Senior Site Manager

3 weeks ago

Mumbai, Maharashtra, 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 https www jnj com Job Function R D Operations Job Sub Function Clinical Trial Support Job Category Professional All Job Posting Locations Mumbai India PENJERLA Telangana India A Senior Site Manager is a mid-level site management role with typically 3-5 years of clinical monitoring experience This role serves as the primary contact point between the Sponsor and the Investigational Site A Senior Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol company Standard Operating Procedures SOP Good Clinical Practice GCP and applicable regulations and guidelines from study start-up through to site closure Responsibilities may include assisting with site selection site qualification assessment subject recruitment and retention planning site initiation on-site and remote monitoring and close-out activities The Senior Site Manager will partner with the Local Trial Manager LTM Clinical Trial Assistant CTA and TDL Trial Delivery Leader to ensure overall site management while performing trial related activities for assigned protocols A Senior Site Manager may contribute to process improvement training and mentoring of other Site Managers A Senior Site Manager is generally expected to be able to operate independently with little or limited supervision Assists throughout the start-up execution and completion of clinical research studies ensuring the safety and confidentiality of all study subjects Documents site visits investigational product assessments and other relevant observations and identifies opportunities to improve outcomes Acts as a point of contact for the clinical trial team and escalates issues to appropriate trial leaders Gathers data on the clinical trial environment and measures against key performance indicators Observes and trains patients on trial purpose and outcomes in accordance within all regulatory requirements under general supervision Maintains records and documentation of safety related events Coaches more junior colleagues in techniques processes and responsibilities Understands and applies Johnson Johnson s Credo and Leadership Imperatives in day-to-day interactions with team

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