Contract - Senior Clinical Trial AssociateCambridge, MA

Contract - Senior Clinical Trial Associate

Title: Contract - Senior Clinical Trial Associate

Location: Cambridge, MA, Hybrid, or Remote

Reports to: Head of Clinical Operations / Clinical Operations Program Lead

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, in a Phase 3 trial 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 Senior Clinical Trial Associate is a key member of the Clinical Operations and clinical project teams. The Sr. CTA acts as a central contact and hub for the clinical study team and in this capacity supports the team in the planning, implementation, completion, and wind down of clinical trial(s). This individual will work and partner with both internal and external stakeholders, namely investigative sites, vendors, and team members.

Here's What You'll Do:

• Set up, maintain, reconcile, and archive electronic and paper Trial Master Files
• Coordinate TMF transfer with CROs
• Assist with auditing and reconciling all study-related documents for clinical studies
• Work closely with the Study Team Leader and coordinate, track, and manage logistics in support of studies
• Track study status, enrollment, regulatory documentation, laboratory samples, and site start-up status for assigned clinical projects
• Actively order and maintain ancillary clinical study supplies required for the conduct of clinical studies
• Help in planning, preparing, and distributing materials for study meetings
• Prepare agenda and meeting minutes for internal and external meetings as requested
• Assist Study Team Leader with reporting benchmark metrics to senior management
• Contribute to the preparation of presentations and reports as required
• Assist with archiving of study documents for completed clinical studies
• Perform additional tasks as requested

Requirements:

• Bachelor's degree
• 5+ years of relevant hands-on study experience in clinical research, ideally within a sponsor setting
• Exceptional communication (oral and written), organizational, and problem-solving skills
• Excellent Microsoft Office skills
• High-energy individual able to effectively multi-task and strive in a dynamic start-up environment
• Strong attention to detail
• Solid knowledge of GCP guidelines and other regulatory requirements for clinical trial management

Our Vision:

Pioneering microbiome therapeutics by using Defined Bacterial Consortia to transform the lives of patients with serious diseases

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.