Under direct supervision of the Clinical Operations Program Lead, the CTM is responsible for managing clinical research organization (CRO) clinical/site management activities in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and Vedanta standard operating procedures (SOPs) to the most rigorous standards of quality, timely delivery and within budget. The CTM will lead the day-to-day clinical operations of clinical study.
Here’s What You’ll Do:
- Be responsible for the management of clinical studies, assure adherence to timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP and ICH guidelines.
- Manage study vendors and serve as primary contact for CRO and vendor personnel
- Facilitate internal cross functional team meetings to ensure proper execution and delivery of study milestones.
- Develop training materials and study tools for sites and CRAs
- May provide study specific training to vendors, CRAs, and site staff.
- Liaise with Investigators and/or Study Coordinators participating in the trial as required to ensure optimal sponsor-site relationship and that monitors are meeting expectations.
- Develop and monitor metrics to evaluate monitor and site performance. If performance concerns arise, evaluate cause, and mitigate risk to study.
- Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring.
- Ensure study and site adherence to GCPs, SOPs and study protocols.
- Develop and/or review study documents such as the Protocol, CMP, Study Operations Manual, Source Data Verification Plan, Electronic Case Report Form Completion Guidelines (CCGs), Laboratory Manual, Safety Management Plan, and Informed Consents.
- Participate in CRF development and user testing for EDC.
- Review site Informed Consent forms and site-related materials as needed.
- Review and ensure data is provided by the site in compliance with the Monitoring Plan, CCGs, and Data Management Plan.
- Provide oversight for the setup, maintenance, and close out of the Trial Master File and ensure it is complete and inspection-ready.
- Proactively work to identify, address, resolve, and communicate all ongoing investigational site issues in conjunction with the project team;
- Provide sponsor oversight on site monitoring ensure compliance to ICH/GCP guidelines, study protocol, Monitoring Plan, and Vedanta Standard Operating Procedures.
- Coordinate with the Vedanta Legal Department to draft investigator agreements and contracts.
About Vedanta Biosciences, Inc.
- Bachelor’s-level degree required. Degree in science/health-related field preferred.
- Working knowledge of drug development, GCP, ICH guidelines, and FDA regulations
- 3 or more years of relevant experience in a pharmaceutical/biotech company, CRO, equivalent clinical research; experience with oversight of clinical trial execution, including clinical monitoring and managing clinical trial budgets desirable
- Excellent written and verbal communication skills (including presentation skills)
- Ability to thrive both as an individual contributor and in a team setting
- Strong leadership, interpersonal, organizational, problem-solving, and multi-tasking skills
- Comfortable working with senior management and with team members with varying levels of experience and skill
- Sense of urgency, adaptable in the face of emerging data, innovative/entrepreneurial spirit
- Detail-oriented, solution-oriented
- Diligent about ensuring safety of patients and quality of study data
- Flexibility to take on other duties as assigned
Vedanta is pioneering the development of a new class of therapies based on defined bacterial consortia 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.
We believe that in the near future, doctors will have an entirely new option to treat patients: bacterial consortia therapeutics. We are enabling this new drug class with groundbreaking and industry-leading scientific work powered by large-scale capabilities to identify, screen, and manufacture bacteria with drug-like properties. Our team is at the core of all we do - and we're excited to meet new team members!
About Us, About You
At Vedanta, we value diversity in all its forms and are looking for candidates with a wide variety of perspectives, backgrounds, education, and experiences. We believe that a diverse and inclusive workforce builds the strongest team possible.
We're proud of our workplace culture. Our Vedanta Values inspire us to be the best professionals and colleagues possible. Our values are:
Respect - Collaboration - Execution - Effective Communication - Problem Solving - Scientific Thoroughness