Associate Clinical Trial Manager (Temporary)
About The Position
4DMT seeks a motivated and experienced Associate Clinical Trial Manager to support the Company's clinical trial activities. This position will be responsible for supporting the day-to-day operations of one Phase 3 clinical trials including trial conduct and close-out activities. This role requires strong, professional written and verbal communication skills, good organization and attention to detail, and the ability to consistently provide high quality work while managing competing priorities and maintaining tight timelines. This person must be interested in working in a fast-paced, team-oriented environment and be willing to work beyond their job scope to achieve department and company objectives.
Requirements
- A./B.S. degree required
- At least 5 years of work experience supporting clinical trials
- Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements
- Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, SharePoint and Outlook
- Ability to prioritize and manage competing priorities
- Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
Responsibilities
- Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Management
- Collect, track and conduct initial review for completeness of site regulatory documents and/or TMF filing
- Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF)
- Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking
- Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers
- Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance
- Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations
- Communicate directly with sites handling triages, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with study conduct, and/or close-out activities
- Assist with tracking of clinical trial progress including status update reports, as requested
- Assist with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking
- Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM, specific meetings or management updates
- May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues
- Other duties as may be assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
