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Clinical Study Manager

The Fountain Group LLC

Durham, NC

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JOB DETAILS
SALARY
$56.99–$71.32 Per Hour
SKILLS
Auditing, Billing, Biology, Biostatistics, Budgeting, Case Report Form (CRF), Clinical Data, Clinical Information Systems, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Trial, Communication Skills, Contract Management, Contract Research Organization (CRO), Corrective Action, Cross-Functional, Data Management, Data Quality, Documentation, Electronic Data Capture (EDC), Expense Tracking, GCP (Good Clinical Practices), Health Science, ICH Regulations, Identify Issues, Informed Consent, Interpersonal Skills, Leadership, Maintain Compliance, Medical Products, Microsoft Office, Operations Management, Options Analysis, Organizational Skills, Performance Analysis, Performance Metrics, Pharmacy, Presentation/Verbal Skills, Problem Solving Skills, Progress Reports, Project/Program Coordination, Quality Control, Reconciliation, Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Request for Proposals (RFP), Research Protocols, Staff Training, Standard Operating Procedures (SOP), Startup, Support Documentation, Time Management, Trend Analysis, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Planning, Vendor/Supplier Selection, Writing Skills
LOCATION
Durham, NC
POSTED
2 days ago
Clinical Study Manager
Pay: $56.99 - $71.32 per hour
Durham, NC - hybrid (3 days onsite)
Duration: 1 Year

Job Description:
  • 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.

Primary Responsibilities
• 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.

Required Knowledge, Skills, and Abilities
• Strong knowledge of clinical trial operations, study start-up, maintenance, and close-out activities.
• Strong knowledge of ICH/GCP guidelines, applicable regulatory requirements, clinical study protocols, and company 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.
• Strong verbal, written, organizational, and interpersonal communication skills.
• Ability to manage competing priorities, work independently, and collaborate effectively with internal and external stakeholders.
• Experience using clinical systems and tools such as CTMS, eTMF, EDC, Microsoft Office, and study-specific tracking tools.

Education and Experience
• Bachelor's degree in a life science, health-related, or related field preferred; equivalent directly related experience may be considered.
• 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.
• Experience working with CROs, vendors, clinical sites, and cross-functional study teams is required.
• Experience in sponsor-side study management, vendor oversight, TMF management, audit/inspection readiness, and clinical study documentation is preferred.

What to look for:
  • Bachelor’s degree in a life science, health-related, or related field preferred; equivalent directly related experience may be considered.
  • 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.
  • Experience working with CROs, vendors, clinical sites, and cross-functional study teams is required.
  • Experience in sponsor-side study management, vendor oversight, TMF management, audit/inspection readiness, and clinical study documentation is preferred.
What to update:
  • Strong knowledge of clinical trial operations, study start-up, maintenance, and close-out activities.
  • Strong knowledge of ICH/GCP guidelines, applicable regulatory requirements, clinical study protocols, and company 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
  • Strong verbal, written, organizational, and interpersonal communication skills.
  • Ability to manage competing priorities, work independently, and collaborate effectively with internal and external stakeholders.
  • Experience using clinical systems and tools such as CTMS, eTMF, EDC, Microsoft Office, and study-specific tracking tools.

 

About the Company

T

The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/

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