Senior Clinical Project Manager at Enata Pharmaceuticals in Watertown, MA

Job Summary:

The Sr. Clinical Project Manager is responsible for the strategic planning, implementation and management of multiple smaller studies or larger complex clinical trials across indications or programs. This includes overseeing clinical trials from study design through close out; establishing and managing relationships with assigned investigator sites, vendors and consultants to ensure timelines and deliverables are met and that studies are conducted in accordance with appropriate regulatory requirements. The Sr. Clinic Project manager may also have program oversight responsibilities while also managing a study. The Sr. Clinical Project Manager is also responsible for leading or contributing to company process improvement initiatives.

Primary Responsibilities:

• Leads efforts for the selection and oversight of external service providers, including CROs and other vendors as necessary.
• Develops study budget(s); participates in vendor/site budget negotiations and assists with Clinical Trial Agreements as necessary. Develops and maintains study budget tracking tools to ensure that trial costs are accurately tracked and reported.
• Independently 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. Provides support/escalation point for study team leads as needed.
• Recommends strategies for, and oversees, the execution of activities associated with clinical monitoring, safety, eligibility, enrollment, and data consistency.
• 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.
• Prepares or oversees preparation of documentation for assigned trials, e.g., study manuals, monitoring plans, communication plans.
• Participates in the review and finalization of other clinical study-related documents such as protocols, protocol amendments, Clinical Study Reports (CSRs), regulatory submissions, and other publications 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.
• Participates in the ongoing and final review of clinical study data to ensure the data is accurate and complete, and assessment of the impact of this data to the study and program.
• Ensures Trial Master File is accurate and up to date.
• Mentors more junior team members.
• Leads and/or contributes to department initiatives, and assists in the design and implementation of standardized work processes.

Qualifications:

• Bachelor's degree in a scientific discipline.
• Minimum of 8 of years of experience in clinical research working in a pharmaceutical, biotechnology, Contract Research Organization (CRO) or related environment.
• Multi-study experience running Phase I, II & III clinical trials.
• Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting.
• Working knowledge of Good Clinical Practice (GCP).