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Clinical Research Operations Manager
2 months ago
Position Summary:
The Clinical Research Operations Manager will play a pivotal role in directing and supervising our forthcoming clinical studies. The ideal candidate should possess substantial expertise in monoclonal antibody research, with experience in both domestic and international settings. A background in intensive care unit (ICU) operations and infectious disease studies is highly advantageous.
- Lead the strategic planning, execution, and oversight of clinical research initiatives.
- Ensure adherence to regulatory standards and clinical research protocols.
- Collaborate effectively with multidisciplinary teams, including contract research organizations (CROs), medical professionals, regulatory bodies, and quality assurance teams.
- Manage clinical trial sites, encompassing site selection, initiation, and ongoing monitoring.
- Develop and uphold study timelines, financial plans, and resource allocations.
- Prepare and submit necessary regulatory documentation and reports.
- Guarantee data integrity and quality throughout the research process.
- Foster relationships with external vendors and stakeholders.
- A Bachelor's degree or higher in a relevant discipline.
- Demonstrated experience in clinical research operations, particularly with monoclonal antibody studies.
- Experience in ICU settings and infectious disease research is highly preferred.
- In-depth knowledge of FDA regulations and ICH-GCP guidelines.
- Exceptional project management and organizational capabilities.
- Ability to operate independently and collaboratively in a dynamic environment.
- Strong communication and interpersonal skills.
Mcure Biosciences is an innovative startup focused on advancing clinical research initiatives. We are looking for a seasoned Clinical Research Operations Manager to contribute to our mission.
