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.

Key Accountabilities

• 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.

Essential Requirements:

• As a guide, 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

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group 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 Group 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].