ABOUT THE ROLEReporting to the Director of Clinical Operations, the Senior Clinical Trial Manager (Sr. CTM) will lead the day-to-day execution and management of clinical trials, ensuring studies are conducted efficiently, on time, within budget, and in compliance with GCP and regulatory requirements.
This role is a hands-on operational leader at the study level, responsible for driving execution across study start-up, enrollment, maintenance, and close-out activities. The Sr. CTM will work closely with cross-functional partners and oversee CROs and vendors to ensure high-quality delivery of clinical trial milestones. There may be the opportunity to mentor junior members of the Marea team.
In this role, the Sr. CTM will be a key clinical operations leader supporting our MAR002 program, specifically driving the execution of a Ph. 2/3 study to support product registration. MAR002 is a first-in-class- and potentially a best in disease anti-growth hormone receptor antibody monoclonal antibody indicated for growth hormone control (IGF-1 normalization) in acromegaly.
This is a full-time, South San Francisco-based position with the expectation of working on-site at least three days per week.
KEY RESPONSIBILITIESStudy Execution Leadership & Management- Support program lead with setting and timely executing the development strategies for the clinical studies.
- Responsible for the strategic and operational oversight, management, execution, and delivery of the clinical studies for MAR002 and related clinical program activities.
- Lead the Study Management Team (SMT) for assigned clinical study.
- Resolve and/or escalate issues raised by the clinical operations team or the SMT.
- Ensure consistency between studies for assigned clinical program.
CRO and Vendor Management- Support vendor selection, including request for proposals, leading bid defense meetings, critical review of contracts and negotiation of work orders.
- Oversee CROs and other selected vendors on a product level including setting and monitoring key performance indicators and ensuring successful execution of the clinical program/studies and may co-lead operational governance meetings.
Study Planning, Risk Mitigation, and Enrollment- Identification and oversight of potential challenges or risks with clinical study conduct and implementation of mitigation plans.
- Support the development and execution of clinical site engagement and subject recruitment strategies for assigned study.
Trial Design, Documentation, and Submissions Support- Provide input and clinical operations perspective on clinical trial design.
- Author, provide input and/or oversee the development of key study level documents as well as provide support for regulatory submissions.
Study Budget Management & Operational Excellence- Oversee financial aspects of assigned clinical study, including preparing related operating plans and ensuring adherence to planned study budgets.
- Support Clinical Operations department head with strategic initiatives and the implementation of those initiatives for process and operational improvements.
Inspection Readiness, Quality, and SOP Support- Oversee/co-lead inspection readiness activities as it relates to clinical study execution and act as subject matter expert during regulatory inspections.
- Support Clinical Operations department on clinical SOP development.
- Support Clinical Operations department on ad hoc initiatives to leverage best practices as well as new technologies and applications for clinical study conduct.
QUALIFICATIONS- BA/BS or higher degree in a relevant scientific discipline required.
- Significant experience (6 - 9 years) of clinical research / clinical operations and organizational management within the pharmaceutical industry; Biotech/small pharma experience preferred.
- Global Ph 2 - 3 clinical trial experience required
- Experience leading and working on cross functional study execution teams.
- Demonstrated ability to present complex information to management, vendors and external audiences.
- Demonstrated ability to manage and communicate effectively with vendors including negotiating contracts, drafting and reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints.
- Strong attention to detail and ability to generate high quality work outputs (e.g. presentations, reports, dashboards, etc.)
- Demonstrated ability to work in a fast-paced environment with multiple competing tasks and demands, across multiple time zones.
- Demonstrated ability to work independently, take initiative, complete tasks to deadlines and support Clinical Operations team in doing the same.
- Excellent written and oral communication skills.
- High level of professionalism with internal and external stakeholders.
- Demonstrated problem-solving skills and conflict management skills.
- In-depth knowledge of current regulatory requirements and guidelines governing clinical research (e.g., ICH-GCP).
PAY RANGEThe salary range for this role is $180,000. - $220,000. Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.
WORKING CONDITIONS - Prolonged periods of being at a stationary desk or work computer
- Ability to occasionally adjust, handle, or move objects up to [20] pounds
- Transparently and timely communicating with others to exchange information
- Occasional travel as required to meet business objectives
