Sign upLog in

Clinical Study Manager

Connexion Systems + Engineering

Durham, NC

Apply
JOB DETAILS
SALARY
SKILLS
Biology, Biostatistics, Budget Management, Budgeting, Clinical Data, Clinical Information Systems, Clinical Monitoring, Clinical Research, Clinical Study Publications, Clinical Trial, Communication Skills, Compensation and Benefits, Contract Research Organization (CRO), Corrective Action, Cross-Functional, Data Management, Data Quality, Documentation, Electronic Data Capture (EDC), File Maintenance, GCP (Good Clinical Practices), Health Science, ICH Regulations, Informed Consent, Leadership, Maintain Compliance, Medical Products, Microsoft Office, Multitasking, Organizational Skills, Performance Analysis, Problem Solving Skills, Project/Program Management, Quality Management, Reconciliation, Regulations, Regulatory Compliance, Regulatory Requirements, Standard Operating Procedures (SOP), Startup, Systems Engineering, Team Player, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Quality Management
LOCATION
Durham, NC
POSTED
10 days ago
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
  • 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!

About the Company

C

Connexion Systems + Engineering

Connexion is an award-winning professional staffing firm that strives to be the unrivaled staffing solution for job seekers by expertly connecting talent with opportunity.  Over the last 20 years Connexion has built the most admired team of staffing experts in the industry.  We give back, change lives and offer unconditional support to the candidates we represent.

Put Connexion's 20 years of experience to work for you! Our professionals have unrivaled relationships and contacts with the hiring managers, human resources team and decision makers at the most desirable companies to work for.

Don't let your resume get lost in an inbox, Connexion's recruiting team will advocate on your behalf to get you the job you want

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1999
WEBSITE
https://www.csetalent.com/

Resume Resources

Free Resume TemplatesFree Resume Builder