Associate Director, Clinical Operations
Posted on Feb 20, 2019 by Chondrial Therapeutics, Inc.
# of Openings 1
This position will be responsible for the execution and reporting of clinical trial activities, ensuring adherence to study timelines, budgets, quality plans, and relevant ICH/GCP Guidelines. This position will report to the Vice President, Clinical Operations
- B.A./B.S. (advanced degree preferred) in life sciences or healthcare
- Minimum 7 years of relevant drug development experience in the pharmaceutical/biotechnology industry
- Phase 1 through 3 clinical trial experience
- Experience in rare diseases, oncology, or neuroscience drug development preferred
- Ability to partner with Patient Advocacy Groups
- Thorough knowledge of ICH/GCP guidelines clinical trial design, and regulatory processes
- Demonstrated vendor and project management experience
- Ability to apply analytical and problem-solving skills in the identification of emerging risks and to collaboratively champion solutions
- Proven ability to work with minimal supervision in a cross-functional matrix environment
- Demonstrate the ability to lead and influence others and work successfully in a matrix environment with internal and external team members
- Must be highly organized and detail-oriented
- Must be computer literate
- Some travel required
Chondrial Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.
- Writes and/or reviews protocols, protocol amendments, informed consent forms, annual reports, and submission documents.
- Participates in the development of outsourcing strategies, including the evaluation and selection of CRO's and vendors.
- Manages/monitors clinical study activities and execution by the CRO's/vendors through adherence to study timelines and established metrics.
- Participates in the review and/or generation of all relevant study documents, tools, plans, guidelines, and specifications, including but not limited to EDC, monitoring plans, study management and oversight plans, IWRS specifications, etc.
- Understands and tracks study monitoring/management metrics and understands core concepts of Risk Based Monitoring.
- Development and management of clinical trial finances including study budgets, service contracts, investigator grants, accruals, and forecasting.
- Accountable for ensuring that all studies are carried out according to the study protocol, SOPs, applicable ICH/GCP guidelines,
- Participates in inspection readiness activities and audit activities; works with the quality department to ensure that all corrective and preventative actions are implemented.
- Participates in quality and process improvement initiatives as necessary