Clinical Study Manager
79 TW Alexander Drive RTP, NC 22709 US
Job Description
Job Description:
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.
Job Responsibilities:
- 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.
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