Clinical Study Manager
Posted: 07/06/2026
Industry: Scientific and Life Sciences
Job Number: 19291
Security Clearance: NA / not required
Job Description
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Clinical Study Manager
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
Description:
We are seeking an experienced Clinical Study Manager to lead the operational execution of clinical studies from start-up through close-out. This position is responsible for coordinating study activities, managing CROs and vendors, overseeing timelines, and ensuring studies are conducted in compliance with ICH/GCP guidelines, regulatory requirements, and established SOPs.
The ideal candidate is an organized clinical operations professional with strong project management skills and experience working in a sponsor environment.
Responsibilities
Qualifications
Required
Preferred
Ideal Candidate
We're looking for a proactive clinical operations professional who thrives in a collaborative environment and can successfully manage multiple priorities while maintaining compliance, quality, and study timelines. Strong leadership, problem-solving, and communication skills are essential.
Apply today to join a collaborative team supporting the successful execution of impactful clinical research studies.
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly.
You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
Title: Clinical Study Manager
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: 1+ year contract, possible extension
- Pay rate: $56.99–$71.32/hour
- Job Location: Durham, NC
- Schedule: Monday–Friday, 8:00 AM–5:00 PM
- Job#: bh19291
Description:
We are seeking an experienced Clinical Study Manager to lead the operational execution of clinical studies from start-up through close-out. This position is responsible for coordinating study activities, managing CROs and vendors, overseeing timelines, and ensuring studies are conducted in compliance with ICH/GCP guidelines, regulatory requirements, and established SOPs.
The ideal candidate is an organized clinical operations professional with strong project management skills and experience working in a sponsor environment.
Responsibilities
- Manage day-to-day clinical study operations from study start-up through close-out.
- Coordinate activities with cross-functional teams, CROs, vendors, investigators, and clinical sites.
- Track study timelines, milestones, deliverables, and operational risks.
- Lead or support study team, vendor, and CRO meetings.
- Oversee site activation, essential document collection, and clinical supply readiness.
- Monitor vendor and CRO performance while driving issue resolution and corrective actions.
- Coordinate study-specific training for internal and external stakeholders.
- Maintain Trial Master File (TMF) quality, reconciliation, and inspection readiness.
- Review and approve study documentation, including informed consent forms, monitoring plans, laboratory manuals, and other essential study documents.
- Support audit readiness and regulatory compliance throughout the study lifecycle.
- Oversee CTMS reporting and study tracking activities.
- Review clinical data, monitoring reports, and vendor deliverables to support data integrity.
- Collaborate with Data Management, Safety, Regulatory Affairs, Clinical Supplies, Biostatistics, Contracts, and other functional groups.
- Assist with study budgets, vendor scopes of work, invoice review, and financial tracking.
Qualifications
Required
- Bachelor's degree in Life Sciences, Health Sciences, or a related field (or equivalent experience).
- Minimum of 8 years of clinical research experience.
- At least 2 years of Clinical Study Management, Clinical Operations, or related sponsor-side experience.
- Experience managing CROs, vendors, clinical sites, and cross-functional study teams.
- Strong knowledge of:
- ICH/GCP guidelines
- Clinical trial operations
- Regulatory requirements
- Study start-up through close-out activities
- Experience using CTMS, eTMF, EDC, Microsoft Office, and related clinical systems.
- Excellent organizational, communication, and project management skills.
Preferred
- Sponsor-side clinical study management experience.
- Trial Master File (TMF) oversight.
- Audit and inspection readiness experience.
- Vendor oversight and performance management.
- Budget management and financial tracking experience.
Ideal Candidate
We're looking for a proactive clinical operations professional who thrives in a collaborative environment and can successfully manage multiple priorities while maintaining compliance, quality, and study timelines. Strong leadership, problem-solving, and communication skills are essential.
Apply today to join a collaborative team supporting the successful execution of impactful clinical research studies.
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly.
You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
Meet Your Recruiter
Caroline Driscoll
Account Manager & Sr. Technical Recruiter
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Durham, NC
Ready to embark on your next career adventure? Explore our job opportunities in and around Durham, North Carolina, a vibrant city nestled in the heart of the Research Triangle. Known for its booming tech industry, top universities like Duke and UNC Chapel Hill, and a thriving arts scene, Durham offers an inviting blend of Southern charm and innovation. Imagine working just minutes away from the stunning Duke Gardens, catching a show at the Carolina Theatre, or cheering on the Durham Bulls baseball team at the historic Durham Bulls Athletic Park. With its culinary delights, including top-notch BBQ joints and food trucks, along with easy access to outdoor activities at the Eno River State Park, Durham promises a fulfilling work-life balance for those seeking new career opportunities. Explore our listings today and discover why Durham is the perfect place to grow your career.