Johnson & Johnson || Site Manager || 2023 || Apply Now
Job Description:
A Site Manager I (SM I) serves as the primary point of contact between the sponsor and the trial site.
A Site Manager I is assigned to 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 policies from study initiation through site closure.
Responsibilities include assisting with site selection, pre-study assessment, subject recruitment and retention planning, study initiation, on-site and remote monitoring, and study closure.
The Site Manager I works with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and Clinical Trial Manager (CTM) to provide overall site management while performing trial-related activities for assigned protocols.
May contribute to process improvement and training.
Responsibilities:
- Acts as primary local corporate contact for assigned sites for specific studies.
- May participate in feasibility and/or pre-study assessment visits
- Participates in investigator meetings as needed.
- Contributes to site level recruitment strategy and contingency planning and implementation in collaboration with other functional areas.
- Ensures study materials at the site (e.g., non-investigational drugs, lab kits, etc.) are adequate for study conduct.
- Ensures that clinical medications are properly used, handled, and stored and that returns are accurately inventoried and documented.
Moreover—-
- Arranges for proper destruction of clinical supplies.
- Ensures on-site staff completes data entry and resolves inquiries within expected timelines.
- Ensures accuracy, validity and completeness of data collected at study sites.
- Lastly, Ensures that data and key documents in systems used for clinical trial management are complete, accurate and timely.
Qualifications:
- At least a BA or BS degree in biological sciences, nursing, or a related scientific field (or equivalent experience) is required.
- At least 1 year of clinical trial monitoring experience is preferred, but other relevant experience and skills may be considered by the hiring manager in assessing the applicant’s suitability.
- Depending on the position, experience in a specific therapeutic area may also be required.
- Strong knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and related protocol specific procedures including monitoring policies.
- Strong IT skills using appropriate software and company systems. Willingness to travel with occasional overnight stays away from home.
- Proficiency in local language and written and spoken English. Good written and verbal communication skills.
About Johnson & Johnson:
- Johnson & Johnson is the largest and broadest-based healthcare company in the world.
- We produce life-changing breakthroughs every day, and have been doing so for 130 years.
- The combination of new technologies and your expertise allows us to accomplish amazing things.
- Teams from J&J’s consumer business are developing digital tools that help people monitor the health of their skin.
- In medical technology, artificial joints are 3D printed to be customized for each patient,
- while researchers in pharmaceuticals are using AI to discover life-saving drugs.
- Imagine what the rest of our team of 134,000 people is doing in 260 companies in more than 60 countries around the world.
- We’re redefining what it means to be a great company in today’s world.
- Caring for the world, one person at a time, inspires and unites the people at Johnson & Johnson.
- We embrace innovation and bring ideas, products and services to life to advance the health and well-being of people around the world.
Moreover—
- We believe in collaboration, and as well as that has led to breakthrough after breakthrough, from medical miracles
- Moreover, that have changed lives to simple consumer products that make every day a little better.
- Our more than 125,000 employees in 60 countries are united in a common mission: to help people everywhere live longer, healthier and happier lives.
- At Johnson & Johnson, we strive to transform the trajectory of human health, and as well as in 2016, many of our achievements contributed to this bold vision.
- Johnson & Johnson Medical India is leading the way in developing and as well as systematically implementing an evidence-based approach to the science behind healthcare decisions.