Associate Director of Clinical Trial Management
Asc. Director of Clinical Study Management
Associate Director of Clinical Study Management reports to the Director of Clinical Operations. The incumbent will lead the planning, management, and execution of assigned clinical studies, including creating and managing study timelines, budgets, and study management plans. The AD of Clinical Study Management is responsible for managing all aspects of a clinical trial or multiple clinical trials with emphasis on internal team and CRO & vendor management to ensure timeline adherence, patient safety, adherence to contracted deliverables, the protocol(s) and appropriate regulations are adhered to and data integrity/quality performance are met.
- Create, manage, and execute clinical operations programs, including study management, and budget and Gantt timeline creation
- Liaise with clinical site staff and Investigators as appropriate to drive optimal Sponsor-site relationships
- Develop with Study Protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
- Study start-up activities, site initiation and site identification
- Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans) Develop and execute complex study plans and study related documents in one or more clinical studies with minimal supervision.
- Track and report on the progress of assigned clinical trials including enrollment metrics and forecasts, budget and clinical timelines.
- Ensure oversight and compliance of internal external teams to ensure studies are conducted efficiently, effectively and in accordance with the protocol, GCP/ICH guidelines, FDA regulations and applicable SOPs.
- Participate in study data review and interpretation.
- Organize and participate in meetings, i.e., Study Team Meetings & Trainings, Investigator Meetings, and Scientific Meetings.
- Partner with other teams to ensure and drive study management and delivery activities
- Manage all aspects of study progress from initial study planning to study close-out through CSR completion to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines
- Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
- Bachelor degree in a scientific or healthcare discipline preferred with over 7 years’ experience as a study manager/clinical trial manager. Minimum of 5+ years in clinical and drug development in the pharmaceutical/biotech industry
- Must have extensive Oncology experience, monitoring/study management
- Understanding of drug development from pre-IND through NDA
- Extensive experience managing clinical programs, CROs, budgets, and timelines required
- Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required
- Management of CROs, multiple vendors, and complex protocols
- Protocol, ICF, and study document writing experience required
- A detailed understanding of overall strategic direction, interrelationships and business needs
- Proven experience in the execution and oversight of the operational aspects of all stages of clinical studies
- Ability to organize and manage multiple priorities required
- Flexibility to adapt to changing program needs in real time
- Strong leadership skills
- Ability to build strong relationships with co-workers of various backgrounds and expertise
SRG Woolf is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
Clinical Study Reports
Non Disclosure Agreement (Intellectual Property Law)
Good Clinical Practices (Gcp)