Sr. Local Trial Manager

4 days ago

bangalore, India Johnson & Johnson Full time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: R&D OperationsJob Sub Function: Clinical Trial Project ManagementJob Category:ProfessionalAll Job Posting Locations:Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, IndiaJob Description:A Senior, Local Trial Manager is a mid-level trial management role with typically at least 2 years of clinical trial management or 5-8 years of clinical monitoring experience. This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The Senior, Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. The Senior, Local Trial Manager is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Senior, Local Trial Manager actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and Associate, Local Trial Managers.Required Skills: Preferred Skills:Business Behavior, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Give Feedback, Laboratory Operations, Medical Knowledge, Mentorship, Problem Solving, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics

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