Clinical Operations Director
6 days ago
CPC is seeking an experienced Associate Director, Clinical Operations to provide strategic leadership and oversee clinical operations teams.
This is a unique opportunity for a self-driven leader who can promote team effort and accountability, respond quickly to unexpected changes, and make sound decisions.
The successful candidate will be responsible for providing oversight, management, and leadership of Clinical Operations (Project Management) and Trial Master File Management. They will also supervise, coach, and mentor team members reporting to this position, develop and maintain long-term professional relationships with sponsors and vendors, and oversee quality, accuracy, and timeliness of deliverables.
Key Responsibilities:
- Provide strategic input into innovations and contribute to the achievement of functional area goals
- Develop and review/approve applicable Clinical Operations policies, Standard Operating Procedures, and Work Instructions
- Oversee compliance with applicable regulations and guidelines
- Function as an Executive Clinical Operations Manager for assigned projects
- Assist Business Development with benchmarking for budgets and development of proposals and service agreements
Requirements:
- Nursing or BA/BS in a scientific field preferred but not required
- A minimum of 7 years of experience in clinical trials or equivalent experience
- A minimum of 1 year of supervisory experience
- Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations
- Excellent interpersonal communication skills, good problem-solving and organizational skills, and great attention to detail
- Experience with MS Office including Project, Access, PowerPoint, SharePoint, Word, and Excel
- Ability to work as a member of a team and to organize, instruct, and supervise staff
Estimated Salary Range: $107,000 - $130,000 annually
About CPCCPC is an academic research organization that offers full-service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in various therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in various indications, with an emphasis on cardiovascular, wound healing, diabetes, and more.
CPC has expertise in managing clinical trials from various funding sources, including Industry, NIH, and Investigator-Initiated trials. The company's Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered, and healthy.
CPC offers a comprehensive benefits package, matching 401(k) plan, paid holidays, vacation days, paid sick time, in-suite exercise and relaxation room, monthly fun events, and flexible remote work schedules available for certain positions.
An Equal Opportunity Employer, CPC provides equal employment opportunities to all employees and applicants for employment without regard to race, sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over, or any other status protected by applicable federal, state, or local law.
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