Title:                   Contract - Senior Clinical Trial Associate

Location:           Cambridge, MA, Hybrid, or Remote

Reports to:        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 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 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 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

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.

Title:                   Contract - Senior Quality Control Specialist

Location:           Cambridge, MA - onsite

Reports to:        Senior Manager, Quality Control

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 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 Role:

This position directly supports Vedanta’s in-house cGMP manufacturing capabilities. This role will be lab-centered and focused on Drug Product and Drug Substance testing for release and stability. In addition to performing testing, this role will participate in the management of the Quality Control laboratory with daily responsibilities including routine lab testing, inventory management, and data reporting.

There will be collaboration with Analytical Development, Quality Assurance, and Production departments to support cGMP manufacturing, Process Validations, and Analytical Testing Validations.

A successful candidate for this role will have strong attention to detail, good organizational skills, and be a quick learner. They will be able to exercise judgment within defined procedures and practices to determine appropriate action and ask questions if the path forward is unclear, follow routine procedures, apply learned techniques, and contribute to analysis and investigation to solve problems. An ideal candidate will be a strong independent worker, able to self-organize and execute day-to-day work autonomously.

Previous experience with hands-on laboratory testing in a microbiology laboratory, aseptic technique, qPCR, pipetting, and general USP microbiological is required. Experience with chemistry testing and data review preferred.

This role will require being on-site full-time in Cambridge.

Here’s What You’ll Do:

• Perform routine microbiology testing to support release and stability of Vedanta products
• Perform testing to support assay validation activities
• Review test lab data, protocols, reports, and quality events (deviations, OOS etc.)
• Author, review, and revise SOPs, protocols, and reports
• Participate in continuous improvement projects to support the growth of the company
• Participate within the QC team to meet group and company goals

Requirements:

• BS in a scientific discipline
• Minimum 5+ years working in a GMP environment and/or Quality Control test lab
• Direct, hands on, experience with PCR/qPCR testing
• Direct experience with aseptic sampling and testing techniques
• Strong laboratory and organizational skills, attention to detail, flexibility, and the ability to work independently and within a team environment
• Experience working within QMS systems, deviation investigations, OOS, CAPAs and Change Controls
• Experience with QC continuous improvement projects; project management skills a plus
• Proficient in Outlook, MS Word, Excel, and lab-based data management systems
• Knowledge of FDA and EU compliance principles
• Knowledge of USP and ICH guidance preferred

The base pay range for this position is expected to be $46-53 per hour; however, the base pay offered may vary depending on market dynamics, experience, internal equity, and job-related knowledge, skills, and capabilities.