Clinical Operations Senior Manager

Responsibilities:

• Independently manage clinical trial operational activities from start-up through database lock, accelerating project launch and site start-up/activations while ensuring protocol, GCP, and SOP adherence.
• Lead internal cross-functional study teams and partner with CROs for effective, timely communication and execution within timeline and budget.
• Participate in protocol design, CRO and site selection, and IRB/EC submissions for early and late-phase studies.
• Manage vendors/CROs and serve as primary point of contact; identify risks, resolve issues, manage vendor plans, and review quality metrics.
• Perform/oversee site monitoring visits as needed.
• Support protocol amendments and development/revision of eClinical systems (e.g., EDC, IRT).
• Develop/coordinate study materials (Clinical Monitoring/Data Management Plans, eCRF and guidelines, protocols, consent drafts, specimen instructions, drug order forms).
• Review monitoring reports, protocol deviations, and data listings for quality.
• Coordinate CROs for site selection, IRB submissions, initiation, and close-out.
• Create/manage reports on study progress and key metrics for Senior Management and program teams.
• Coordinate site budget negotiations and oversee site payments.
• Facilitate study drug ordering and drug chain record/accountability; manage non-drug supply ordering/tracking as required.
• Oversee maintenance of clinical trial master files for regulatory/ICH-GCP compliance.
• Provide input to IND filings, CTAs, safety reports, clinical study reports, and ICH-compliant dossier sections (BLA/MAA/NDA, etc.).
• Ensure adverse events/product safety issues are captured and evaluated timely.
• Forecast/reforecast investigational product needs and communicate routinely.
• Support inspection readiness and audits/inspections with CROs and sites; respond to findings.

• BS/BA/BScN or higher in health/biologic sciences (Master's preferred).
• 7+ years clinical operations experience (sponsor or CRO), including 3 years as clinical study lead/project manager.
• Global experience required; cardiovascular, rare disease, and/or Phase 1 experience preferred.
• Experience managing domestic/international Phase 1-3 trials and investigational site start-up.
• Strong project and risk management.
• Excellent written/spoken communication and interpersonal skills.
• Site monitoring and clinical quality compliance experience strongly preferred.
• Advanced GCP knowledge and working knowledge of FDA IND regulations and other country requirements.
• Extensive CRO/vendor selection and management experience.
• Experience delivering clinical study reports and preparing regulatory clinical sections (IND/CTA/BLA/MAA/NDA; eCTD Module 1 data).
• Ability to forecast/manage budgets across studies.
• Proficiency with electronic clinical database software and Microsoft Office.

• Lexington, MA office; onsite five days/week.