Associate Director, Clinical Operations - Celerion
Lincoln, NE 68502
About the Job
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
Responsible for operation, management and conduct of clinical studies. Ensure compliance, quality, and profitability.
Essential Functions
- Responsible for staff management in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees.
- Overall management of clinical studies
- On-time performance with defect-free execution
- Work with Clinical Support Coordinator, study design and recruiting to schedule studies
- Set up study initiation meetings to plan execution of study
- Conduct study review meetings for pre-study, in-process and post-study review
- Problem solve as needed during study conduct
- Meet with clients as needed throughout study
- Organize study logistics and personnel
- Be present at critical events and dosings of study
- Ensure profitability
- Maintain profitability of team through budgeting and expense control on a total and individual study basis
- Monitor overtime
- Coordinate with purchasing to ensure expense control
- Staff management/study preparation
- Interpret and implement study specification sheet
- Manage/supervise associates during study conduct
- Assign duties to clinic staff
- Assess and take action as special situations occur in study conduct
- Ensure timely and accurate data is collected
- Ensure compliance and quality
- Ensure compliance with client protocol, Standard Operating Procedures and federal regulations
- Respond to Quality Assurance audits in timely manner
- Implement monthly meetings to review management reports
- Build relationships with community
- Identify physician resources
- Enhance marketing and recruiting
- Provide client services to consumer product and clients
- Assume responsibility for facility management
- Fees
- New business opportunities
- Develop opportunities for computerization of alternative methods of data entry
- Identify additional training requirements (outpatient) for Clinical Research Tech training manuals
Knowledge/ Skills/ Education/ License
- Bachelor's degree in Business, Science or health-related field or BSN
- Proven organizational skills
- Ability to manage multiple priorities
- Excellent oral and written communication skills
- Knowledge of medical terminology preferred
- Ability to work without close supervision
- Ability to work hours required for study conduct
- Level based on years of experience in medical, pharmaceutical or related field of operations
- Ability to work flexible schedule
Celerion Values: Integrity Trust Teamwork Respect
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
PI251162270
Source : Celerion
