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Clinical Study Manager
Job Location:
Job Location:
Durham, NC - USA
Hourly Salary:
USD 56 - 71
Hourly Salary:
Posted:
8 September 2026 (17 hours ago)
Posted:
Application Deadline:
6 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Title: Clinical Study Manager
Location: Durham NC
Duration: 12 Months
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
Bachelors 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.
#TBPH
#ZR
Location: Durham NC
Duration: 12 Months
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
Bachelors 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.
#TBPH
#ZR
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We offer competitive compensation and comprehensive benefits including medical dental vision and retirement options.
TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.
Required Experience:
Manager
