- Supports the Clinical Operations Directors to track and manage tasks delegated
- Review site visit reports, under the direction of the Clinical Operation Directors
- Initiates, reviews, and reconciles study files in the Trial Master File internal and with CROs
- Maintains accurate tracking and reporting of study metrics to support the conduct of clinical trial from start-up to close-out.
- Manages and tracks study samples and supplies
- Assist in the development and review study documents (e.g., site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (e.g., site-specific informed consent forms)
- Coordinate communication of tracking information within the study team and to the clinical sites
- Attend departmental and study-specific meetings
- Take minutes during meetings
- Assist in editing slide presentations, graphs, etc.
- Develop and review Standard Operating Procedures
- May be responsible for the following activities:
- Manage study vendors
- Assist with study-specific training of CRO staff
- Coordinate investigational product release activities across clinical sites
- Manage and track study-specific payments
- Assists in the preparation of Investigator and Study Coordinator Meetings
- University/college degree in health care or other scientifically related discipline is required. Bachelor's degree is preferred
- 5 plus years of experience with 3 or more years of experience in a in clinical operation, study coordinator, data management, site monitoring and/or nursing experience preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility
- Understanding of GCPs and knowledge of regulatory requirements (eg. ICH/CFR guidelines)
- Clear and timely communication of study related status and activities lead to efficient study execution and achievement of key milestones is critical for success in this role
- Proactively identify and resolve/refer project-related operational issues; ability to work independently on routine assignments, or under supervision on new assignments. Ability to handle a moderate volume of highly complex tasks within a given timeline.
- Requires strong organizational skills and ability to prioritize and problem solve.
- Must build relationships across and up and down the organization
- Willingness to travel as necessary, consistent with project needs
- Computer proficiency (Outlook, MS Word, Excel, and PowerPoint)
- Some travel (domestic and international), up to 15%
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Clinical Trial Manager - South San Francisco, United States - The Steely Group
Description
We are seeking a driven and talented individual to join our client's Clinical Operations team as they change the future of oncology. While collaborating with cross-functional departments, you will play a key role in maximizing their technology and progressing their novel therapeutics.
The Clinical Trial Manager (CTM) is responsible for assisting and providing operational support for the Clinical Operations team with the day-to-day activities of executing for one or more clinical trials during the study start-up, maintenance, and close-out periods.
Responsibilities:
Qualifications:
