Manager, Clinical Research and Prospective Studies (Remote Position)AmerisourceBergen Corporation
Manager, Clinical Research and Prospective Studies (Remote Position)
Title: Manager, Clinical Research and Prospective Studies (Remote Position)
Location: United States
Job Number: 00001MAT
POSITION SUMMARY: The Manager, Prospective Research is responsible for clinical operational planning activities and leading study execution in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Xcenda Standard Operating Procedures. PRIMARY DUTIES AND RESPONSIBILITIES: The responsibilities of the Manager, Prospective Research may include, but are not limited to the following: Develops protocols, study budgets and timelines Conducts qualification, initiation, interim and close out monitoring visits and prepares visit reports Designs and reviews ICF templates, CRFs, procedure manuals, and other project-specific documents Manages study sites from study start-up through close-out to ensure adherence to protocol and regulations Monitors study data to ensure accuracy and integrity; generates and resolves data queries Creates and maintains the Trial Master File (TMF); ensures that site regulatory documents are acquired, complete, and compliant Coordinates IRB submissions, amendments and annual updates Trains and initiates investigative sites Facilitates the distribution of supplies, forms, equipment, study medications and study devices to sites Ensures investigational product reconciliation, reviews inventory and dispensation records, and verifies subject compliance Tracks and ensures patient enrollment targets are achieved Verifies appropriate reporting and documentation of adverse events and protocol deviations per protocol requirements Ensures adherence to protocol, ICH, GCPs, SOPs Assists in the preparation of proposals in response to RFPs received from clients.
EXPERIENCE AND EDUCATIONAL REQUIREMENTS: • Bachelor’s degree in life-sciences or related field • Minimum of 5 years clinical research experience in the pharmaceutical or medical device industry • Strong working knowledge of GCPs and Federal Regulations • High level of organization and self-motivated to manage multiples sites and projects simultaneously • Previous experience with electronic data capture systems is preferred • Proficiency in MS Word, MS Excel, MS PowerPoint • Excellent written and oral communication skills MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS: • Work independently and proactively • Strong organizational skills • Detail oriented • Strong work ethic • Positive attitude • Functions as a team player • Work efficiently on all tasks within the allotted number of hours by deadline • Excellent verbal and written communication skills • Ability to manage a diverse project load • Produce positive results in a high-pressure environment • Prioritize tasks and complete assignments in a thorough and competent manner • Recognize areas to increase efficiency and contribute solutions
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AmerisourceBergen is one of the world's largest pharmaceutical service companies serving the United States, Canada and selected global markets with a focus on the pharmaceutical supply channel. Servicing both pharmaceutical manufacturers and healthcare providers, the Company's service solutions range from niche premium logistics and pharmaceutical packaging to reimbursement and pharmaceutical consulting services. Our scale, our position in the healthcare industry, and the value we bring to the channel have all helped our business continue to succeed.