Associate Director, Clinical Operations

IQVIA•Durham, NC

4d•Remote

About The Position

The Associate Director, Clinical Operations (Sponsor-Aligned) will provide direct leadership to 10-15 DLMs and indirect oversight to 150-175 clinical operations staff across multiple functions. This role involves managing staff in alignment with organizational policies and applicable regulations, including planning, assigning, and directing work. The position also requires conducting performance appraisals, guiding professional development, addressing employee relations issues, and leading hiring and selection activities for clinical staff. Ensuring staff have appropriate systems access, materials, and training, and overseeing execution of training plans, SOP reviews, and ongoing competency development are key responsibilities. The role also includes allocating resources to clinical research projects, monitoring and evaluating the quality of clinical work, identifying quality risks, and ensuring staff meet workload, quality, and budget expectations. Additionally, the Associate Director will serve as a key liaison to sponsor partners, collaborate with regional and global clinical teams, and support multiple FSP accounts. Travel of 20-30% is required to meet with clients, support DLMs, and participate in onsite leadership activities.

Requirements

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.
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.

Nice To Haves

Advanced degree 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.

Responsibilities

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.
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.
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.