What are the responsibilities and job description for the Clinical Study Manager position at Celerion?
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 management and conduct of clinical studies. Ensure compliance, quality, and profitability of clinical studies. Respond to Client issues, concerns, and requests. Responsible for applying study management techniques and tools in order to meet and/or exceed internal and external client needs.
\n- On-time performance with defect-free execution
- Independently conduct simple studies such as bioequivalency and bioavailability studies
- With supervision, may assist on complex studies
- Work with support divisions to ensure timelines are being met in clinical studies (i.e. recruiting, data management, statistics)
- 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
- Builds client relationships that result in additional business
- Create and edit reports
- Respond to client issues, concerns and requests
- Adhere to milestone guidelines
- Maintain profitability of team through a budgeting and expense control on a total and individual study basis
- Coordinate with Purchasing to ensure expense control
- Interpret and implement study specification sheet
- 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 with client protocol, Standard Operating Procedures and federal regulations
- Respond to Quality Assurance audits in timely manner
- Respond to data management edit checks
- Bachelor’s degree in a related field or BSN required.
- Industry experience preferred.
- Proven organization 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
- Strong customer service skills
- Planning and scheduling skills
- Proven multi-tasking skills
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.
