Top 296 Clinical trial manager Jobs in Research Triangle Park Nc

Clinical Study Manager
System One —Durham, NC
- Contract
- Mid-level
- Bachelor's degree
- In-person
- Health insurance
- Dental insurance
Quick Apply
5d
Global Lead Project Manager (FSP), US (remote)
Thermo Fisher Scientific —North Carolina
- Full-time
- Remote
- Microsoft Excel
- Microsoft Outlook
- 3 years
10d
Clinical Project Manager (US)
Alimentiv —Raleigh-Durham, NC
- $95,500 - $159,000 a year
- Full-time
- Remote
- English
- Mid-level
- Bachelor's degree
Quick Apply
Senior Clinical Trial Manager - CNS - U.S. (Remote)
Worldwide Clinical Trials —Research Triangle Park, NC
- $112,000 - $222,000 a year
- Full-time
- Remote
- Nursing
- English
- Bachelor's degree
Global Clinical Operations Leader / Clinical Trial Manager
Parexel —Durham, NC
- Remote
- Nursing
- 5 years
- Continuous improvement
Clinical Trial Manager - CAR T or Ophthalmology
Fortrea —Durham, NC
- $140,000 - $148,000 a year
- Full-time
- Remote
- English
- 3 years
- Master's degree
Clinical Project Manager- IVD
IQVIA —Durham, NC
- $93,100 - $232,800 a year
- Full-time
- Bachelor's degree
- 1 year
- Senior level
3d
Clinical Project Manager, Immuno-Oncology - IQVIA Biotech
IQVIA —Durham, NC
- $93,100 - $232,800 a year
- Full-time
- Customer service
- Bachelor's degree
- Continuous improvement
Senior Clinical Study Manager
Veranex, Inc. —Raleigh, NC
- $125,600 - $179,630 a year
- Full-time
- 5 years
- Bachelor's degree
- Contracts
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Senior Global Clinical Study Manager
IQVIA —Durham, NC
- $93,100 - $232,800 a year
- Full-time
- Customer service
- Bachelor's degree
- Continuous improvement
Manager, Clinical Operations
IQVIA —Durham, NC
- $86,500 - $216,000 a year
- Full-time
- Microsoft Excel
- English
- Mid-level
Clinical Trial Manager
InfoQuest Consulting Group Inc. —Durham, NC
- Email
- Contracts
- Senior level
Experienced Clinical Trial Manager - Full-Service
サイネオス・ヘルス —Morrisville, NC
- $114,000 - $210,900 a year
- Computer literacy
- Bachelor's degree
- Travel
- Employee stock purchase plan
- Health insurance
Clinical Project Manager
Pluto Health —Durham, NC
- $85,000 - $120,000 a year
- Full-time
- 3 years
- Analysis skills
- Senior level
- Paid holidays
- Health insurance
Clinical Trials Manager
Kite Pharma —Raleigh, NC
- $133,195 - $189,640 a year
- Full-time
- 6 years
- Surgery
- RN License
- Health insurance
- Dental insurance
4d
Clinical Project Manager - Oncology (Client Dedicated/Remote)
サイネオス・ヘルス —Morrisville, NC
- $120,000 - $135,000 a year
- Remote
- Mid-level
- 3 years
- Bachelor's degree
- Employee stock purchase plan
- Health insurance
Project Manager - US - Remote
Worldwide Clinical Trials —Durham, NC
- Full-time
- Remote
- 5 years
- English
- Travel
Senior Clinical Data Manager
Fortrea —Durham, NC
- $85,000 - $120,000 a year
- Full-time
- Remote
- Bachelor's degree
- Data entry
- Experience equivalent to degree accepted
- Disability insurance
- Health insurance
2d
Site Activation Manager - Europe/US - Remote
Worldwide Clinical Trials —Durham, NC
- Full-time
- Remote
- Nursing
- Microsoft Excel
- English
Patient Engagement Lead – Global Clinical Trial Recruitment and Retention
サイネオス・ヘルス —Morrisville, NC
- $79,800 - $139,600 a year
- Remote
- Inventory management
- 5 years
- Bachelor's degree

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Clinical Study Manager

System One -
Durham, NC

Quick Apply

Job Details

Contract
5 days ago

Benefits

Health insurance
Dental insurance
401(k)
Vision insurance
Life insurance

Qualifications

Research project management
Document control experience within pharmaceutical industry
Clinical trial risk management
Operational management
Schedule management
ICH guidelines
Managing clinical research teams
Vendor relationship management
Clinical trial standard operating procedures
Productivity software
Clinical quality assurance standards
Cross-functional collaboration
Cross-functional team management
Standard operating procedures (SOPs)
Cross-functional communication

Full Job Description

Job Title: Clinical Study Manager
Location: Durham, North Carolina
Type: 12-month Contract
Work Model: Onsite
Hours: 40.0

Overview

The Clinical Study Manager provides onsite operational oversight for assigned clinical studies from start-up through close-out, ensuring delivery aligns with ICH/GCP, regulatory requirements, and internal SOPs. This role partners with cross-functional teams, CROs/vendors, and study sites to drive timelines, manage risks/issues, and maintain inspection-ready documentation using tools such as CTMS/eTMF/EDC.

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.

Requirements

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.
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 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.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Refine Your Search

clinical trial manager jobs in research triangle park nc

Clinical Study Manager

Global Lead Project Manager (FSP), US (remote)

Clinical Project Manager (US)

Senior Clinical Trial Manager - CNS - U.S. (Remote)

Global Clinical Operations Leader / Clinical Trial Manager

Clinical Trial Manager - CAR T or Ophthalmology

Clinical Project Manager- IVD

Clinical Project Manager, Immuno-Oncology - IQVIA Biotech

Senior Clinical Study Manager

Senior Global Clinical Study Manager

Manager, Clinical Operations

Clinical Trial Manager

Experienced Clinical Trial Manager - Full-Service

Clinical Project Manager

Clinical Trials Manager

Clinical Project Manager - Oncology (Client Dedicated/Remote)

Project Manager - US - Remote

Senior Clinical Data Manager

Site Activation Manager - Europe/US - Remote

Patient Engagement Lead – Global Clinical Trial Recruitment and Retention

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