Associate Clinical Trial Manager
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Job Description
Associate Clinical Trial Manager supporting clinical trial activities for a leading biotechnology company. Coordinating trial operations and ensuring compliance in clinical studies.
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 for IP release 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, and sample and investigational product tracking
- Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers
- Receive and review all regulatory documents from sites (direct or through CRO) for accuracy and compliance to applicable SOPs and regulatory guidelines
- Ensure timely updates are provided to CTM for updating of ‘Clinicaltrial.gov’ (site updates/changes)
- Track and route new CDAs, contracts and Work Orders through established legal approval process (CTAs, MSAs, work/task orders)
- Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance
- Assist with the development of site tools and clinical trial start-up activities
- 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
- Assist in tracking of trial IP and development of Pharmacy Manuals
- Participate in study vendor set up and specification process, as appropriate
- Communicate directly with sites, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, 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
- Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation
- 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
- Willing to travel as business needs demand (<5% anticipated)
- Other duties as may be assigned
Requirements:
- A./B.S. degree required
- At least 5 years of work experience supporting clinical trials, with some experience supporting ophthalmology studies (required)
- Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements
- Proficient computer skills, specifically with Microsoft Office Suite that includes 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.
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