Principal Investigator

The Clinical Research Manager plays a pivotal role in leading and overseeing clinical trials and research studies, ensuring timely completion and compliance with regulatory standards.

As a senior member of the research team, you will be responsible for managing clinical research projects from start to finish, coordinating and overseeing the execution of clinical trials, and ensuring adherence to protocols, timelines, and budgets.

You will ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards. This includes providing oversight on the recruitment, enrolment, and monitoring of clinical trial subjects, as well as managing relationships with clinical research organizations (CROs), investigators, and external vendors.

Key Responsibilities:

1. Plan, initiate, and manage clinical research projects from start to finish
2. Coordinate and oversee the execution of clinical trials, ensuring adherence to protocols, timelines, and budgets
3. Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards
4. Manage relationships with clinical research organizations (CROs), investigators, and external vendors
5. Lead and mentor clinical research staff, ensuring they are trained and performing effectively
6. Develop training programs and provide ongoing professional development for research teams
7. Oversee the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications
8. Monitor compliance with federal, state, and local regulations, as well as company policies
9. Ensure timely reporting of adverse events and ensure the study meets ethical and regulatory standards
10. Work with scientific and medical teams to develop clinical trial protocols
11. Evaluate feasibility and risk of proposed studies
12. Ensure data collection, monitoring, and analysis are conducted efficiently and accurately
13. Review and analyze clinical trial data to ensure quality and integrity
14. Prepare and present progress reports to senior leadership and stakeholders
15. Develop and manage project budgets, ensuring that clinical trials are completed within financial constraints
16. Oversee resource allocation, including personnel, equipment, and materials
17. Foster communication between internal teams, external partners, and key stakeholders
18. Collaborate with clinical research coordinators, data managers, and other departments to ensure effective study execution

Qualifications:

Education: Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred)

Experience: 8-18 years of experience in clinical research, with at least 2-3 years in a managerial or supervisory role

Skills: Strong project management, leadership, and organizational skills. Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders. Proficiency in clinical research software and data management systems. Strong problem-solving and decision-making abilities