The Clinical Project Manager will manage the overall operation of pre-clinical and clinical trials including project planning, budget, resource management and, if required, contract research organization management CRO .
Provides oversight, supervision, and mentorship to Clinical Operations staff.
ESSENTIAL JOB RESPONSIBILITIES:
Manages clinical operational plan, and incorporates the study and scientific plan
Ensures the selection of qualified clinical trial sites
Develops study related documents and overall direction for the clinical sites to establish protocol development.
Negotiates all aspects of clinical trial agreements Monitors clinical trial sites for compliance and performance
Ensures compliance with good clinical practices GCPs and regulatory guidelines
Recommends and implements innovative process ideas to impact clinical trials management
Manages clinical budget and develops contingency plans for clinical trials
Oversees Operations staff, both regular and contract staff, and manages all aspects of clinical operational plan
Responsible for managing full scope of study
Review the data management and statistical plans and provide input for execution of plan elements
Assure data quality by planning data review and ongoing process control checks
Develop and maintain effective communication across functions, including the Executive, R D, Medical Affairs, Regulatory, Finance and Commercial teams; including regular reporting on adherence to timelines, milestones and budget, with recommendations for plan adjustments as needed
Effectively communicate changing priorities, within the cross-functional and Clinical teams, as studies progress
Complete all assigned and required training satisfactorily and on time.
Education and Experience in years :
Bachelor s degree in a scientific discipline or equivalent experience 5 to 7 years of clinical research experience within medical device IVD preferred , biotech, or pharmaceutical
Knowledge and skills:
Excellent organizational and project management skills Strong leadership skills, self-motivated, adaptable to a dynamic environment Strong oral and written communication skills; strong technical writing skills
Working knowledge of FDA regulatory requirements related to clinical research
Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results
Ability to problem solve and delegate appropriate tasks to team members
Able to collaborate effectively with the study team, cross-functional team members, and external partners Travel requirements up to 20 in non-pandemic times
At least 3 years of CRA experience and 1 years of study management experience
Experience with in vitro diagnostic clinical trials Experience working with infectious diseases and/or oncology clinical trials
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
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