Title:                   Sr. Clinical Data Manager

Location:           Cambridge, MA / Remote / Hybrid

Reports to:        Vice President, Head of Clinical Operations

About Vedanta Biosciences:

Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets include potential first-in-class oral therapies, VE303, a Phase 3-ready candidate for recurrent C. difficile infection, and VE202, in a Phase 2 trial for ulcerative colitis. Vedanta’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.

The Role:

The Sr. Clinical Data Manager is a strong communicator who is responsible for successful delivery of Data Management deliverables meeting program needs. This individual is committed to the highest quality outputs while serving as the primary liaison for Data Management issues, oversees milestones and tasks for assigned projects, and ensures timely completion of all project status reporting. The Sr. Clinical Data Manager will work with internal and external team members, driving clinical data management plans and will oversee CRO data management teams. This person will review data management plans for content and structure, provide case report form design oversight, and ensure quality control steps are properly planned and completed on all studies.

Here’s What You’ll Do:

• Contribute to the decision-making process involving data management (DM) issues for large or complex clinical studies. Communicate how DM decisions impact other functional areas and the company as a whole
• Provide oversight and participate in study setup and initiation procedures such as CRF design, database design, edit check design/review, DMP (Data Management Plan) review/approval, and annotated CRF design; this may include the performance of user acceptance testing.
• Ensure completeness and accuracy of all study documentation; this may include the need to perform eTMF quality checks. Coordinate and participate in the review of clinical data, analysis tables/listings/figures, and patient profiles for data consistency and accuracy
• Address/respond to data issues, as needed, identified by cross-functional team members
• Apply experience and education to initiate and develop new and more efficient processes and procedures for study setup, maintenance, closure and archiving activities to meet business needs
• Develop and implement changes to DM guidelines and quality processes to ensure clinical databases, external data files and analysis datasets are designed in a standard, accurate, complete and consistent format conducive to analysis and regulatory submissions by working with lead CRO data manager or equivalent
• Develop/utilize study metrics to monitor quality, project status, activities, and budget and work with Manager to identify trends and provide updates/recommendations to Sr. Management on opportunities for improvements; for some studies, this may include the generation, review and/or follow up, as needed, on study-level operational performance and quality metrics
• Assist in the coordination of the acquisition and development of tools to support data management tasks internally and externally with DM vendors; this may include development of specifications, validation documentation, or perform validation.
• Ensure that optimal relationships are developed with internal customers/colleagues and with new or existing strategic partners/vendors

Requirements:

• Experience as lead CDM managing studies from start-up through close-out (including data management activities related to study conduct, study completion and archiving of study materials)
• Experience in a pharmaceutical/biologics/biotechnology company must include management or oversight of outsourced CDM activities
• Comprehensive understanding of DM responsibilities and project activities (i.e. budget, timelines, resources) and of linkages with tasks and responsibilities of other functions
• Capable of prioritizing individual and CRO/Vendor tasks based on timelines and study needs
• Ability to use metrics to determine project status, monitor internal/external DM team progress, plan for project resources, and monitor project budget
• Ability to communicate data management standards, developments, and challenges in an accurate, concise, consistent, organized, and grammatically/situationally correct manner to both internal and external audiences
• Ability to propose areas for development or process improvement and assist with staff compliance
• A demonstrated proficiency in efficient database and Medidata Rave
• Familiarity with ICH GCP as well as full knowledge of industry practices and standards (CDISC, SDTM, CDASH)
• Excellent written and oral communication skills