Clinical Study Manager

Belcan Corporation; Durham (NC); On-site; USD 77,145 - 97,809; Full time

Job summary

Belcan Corporation in Durham, NC is seeking a Contract Clinical Study Manager to provide operational leadership and oversight for assigned studies, ensuring adherence to ICH/GCP, regulatory requirements, SOPs, and study plans across CROs, vendors, investigators, and sites.

You will coordinate with cross-functional teams, develop timelines, monitor milestones, support budget development, review study documents and audits, and maintain TMF and data integrity to support inspection readiness.

Qualifications

• Bachelor’s degree in life sciences or related field preferred; equivalent directly related experience may be considered.
• At least eight years of clinical research experience, including two years in study management or related roles.
• Experience working with CROs, vendors, clinical sites, and cross-functional teams is required.
• Sponsor-side study management, vendor oversight, TMF management, and audit/inspection readiness preferred.

Responsibilities

• Provide day-to-day study management support for assigned activities from start-up through close-out.
• Coordinate with CROs, vendors, investigators, and study coordinators to support milestone achievement and timely delivery of study activities.
• Monitor adherence to essential document collection, site activation, and study-specific tracking tools.
• Lead meetings with CROs, vendors, and cross-functional teams to review progress, risks, issues, and action items.
• Develop timelines, deliverables, and mitigation plans to address delays or operational risks.
• Assist in vendor selection, including scopes of work, budgets, and planning documents.
• Evaluate CRO and vendor performance and escalate issues as needed.
• Develop corrective and preventive action plans as appropriate.
• Coordinate study training for CRO staff, investigators, and study coordinators.
• Oversee vendor staff qualifications, turnover documentation, and performance against milestones.
• Manage Trial Master File accuracy, filing, reconciliation, and quality control activities.
• Draft/review study documents including informed consent forms and site manuals.
• Support responses to site audits and monitoring findings.
• Ensure compliance with regulatory requirements, SOPs, and study protocols.
• Oversee CTMS tracking and study status reporting for set-up, conduct, and close-out.
• Review data listings, vendor reports, and monitoring trends for data integrity and GCP compliance.
• Provide input into case report forms, data management, and data transfer plans.

Skills

Study management

Regulatory compliance

Vendor management

Cross-functional leadership

Communication

Organization

CTMS familiarity

Education

Bachelor’s degree in life sciences or related field

Tools

CTMS

eTMF

EDC

Microsoft Office

Job description

Job Title: Clinical Study Manager

Pay Rate: $56.99 - $71.32/hr.

Location: Durham, NC

ZIP Code: 27701

Start Date: Right Away

Shift: 8:00 AM- 5:00 PM

Keywords: #ClinicalStudyManagerjobs #Durhamjobs

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.

Equal Employment Opportunity Statement

Belcan is an equal‑opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.