics, and Medical Devices.

• Prior experience supporting FSP delivery models or sponsor‑aligned operational structures.

• Strong analytical, problem‑solving, and quality‑focused mindset with experience driving process improvement initiatives.

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