DESCRIPTION
Vega Therapeutics is a clinical stage biotechnology company developing novel therapies for rare blood disorders,starting with von Willebrand disease. Founded by former True North executives, Vega has built a team with significant scientific, clinical/ regulatory, and commercial experience that has a demonstrated track record of success in discovering and developing novel medicines for patients with rare diseases. We pride ourselves on our collective passion to bring innovative therapies to the clinic and are committed to patients for whom no or limited treatment options exist.
Vega has is backed by top-tier biotech investors, including Westlake Village Biopartners, Orbimed, New Leaf Venture, Redmile Group, RA Capital, Cormorant Asset Management and Cowen Healthcare Investments.
POSITION SUMMARY
We are seeking a Clinical Trial Manager to join the Clinical Operations team. This individual will be responsible for leading, assisting and providing operational support with the coordination of all aspects related to clinical trial conduct including study start-up, enrollment, maintenance and close-out.
This is a new position that will report to the Director, Clinical Operations and will assist in the overall management of assigned studies.
RESPONSIBLITIES
· Lead or support assigned clinical trial(s) start-up, ongoing activities, close-out and reporting
· Lead or support both internal and external/CRO trial management team, to ensure successful study conduct in accordance with internal SOPs and guidelines, FDA and EMEA regulations, and ICH GCP
· Partner with CROs, other vendors, and internal cross functional groups to drive timelines and study deliverables
· Contribute to vendor selection and management including issue escalation
· May be asked to contribute to the development of departmental processes and SOPs
· Assist with the development and review of study-related and essential clinical study start-up documents (e.g., clinical protocols, patient informed consent documents, investigator brochures, pharmacy manual, project management and clinical monitoring plans, central laboratory manual, Case Report Form (CRFs), and other relevant study plans and charters).
· Responsible for oversight of study vendors for assigned studie(s)
· Sponsor representative in interactions with investigational study sites
SKILLS & ABILITIES
· Excellent planning, organizing, problem-solving and execution skills with the ability to multi-task and prioritize
· Proficiency in MS Word, Excel and Powerpoint
· Excellent interpersonal, verbal and written communication skills
· Ability to travel – domestic and international
EDUCATION & PROFESSIONAL EXPERIENCE
· B.S. in Life Sciences or minimum of 5 years of clinical trial management experience
· Experience in the conduct of Phase 1-3 clinical trials required
· Experience in the conduct of trials in rare diseases preferred
· Experience managing clinical research vendors
· Global clinical development experience preferred
· Working knowledge of ICH GCP