Clinical Study Manager
79 TW Alexander Drive RTP, NC 22709 US
Provides guidance and oversight to internal and external project team members for the successful management of all aspects study operation management in accordance with GCP/ICH Guidelines, applicable regulatory requirements, company SOPs, and study protocols.
- Prepares key reports on study progress and assists in delegated clinical study management responsibilities.
- Tracks and assists in the development of study specific timelines, including management and mitigation of deliverables.
- Serves as contact for interacting with and conveying study information to data management, safety, regulatory personnel, and other functional or departmental groups, as necessary.
- Contributes to the identification of risks and opportunities (including contingency and mitigation plans) for the clinical risks and opportunities registry.
- Provides clinical input in the development of case report forms, data management plan, and data listings review.
- Participates in vendor selection and contributes to the RFP process.
- Provides input for site, study and/or vendor specific budgets, as needed.
- Leads meetings with CROs, vendors, and multi-functional teams on a day-to-day basis to ensure quality, on budget and timeliness of deliverables, as necessary.
- Reviews site invoices to ensure that clinical expenses are in accordance with work conducted.
- Assists in evaluation of vendor performance to ensure early mitigation/resolution of potential issues and serves in key role to develop/implement corrective action plans as appropriate.
- Coordinates training of CRO staff, vendors, investigators, and study coordinators on study requirements and SOPs.
- Resolves escalated study conduct issues and provides clinical responses to questions from study centers and institutional review boards/ethics committees.
- Reviews escalated issues from CRAs to ensure adequate mitigation plans are implemented (e.g., investigational site monitoring and/or site audit report findings).
- Drafts, reviews and approves relevant documents, including informed consent, site worksheets, vendor site manuals (pharmacy, lab), monitoring reports.
- Ensures responses to site audits are adequately managed by designated clinical staff.
- Oversees integrity of clinical data to ensure data meets GCP standards, including identification of trends reported from vendors and via review of study data.
- Provides oversight of CTMS tracking to support evaluation and continual management of clinical study set-up and follow-up study activities, as needed.
- Monitors adherence to the regulatory/essential document collection process and release of clinical supplies.
- Assists in the planning and coordination of investigator meetings, as necessary.
- Provides assistance in the management of the trial master file process, including ongoing maintenance, accurate filing and administration of quality control (QC) plan.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.