Senior Clinical Trial Manager

Aditum Bio•Oakland, MA

About The Position

The Senior Manager, Clinical Operations will play a key role in the planning, execution, and oversight of early-stage clinical trials across assigned Aditum Bio portfolio companies. Reporting to the Senior Director, Clinical Operations, this individual will serve as an operational lead for one or more Phase I and Phase II studies, partnering closely with internal cross-functional teams and external CROs to ensure studies are conducted efficiently, compliantly, and with a high standard of quality. This is a hands-on role that requires strong operational execution, vendor oversight, and the ability to thrive in a fast-paced, lean biotech incubator environment supporting multiple portfolio companies.

Requirements

Bachelor's degree in Life Sciences or a related scientific discipline; advanced degree preferred.
Approximately 7+ years of progressive clinical operations experience within biotechnology, pharmaceutical, or CRO environments.
Demonstrated experience managing Phase I and Phase II clinical trials with increasing operational responsibility.
Experience serving as the operational lead for one or more clinical studies, including oversight of CROs and external vendors in a fast-paced and dynamic environment.
Experience reviewing data to identify discrepancies or trends that require clarification
Strong understanding of clinical trial startup, execution, closeout, and vendor management in global or multi-center studies.
Working knowledge of ICH-GCP, FDA, EMA, and other applicable clinical research regulations.
Experience managing study timelines, budgets, study risks, and operational performance metrics.
Demonstrated ability to successfully manage multiple priorities across concurrent development programs in a lean, matrixed organization.
Strong organizational, project management, analytical, and problem-solving skills with exceptional attention to detail.
Excellent interpersonal and communication skills with the ability to build productive relationships across internal teams, investigators, vendors, and executive leadership.

Nice To Haves

Biotech experience preferred

Responsibilities

Lead day-to-day operational management of Phase I–II clinical trials across one or more portfolio companies.
Partner with the Senior Director, Clinical Operations to execute study strategy, timelines, and risk mitigation plans.
Develop study plans, enrollment forecasts, recruitment strategies, and tracking tools.
Manage study start-up, including site feasibility and selection, regulatory/ethics submissions, vendors, investigator meetings, and patient enrollment.
Monitor study performance, identify and escalate risks, and implement mitigation plans.
Review monitoring reports, protocol deviations, vendor deliverables, and study metrics to ensure quality oversight.
Oversee CROs and vendors to ensure quality, timelines, budgets, and contractual deliverables are met.
Serve as the primary study clinical operations lead, partnering with Clinical Development, Biometrics, Data Management, Regulatory, Quality, and other functions.
Lead study team and vendor governance meetings, driving accountability and timely issue resolution.
Oversee studies from start-up through database lock and closeout, ensuring ICH-GCP compliance and inspection readiness.
Partner with the eTMF manager and CRO to maintain a complete, current, and inspection-ready TMF.
Support clinical trial audits and inspections.
Participate in review of patient profiles, tables, listings, and figures.
Support study budgets, forecasts, invoice review, and clinical trial spend management.
Improve clinical operations processes, SOPs, templates, and best practices for use across the portfolio.