Associate Director, Clinical Operations Lead
Primary stack
Job description
About the Position
Associate Director, Clinical Operations Lead (AD COL)
The Associate Director, Clinical Operations Lead is accountable for the operational strategy and end-to-end delivery of assigned clinical studies and/or programs. The role leads cross-functional teams in a matrix environment, ensuring high-quality execution, budget and timeline adherence, effective vendor oversight, and regulatory compliance across high as well as low to moderately complex global studies.
For selected low to moderately complex studies, the AD COL may assume both strategic and day-to-day operational leadership, acting as both SET Leader and SET Manager.
Responsibilities
- Own and drive the clinical operations strategy, providing early input into Clinical Development Plans (CDP) and study design.
- Lead cross-functional study teams and ensure end-to-end execution from protocol development through CSR and TMF archiving.
- Serve as the primary point of contact for study-related matters; manage senior internal and external stakeholders and represent ClinOps in governance forums.
- Accountable for vendor/CRO strategy, oversight, and contract alignment with Business Operations.
- Drive budget strategy, forecasts, timelines, and resource optimization; monitor and report on key study performance metrics.
- Own operational risks, issue escalation, and mitigation, and support audits, inspections, and resolution of findings.
- Define and oversee site engagement strategies, feasibility, and enrollment forecasting.
- Provide functional leadership, coaching, and mentorship across Clinical Operations; contribute to SOPs, process improvements, and knowledge sharing.
- When accountable for multiple studies or a program, ensure appropriate delegation, inter-study efficiencies, and application of learnings.
- Maintain up-to-date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations.
Requirements
- Minimum of 10 years’ relevant clinical research (or related) experience within the pharmaceutical industry.
- Previous experience in leading and managing a team of professional staff.
- A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
- Experience in overseeing large and/or complex global clinical trials.
- Robust budget forecasting and management experience.
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
We Offer
- Competitive salary range: $165,000 - $175,000 per year.
- Contract employment type.
- Remote work option.
About the Company
At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Clinical is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.
Advanced Clinical complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].
Apply for Associate Director, Clinical Operations Lead
© Advanced Clinical. This job description was sourced from the employer's public career page. TheJob is not the employer — we index the posting and route candidates to the source. All content rights and hiring decisions belong to the employer.
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences.