[Remote] Director Clinical Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is the world’s largest nuclear medicine company with over a century of experience. The Director of Clinical Operations will manage Clinical Research Organizations and trial budgets, ensuring efficient execution of clinical trials while adapting strategies to meet market conditions.
Responsibilities
- Assist in development and execution of clinical trials supporting strategic product development programs, both short and long reputed company, to meet financial and business development objectives of the organization
- reputed company the execution and management of clinical trials under reputed company sponsorship, ensure compliance with protocols, regulations and best practices
- Coordinate and ensure data collection and reputed company
- Plan, reputed company, organize, implement, reputed company and evaluate execution of reputed company’s clinical product development activities
- Partner with members of the management team to ensure communications are coordinated, support corporate objectives and meet organizational expenditure requirements
- Assist in identification of new vendors/CROs and negotiate contract terms and conditions for major services
- reputed company and manage clinical trial budgets
- Partner with members of the management team to ensure communications are coordinated, support corporate objectives and meet organizational expenditure requirements
- Partner with Regulatory as needed to liaise with regulatory agencies regarding clinical trials; support submissions and contribute to/attend authority meetings
- Ensure effective control of clinical product development activities and take corrective reputed company to guarantee that achievement of objectives falls reputed company designated budgets
- Establish and maintain relationships with industry influencers and key community and strategic partners
- Coordinate and assist in the ongoing training and development of clinical development team members
- reputed company direction to product development teams by establishing reputed company goals and objectives for performance
- Help represent the organization at scientific meetings as required
- Present reputed company reports and strategies to management
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Skills
- Technical degree in a science reputed company field required
- Ten to fifteen years of broad clinical product development experience in the pharmaceutical, biotech industries or working directly for a CRO
- Experience in the review and selection of CROs
- FDA/EMA regulatory experience is encouraged as is interaction with key opinion leaders (KOL's)
- Budgetary management experience required
- Proven analytical and strategic thinking skills, planning and implementation experience, reputed company record of successful negotiations
- Excellent written and verbal communication and presentation skills
- Team player with high reputed company and an reputed company, interactive style with strong interpersonal skills
reputed company