Senior Manager, Clinical Trial Lead

$165,000 - $185,000/Yr

Olema Pharmaceuticals - Boston, MA

Full-time - Mid Level

Boston, MA

Administrative and Support Services

About the position

The Senior Manager, Clinical Trial Lead (CTL) at Olema Oncology is responsible for the day-to-day management of clinical trials, ensuring compliance with regulatory guidelines and company standards. This role involves overseeing clinical trial vendors, managing study deliverables, and collaborating with cross-functional teams to deliver quality studies on time and within budget. The CTL will also mentor junior staff and support the development of clinical trial documentation and processes.

Responsibilities

• Manage all aspects of clinical trials, including study vendor management and CRO oversight.
• Lead or support the cross-functional study execution team with study deliverables.
• Ensure clinical trials are managed in accordance with ICH GCP, regulations, and company SOPs.
• Assist in preparation and review of clinical trial documentation such as protocols and consent forms.
• Triage CRO and clinical site questions and facilitate cross-functional study team meetings.
• Partner with eTMF team to maintain the Trial Master File throughout the trial.
• Coordinate resolution of audit findings and ensure audit-ready condition of clinical trial documentation.
• Participate in service provider selection and outsourcing activities.
• Proactively identify and resolve clinical project issues and participate in process improvement initiatives.
• Assess operational feasibility and recommend study execution plans and site selection.
• Facilitate the development of clinical trial agreements with the legal group.
• Support oversight of clinical trial budgets and provide financial reporting.
• Negotiate and finalize site contracts and budgets.
• Perform ongoing data review and oversight of site visits.
• Ensure tracking and review of protocol deviations and assess their impact on study data.
• Review and approve clinical invoices against the approved scope of work.
• Manage and mentor junior Clinical Operations staff and may have direct reports.
• Support development and review of Clinical SOPs and other department initiatives.
• Travel as needed to sites, conferences, and industry meetings.

Requirements

• Bachelor's Degree is required; advanced degree is preferred.
• 8+ years of clinical research experience and 3+ years of clinical trial management experience.
• Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management.
• Strong clinical project management skills and proven leadership abilities.
• Excellent communication skills for effective information dissemination.
• Global and Phase 1-3 trial experience is required, with oncology experience preferred.
• Experience developing trial plans and strategies for site monitoring and risk mitigation.
• Extensive clinical research knowledge and understanding of clinical trial methodology.
• Experience managing CROs/vendors and scopes of work.
• Proficient in Microsoft Office Suite and working knowledge of MS Project.

Nice-to-haves

• Experience in breast cancer clinical trials is preferred.
• Ability to develop Therapeutic Areas knowledge through training and conferences.

Benefits

• Competitive compensation package including base pay, equity, and bonuses.
• Flexible and friendly work environment.
• Opportunities for long-term career development.