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Clinical Study Manager

inSync Staffing

  • Durham, NC
  • 1 day ago
  • $56.99–$71.32 Per Hour

Highlights

The Contract Clinical Study Manager works closely with internal cross-functional teams, CROs, vendors, investigators, and study site personnel to ensure study deliverables are completed with quality, within expected timelines, and in alignment with study objectives. 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.

Numbers & Facts

LocationDurham, NC
IndustryStaffing/Employment Agencies
Salary$56.99–$71.32 Per Hour
Company Size50 to 99 employees
Year Founded2014
Websitehttp://www.insyncstaffing.com/default.html

Description

Job Title: Clinical Study Manager
Location: Durham, NC 27709
Pay Rate: $56.99 - $71.32 / Hour
Work Schedule: Monday - Friday, 8:00 AM - 5:00 PM
Job Overview:
The Contract Clinical Study Manager provides operational leadership, coordination, and oversight for assigned clinical studies. This role supports the successful execution of study activities in accordance with ICH/GCP guidelines, applicable regulatory requirements, company SOPs, study protocols, and study-specific plans. The Contract Clinical Study Manager works closely with internal cross-functional teams, CROs, vendors, investigators, and study site personnel to ensure study deliverables are completed with quality, within expected timelines, and in alignment with study objectives.
Job Specifications:
  • 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 and follow up on CAPA plans as needed.
  • 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 (TMF), including accurate filing, reconciliation, ongoing review, and 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.
  • 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.
  • Ensure study documentation supports inspection readiness and compliance with applicable regulatory requirements, SOPs, and protocols.
  • Oversee CTMS tracking and study status reporting to support evaluation and management of study 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, and review site/vendor invoices to ensure expenses align with work performed and approved agreements.
  • Support investigator budget templates, vendor scopes of work, contract-related inputs, and study financial tracking activities.
Qualifications and Experience:
  • At least eight years of clinical research experience, including at least two years of experience in clinical study management, clinical operations, or related clinical trial roles.
  • Required experience working with CROs, vendors, clinical sites, and cross-functional study teams.
  • Strong knowledge of clinical trial operations, ICH/GCP guidelines, regulatory requirements, clinical study protocols, and SOPs.
  • Demonstrated ability to manage CROs, vendors, study timelines, risks, action items, and cross-functional deliverables.
  • Ability to identify issues, evaluate options, make sound recommendations, and drive timely resolution.
  • Experience using clinical systems and tools such as CTMS, eTMF, EDC, Microsoft Office, and study-specific tracking tools.
  • Preferred: Experience in sponsor-side study management, vendor oversight, TMF management, audit/inspection readiness, and clinical study documentation.
Education Requirements:
  • Bachelor s degree in a life science, health-related, or related field preferred; equivalent directly related experience may be considered.
Benefits (employee contribution):
  • Health insurance
  • Health savings account
  • Dental insurance
  • Vision insurance
  • Flexible spending accounts
  • Life insurance
  • Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.

About Company

We recognize the VMS program management team is our customer and needs to be serviced with integrity, so we built and continue to improve upon our delivery methods as we strive to provide the highest quality service possible. inSync Staffing’s management team recognized ten years ago the inevitable changes to the staffing industry being brought about by technology and the growing trend of Fortune 1000 corporations to outsource management of their contingent workforces to meet compliance and cost control goals. Rather than swim upstream against the changes, inSync Staffing has embraced MSP and VMS programs as our customers, not competitors. We asked program managers how they want to be serviced. The result of their input is that we have structured inSync Staffing as a recruiting and customer service organization, unlike traditional staffing companies who sell directly to the end client. Our delivery model allows us concentrates our resources on how to best supply candidates in a very competitive MSP/VMS program environment.

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