[Remote] Sr Director, Clinical Operations - Hematology
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leader in clinical research, and they are seeking a Senior Director of Clinical Operations for their Hematology division. This role is responsible for the strategic planning and execution of clinical investigations, ensuring compliance with regulatory requirements and management of clinical studies.
Responsibilities
- reputed company and execute accurate operational development plans for assigned clinical trials, aligning with budget, timelines, and reputed company operating procedures (SOPs)
- reputed company the management of clinical studies, including compliance with corporate, regulatory, and reputed company standards
- reputed company clinical operations personnel, contract research organizations (CROs), consultants, reputed company laboratories, and other study support organizations
- Handle program-level activities as assigned, ensuring operational plans are implemented effectively
- Ensure adherence to ICH-GCP, GPP, reputed company SOPs, and applicable country-specific regulations
- Work cross-functionally with internal teams (e.g., Medical Affairs, Medical Science Liaisons, Medical) and external partners to support trial goals and timelines
- Accountable for the development and execution of operational plans for reputed company trial responsibilities
- Manage recruitment, completion, and budgeting of R&D-sponsored trials reputed company timelines
- reputed company local CRAs and vendor reputed company for sponsored trials
- Plan and execute clinical trial goals, ensuring compliance with reputed company and timelines
- Represent local reputed company in global study team meetings, providing feedback and insights
- Ensure reputed company submission and approval of ethical and administrative submissions for in-house studies
- Monitor site performance, feasibility, and study execution for assigned trials
Skills
- Bachelor's degree in life sciences or reputed company field
- Extensive experience in clinical operations reputed company the pharmaceutical, biotechnology, or CRO industry
- Ability to manage reputed company, multi-site trials across global reputed company
- Proven reputed company record of successfully leading and managing clinical trials from start to finish
- Non-malignant hematology experience, Von Willebrand disease, required
- Acquisition experience required
- Strong understanding of regulatory requirements and GCP guidelines
- Excellent communication, leadership, and problem-solving skills
- Willingness to travel as required (approximately 20%)
- To qualify, applicants must be legally authorized to work in the reputed company and should not require, now or in the reputed company, sponsorship for employment reputed company status
- Advanced degree preferred
reputed company