Title: Sr. Clinical Data Manager

Location: Cambridge, MA / Remote / Hybrid

Reports to: Vice President, Head of Clinical Operations

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

Why join Vedanta Biosciences

Vedanta is pioneering the development of a new class of therapies that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field. Vedanta was founded by PureTech Health and a team of world-renowned experts in immunology and microbiology. 

We invite you to explore our site to learn more about our company and how our discovery platform enables identification of bacterial consortia with drug-like properties and their manufacture to GMP standards.

Our Vision:

We are harnessing the human microbiome to enable a new drug modality based on rationally defined bacterial consortia

Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.