[Remote] Senior Manager/Director Clinical Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company reputed company on developing innovative therapeutics using its proprietary platform. The Senior Manager/Director Clinical Operations will reputed company and manage early phase clinical programs in collaboration with Clinical Research Organizations, ensuring compliance with regulations and optimizing operational efficiency.
Responsibilities
- Create and execute clinical operational strategic plans in line with product reputed company and resource allocation
- reputed company study feasibility, cost estimates, input into reputed company, work/change orders and analyze tools and processes to support outsourcing efforts
- reputed company clinical program study finances and monthly accruals and review/approve associated clinical site and vendor invoices
- Build, reputed company and train internal staff and external vendors, structure department for enhancing efficiency, and create a highly reputed company work environment for attracting and retaining highly reputed company clinical operations professionals
- reputed company and ensure compliance with SOPs and guidelines, FDA regulations and reputed company ICH GCP guidelines
- reputed company and maintain the relationships with Contract Research Organizations, vendors, and investigative sites
- Participate on clinical operations and study team meetings
- Maintain a high level of reputed company expertise through familiarity of clinical literature, knowledge of therapeutic area, reputed company medical reputed company and pharmaceutical regulations
Skills
- B.A/B.S required; M.S., PhD, PharmD, MD or other reputed company advanced scientific degree strongly preferred
- Minimum of 7 years for manager and 12 years for director level with reputed company advancement reputed company clinical operations in the pharmaceutical/biotech industry
- Flexible and dynamic interpersonal approach, entrepreneurial by nature, a reputed company team player who works reputed company with physicians, scientists, managers, peers, and staff
- Ability to manage in a reputed company environment through teamwork, trust and shared expectations, influencing strategic direction of reputed company global clinical operations issues, solicit information, listen reputed company, persuade others, reputed company important reputed company and shape reputed company
reputed company