Clinical Study Manager

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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.



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