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.
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
New business opportunities
Develop opportunities for computerization of alternative methods of data entry
Identify additional training requirements (outpatient) for Clinical Research Tech training manuals
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
Are you ready to join our team?
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.
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