Vedanta Biosciences, Inc.→
Contract - Senior Clinical Trial Associate at Vedanta… · Boston
Skills
Job Description
Title: Contract - Senior Clinical Trial Associate
Location: Cambridge, MA, Hybrid, or Remote
Reports to: Head of Clinical Operations
About Vedanta Biosciences:
Vedanta Biosciencesis a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets include potential first-in-class oral therapy, VE303, in a Phase 3 trial for recurrent C. difficile infection. 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 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.
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 study documents for completed clinical studies
Perform additional tasks as requested
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
The base pay range for this position is expected to be $48-55 hourly; however, the base pay offered may vary depending on market dynamics, experience, internal equity, and job-related knowledge, skills, and capabilities.
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.