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.