Clinical Trials Manager
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POST DATE 8/27/2016
END DATE 12/19/2016
JOB DESCRIPTIONPosition Description
Clinical Trials Manager
Company : Sanofi
Under supervision of the Manager, Clinical Affairs, the Clinical Trial Manager plans and executes clinical studies of varying complexity in support of FDA 510k, PMA and BLA submissions, and international registrations. Works within US and international regulatory guidelines and GCP. Leads cross functional clinical team. Prepares clinical study protocols and related documents. Develops CRO and site management/monitoring plans and participates in clinical sample acquisition and clinical study implementation.
Assists in identification and selection of Principal Investigators and clinical study sites. Assists in preparation of clinical study agreements and clinical site budgets. Monitors study costs and coordinates payments. Assists in preparation of training documents and study materials. Trains/assists in training of Principal Investigators, study sites, CROs and vendors.
Manages external partners and oversees outsourced work. Participates in clinical study execution and study materials management. Reviews and monitors diagnostic assay data as received and conducts periodic onsite monitoring of clinical sites to ensure protocol adherence, data integrity and regulatory compliance. Prepares trial master file structure and assists in TMF maintenance. Prepares clinical summaries and reports.
BachelorDegreerequired, preferably in biological or medical sciences. Master's Degree or higher is desirable.
Minimum of 5years direct clinical research experience, of which a minimum of 2years clinical research supervisory or management capacity with budgetary responsibility.
Knowledge of applicable standards and regulations for clinical trial and laboratory conduct
Proven oral and written communication skills
Proven planning skills; ability to create and track detailed project plans
Proven interpersonal, leadership and organizational skills & Effective time management
Ability to work independently and within a cross-functional team environment to analyze and solve problems, and to make sound decisions
Basic biostatistical knowledge
Must be willing to periodically work with potentially biohazardous materials in an approved safe manner and to work in biohazardous environments
Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates
2years IVD Monitoring experience
Experience in Cardiac clinical studies
Strong technical lab expertise with demonstrated ability in assay analysis and data interpretation
Travel up to 30% on an annual basis.