Clinical Study Manager

Belcan is a global supplier of engineering, technical recruiting, and IT services to customers in the aerospace, defense, industrial, and government sectors. Belcan engineers better outcomes through adaptive and integrated services—from jet engines, airframe, and avionics to heavy vehicles, chemical processing, and cybersecurity, Belcan takes a partnering approach to provide customer-driven solutions that are flexible, scalable, and cost-effective. Belcan’s unique capabilities have led to continuous growth and success for nearly 60 years.

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Clinical Study Manager (Contract)

Pay Rate: $56.99 - $71.32/hr.

Location:

Durham, NC ZIP Code: 27701

Start Date:

Right Away

Shift: 8:00 AM- 5:00 PM

• Provide day-to-day study management support and oversight for assigned clinical study activities from start-up through close-out.
• Coordinate with internal project team members, CROs, vendors, investigators, and study coordinators to support milestone achievement and timely delivery of study activities.
• Monitor adherence to essential document collection processes, site activation requirements, clinical supply release requirements, and study-specific tracking tools.
• Support and/or lead meetings with CROs, vendors, and cross-functional teams to review study progress, risks, issues, action items, and deliverables.
• Track and support development of study-specific timelines, deliverables, and mitigation plans to address study delays or operational risks.
• Assist in vendor selection activities, including contribution to RFPs, scopes of work, vendor budgets, and study/vendor-specific planning documents.
• Evaluate CRO and vendor performance and support early identification, escalation, mitigation, and resolution of potential issues.
• Develop, implement, and follow up on corrective and preventive action plans, as appropriate.
• Coordinate and verify study-specific training for CRO staff, vendors, investigators, study coordinators, and other relevant study team members.
• Support oversight of vendor staff qualification, training, turnover documentation, and ongoing performance against study milestones and KPIs.
• Assist in the management and maintenance of the Trial Master File, including accurate filing, reconciliation, ongoing review, and execution of quality control activities.
• Draft, review, and/or approve study-related documents, including informed consent forms, site worksheets, vendor/site manuals, pharmacy manuals, laboratory manuals, monitoring plans, and monitoring reports, as applicable.
• Review and support responses to site audits, monitoring findings, and other escalated study conduct issues.
• Provide clinical and operational responses to study centers, CROs, vendors, IRBs/ECs, and internal stakeholders, escalating issues when appropriate.
• Ensure study documentation supports inspection readiness and compliance with applicable regulatory requirements, company SOPs, and study protocols.
• Oversee CTMS tracking and study status reporting to support evaluation and management of study set-up, conduct, follow-up, and close-out activities.
• Review clinical data, data listings, vendor reports, monitoring trends, and other study outputs to support data integrity and GCP compliance.
• Provide clinical input into case report forms, data management plans, data transfer plans, and clinical data review activities.
• Collaborate with data management, safety, regulatory, clinical supplies, contracts, biostatistics, and other functional groups to support study execution.
• Prepare key reports on study progress, risks, issues, action items, and delegated clinical study management responsibilities.
• Provide input into study, site, and vendor budgets, as needed.
• Review site and vendor invoices to ensure expenses are consistent with work performed, approved budgets, and study agreements.
• Support investigator budget templates, vendor scopes of work, contract-related inputs, and study financial tracking activities.
• Managers and supervisors may assign other duties as needed.

• Strong knowledge of clinical trial operations, study start-up, maintenance, and close-out activities.
• Strong…