Celerion
Clinical Study Manager
Celerion, Tempe, Arizona, us, 85285
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.
Essential Functions
Management of Clinical StudiesOn-time performance with defect-free executionIndependently conduct simple studies such as bioequivalency and bioavailability studiesWith supervision, may assist on complex studiesWork 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 studyConduct study review meetings for pre-study, in-process and post study reviewProblem solve as needed during study conductMeet with clients as needed throughout studyOrganize study logistics and personnelBe present at critical events and dosings of studyBuilds client relationships that result in additional businessCreate and edit reportsRespond to client issues, concerns and requestsAdhere to milestone guidelines
Ensure profitabilityMaintain profitability of team through a budgeting and expense control on a total and individual study basisCoordinate with Purchasing to ensure expense control
Study PreparationInterpret and implement study specification sheetSupervise associates during study conductAssign duties to clinic staffAssess and take action as special situations occur in study conductEnsure timely and accurate data is collected
Ensure compliance and qualityEnsure compliance with client protocol, Standard Operating Procedures and federal regulationsRespond to Quality Assurance audits in timely mannerRespond to data management edit checks
May be 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
Schedule: Monday - Friday 8 AM - 5 PM, flexibility required w/ some remote capability
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Knowledge/ Skills/ Education/ Licenses
Bachelor's degree in a related field or BSN required.Industry experience preferred.Proven organization skillsAbility to manage multiple prioritiesExcellent oral and written communication skillsKnowledge of medical terminology preferredAbility to work without close supervisionAbility to work hours required for study conductStrong customer service skillsPlanning and scheduling skillsProven 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.
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.
Essential Functions
Management of Clinical StudiesOn-time performance with defect-free executionIndependently conduct simple studies such as bioequivalency and bioavailability studiesWith supervision, may assist on complex studiesWork 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 studyConduct study review meetings for pre-study, in-process and post study reviewProblem solve as needed during study conductMeet with clients as needed throughout studyOrganize study logistics and personnelBe present at critical events and dosings of studyBuilds client relationships that result in additional businessCreate and edit reportsRespond to client issues, concerns and requestsAdhere to milestone guidelines
Ensure profitabilityMaintain profitability of team through a budgeting and expense control on a total and individual study basisCoordinate with Purchasing to ensure expense control
Study PreparationInterpret and implement study specification sheetSupervise associates during study conductAssign duties to clinic staffAssess and take action as special situations occur in study conductEnsure timely and accurate data is collected
Ensure compliance and qualityEnsure compliance with client protocol, Standard Operating Procedures and federal regulationsRespond to Quality Assurance audits in timely mannerRespond to data management edit checks
May be 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
Schedule: Monday - Friday 8 AM - 5 PM, flexibility required w/ some remote capability
>
Knowledge/ Skills/ Education/ Licenses
Bachelor's degree in a related field or BSN required.Industry experience preferred.Proven organization skillsAbility to manage multiple prioritiesExcellent oral and written communication skillsKnowledge of medical terminology preferredAbility to work without close supervisionAbility to work hours required for study conductStrong customer service skillsPlanning and scheduling skillsProven 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.