Company Overview:
HGI Clinical is a clinical research organization committed to advancing healthcare by conducting clinical trials across various therapeutic areas. We are dedicated to delivering innovative solutions and high-quality data to support the development of life-saving treatments. We are looking for a highly motivated and experienced Clinical Project Manager to join our team and provide oversight of a clinical study team and project delivery.
Position Summary:
The Clinical Project Manager will be responsible for overseeing and managing clinical trials from initiation to completion, ensuring compliance with regulatory requirements, company SOPs, and industry standards. This role may be remote on a contract/contract to hire basis.
Key Responsibilities:
- Project Planning and Execution: Develop and manage comprehensive project plans, including timelines, budgets, and resource allocation from study start-up through close-out.
- Team Coordination: Lead cross-functional teams, including clinical operations, data management, and pharmacovigilance.
- Risk Management: Identify potential risks and implement mitigation strategies to ensure project success.
- Regulatory Compliance: Ensure all clinical trials are conducted in accordance with Good Clinical Practice (GCP) and relevant regulatory guidelines.
- Reporting and Documentation: Prepare and present project status reports and performance metrics to senior management and Sponsor.
Qualifications:
- Bachelor’s degree in Life Sciences or related field.
- Minimum of 5 years of experience in clinical project management within a CRO.
- Strong organizational, leadership, and communication skills. Proficiency in project management software and tools.
- Strong knowledge of clinical trial regulations, GCP, ICH guidelines, and regulatory compliance.
- Excellent organizational, problem-solving, and communication skills.
- Ability to work independently and collaboratively in a fast-paced, dynamic environment.
- Experience with clinical trial systems such as electronic Trial Master File (eTMF), electronic data capture (EDC), IRT/IWRS, and other clinical data management tools.
- Familiarity with vendor management and oversight.
Preferred Qualifications:
- Experience working in Phase I-II studies.
- Prefer 2 or more years working in a small to medium CRO environment.
- Knowledge of eClinical technologies and platforms for document management and trial tracking.
- Prefer remote based in (or near) Texas or North Carolina.
How to Apply:
Please submit your resume and cover letter detailing your experience and qualifications to [email protected].