Clinical Lead
Location: United States
Time Type: Full-time
Posted: 2 Days Ago
Job Requisition ID: JR 6635
About ProPharma Group:
ProPharma Group has been a leader in healthcare for over 20 years, providing expert consulting services across the complete product lifecycle. They help biotech, medical device, and pharmaceutical companies navigate their most high-profile drug and device programs. As the largest Research Consulting Organization (RCO), ProPharma offers end-to-end customizable solutions with deep expertise in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, and more.
Position Overview:
The Clinical Lead will be responsible for managing assigned clinical trials, focusing on investigator site management and monitoring activities. This position ensures that clinical trials are conducted in accordance with regulations, generating data that meets regulatory approval standards. The Clinical Lead will provide strategic oversight and support during the startup, execution, and closeout phases of clinical trials.
Essential Functions:
Site Management & Monitoring:
Oversee investigator site management and clinical monitoring teams during study phases.
Lead site management activities for clients, investigational sites, and the internal study team.
Ensure all monitoring activities are compliant with study plans, SOPs, ICH/GCP guidelines, and applicable regulations.
Study Specific Tasks:
Develop and support study-specific training materials and provide training to clinical monitoring teams.
Conduct quality co-monitoring visits to optimize performance and ensure data quality.
Review and approve study monitor site visit reports and maintain communication with project managers and cross-functional teams.
Support site performance-related requirements such as patient recruitment, site payments, and study materials.
Team Collaboration:
Provide timely and effective communication with team members and site personnel.
Ensure coordination with project management teams to report study progress, including initiation, enrollment, and completion.
Supervise and mentor direct reports (e.g., Clinical Research Associates, CRAs) if applicable.
Necessary Skills & Abilities:
Experience:
At least 5 years in clinical research, with previous experience as a CRA.
Prior experience as a Clinical Lead or Lead CRA is preferred.
Significant experience in oncology therapeutic indications is highly desired.
Leadership:
Proven ability to lead clinical operations teams and manage the successful execution of clinical trials.
Strong skills in developing relationships with study site personnel to achieve study goals.
Experience mentoring and developing junior staff members.
Technical Skills:
Familiarity with eTMF, CTMS, EDC, DCT systems.
Strong proficiency in Microsoft Office (Word, Excel, PowerPoint).
Communication:
Excellent verbal and written communication skills with the ability to present and facilitate discussions.
Educational Requirements:
Preferred: Bachelor’s degree. Equivalent experience and training will also be considered.
Why ProPharma?
ProPharma celebrates diversity and fosters an inclusive workplace, empowering employees to innovate and collaborate. As an Equal Opportunity Employer, they provide a safe and supportive environment for all employees to succeed.
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