Clinical Study Manager

TalentBurst, Inc.; North Carolina; On-site; USD 110,000 - 145,000; Full time

Job summary

TalentBurst, Inc. in Durham, NC seeks a Contract Clinical Study Manager to provide operational leadership for assigned studies from start-up through close-out in accordance with ICH/GCP and regulatory requirements.

You will collaborate with internal teams, CROs, vendors, investigators and site personnel to ensure quality deliverables, timelines, and study objectives are met in a dynamic, fast-paced environment.

Qualifications

• Extensive experience in managing clinical trials from start-up to close-out.
• Strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Proven ability to manage CROs, vendors, and cross-functional deliverables.

Responsibilities

• Provide day-to-day study management support from start-up through close-out.
• Coordinate with CROs, vendors, investigators, and site personnel to meet milestones.
• Monitor essential document collection, site activation, and study-specific tracking.
• Lead meetings to review progress, risks, issues, and action items.
• Develop study timelines, deliverables, and mitigation plans for delays.
• Oversee trial master file maintenance and QA activities.

Skills

Clinical trial operations

ICH/GCP guidelines

CRO/vendor management

Cross-functional collaboration

Risk management

Documentation control

Tools

CTMS

Job description

Job Description

Title: Clinical Study Manager
Location: Durham, NC
Duration: 12+ Months

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