Enanta Pharmaceuticals, Inc. Watertown , MA 02472
The Sr. Clinical Trial Manager is responsible for planning, implementing and managing a small number of studies of basic to moderate complexity or supporting more complex, multicenter studies, overseeing specific study activities and/or vendors. The Sr. Clinical Trial Manager is also responsible for leading or contributing to company process improvement initiatives.
Primary Duties and Responsibilities:
Participates in the selection and oversight of external service providers, including CROs and other vendors as necessary.
Manages responsible study(ies) within agreed timelines and budget and in accordance with internal SOP's and GCP, and coordinates cross functional efforts to achieve study objectives and goals. Identifies and communicates study issues that will impact budget, resources and timelines.
Assists in the development of clinical trial budgets; supports efforts to revise budget forecast as needed; develops and maintains study budget tracking tools to ensure that trial costs are accurately tracked and reported.
Develops and oversees study quality metrics to ensure that subject recruitment goals are met
Establishes and maintains relationships with assigned investigator sites, vendors and consultants.
Prepares potential investigator site lists and assists with their evaluation for inclusion in the study, ensuring proper prequalification of clinical sites.
Oversees monitoring activities and conducts co-monitoring visits as needed.
Prepares documentation for assigned trials, e.g., study manuals, monitoring plans, communication plans, and may participate in the review and finalization of clinical protocols, protocol amendments Clinical Study Reports (CSRs) and other study documents as required.
Ensures documentation prepared internally or by CRO(s) is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies/programs.
May participate in the ongoing and final review of clinical study data to ensure the data is accurate and complete.
Oversees Trial Master File (TMF) and maintains accurate and updated study files.
Leads and/or contributes to department initiatives, and assists in the design and implementation of standardized work processes.
Interpersonal Skills - Must have the communication and interpersonal skills needed to lead cross functional teams.
Communication Skills Strong oral and written communications.
Productivity/Organizing/Planning Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
Strategic Thinking Capable of proactively identify project challenges and risks, and proposing appropriate and strategic solutions to issues.
Collaboration & Teamwork Strong collaboration & teamwork, communications influence, planning & organizing, driving results and problem solving.
Bachelor's degree in a scientific discipline.
Minimum of 6+ of years of experience in clinical research working in a pharmaceutical, biotechnology, Contract Research Organization (CRO) or related environment.
Study management experience running Phase I & II clinical trials.
Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting.
Working knowledge of Good Clinical Practice (GCP).