
Clinical Research Director
3 days ago
We are seeking a highly skilled Clinical Research Director to oversee the planning, execution, and management of clinical trials.
About the Role:
- Develop and implement strategies to ensure timely completion of clinical research projects.
- Lead cross-functional teams in the planning, initiation, and conduct of clinical trials.
- Maintain compliance with Good Clinical Practice (GCP) regulations and company policies.
- Provide oversight on data collection, monitoring, and analysis.
- Foster collaboration with internal stakeholders and external partners.
Responsibilities:
- Clinical Trial Management:
- Develop and execute project plans, including timelines and budgets.
- Coordinate with research teams, vendors, and external partners to achieve project objectives.
- Evaluate and improve clinical trial processes and procedures.
- Lead and mentor research staff to enhance their skills and performance.
- Assign tasks and responsibilities based on project needs and team member expertise.
- Ensure adherence to GCP, regulatory requirements, and company policies.
- Monitor and report adverse events and protocol deviations.
- Oversee data collection, monitoring, and analysis to ensure quality and integrity.
- Prepare and present progress reports to senior leadership and stakeholders.
- Develop and manage project budgets, ensuring fiscal responsibility.
- Oversee resource allocation, including personnel, equipment, and materials.
- Facilitate communication between internal teams, external partners, and key stakeholders.
- Resolve issues related to clinical trial execution and provide solutions.
Qualifications:
- Education:
- Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred).
- Experience:
- 8 to 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.
- Certifications:
- Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred (or equivalent).
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