Senior Manager, Clinical Operations Lead
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Job description
About the Position
Senior Manager, Clinical Operations Lead
The Senior Manager is responsible for the day-to-day operational leadership and execution of global clinical studies, ensuring high-quality delivery across the full study lifecycle. Operating in a matrix, cross-functional environment, the Senior Manager translates agreed operational strategy into executable plans, drives timelines and performance, oversees vendors, and ensures readiness, compliance, and inspection preparedness.
Responsibilities
- Translate operational strategy set by the SET Leader and/or program leadership into clear, executable study plans.
- Own day-to-day operational delivery across the full study lifecycle, from start-up through CSR completion.
- Lead study start-up and readiness activities, including timelines, operational planning, and execution readiness.
- Contribute to feasibility assessments, country and site selection, and enrollment planning, in collaboration with COMs and study partners.
- Drive development and implementation of Study Management Plans and associated operational documentation.
- Oversee CROs and vendors, ensuring execution rigor, performance management, and issue escalation.
- Proactively manage operational risks, identify mitigation strategies, and implement corrective actions as needed.
- Act as the primary operational interface with external providers.
- Drive and maintain study timelines, enrollment forecasting, and operational milestones.
- Track and report key study performance indicators (KPIs), including start-up progress, enrollment, and data quality/timeliness.
- Ensure studies are conducted in compliance with GCP, regulatory requirements, SOPs, and internal standards.
- Maintain TMF completeness and quality and ensure ongoing inspection readiness.
- Coordinate IMP and non-IMP supply needs in collaboration with CTS and other functional partners.
- Support planning and execution of investigator meetings, study team training, and key operational meetings.
- Serve as a key point of contact for study-level operational execution, facilitating collaboration and alignment with internal and external stakeholders.
Requirements
- A minimum of 6+ years’ relevant clinical research experience within the pharmaceutical industry.
- A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
- Experience in overseeing global clinical trials (pharmaceutical or research institute).
- Budget forecasting and management.
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical trial process.
We Offer
Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
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].
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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.