As the world's largest and most broadly based healthcare company, we impact more than a billion lives through the innovation happening at 260+ companies located in 60 countries around the world. Teams from Johnson & Johnson’s consumer business are improving quality of life by creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals are using AI to discover lifesaving drugs. We redefine what it means to be a big company in today’s world.
Who is Janssen? Simply put, we’re people; more than 35,000 working hard to treat, cure, stop and prevent some of the most devastating and complex diseases of our time — from heart disease, diabetes, and psoriasis to Alzheimer’s, HIV, and cancer. We believe that challenging something is the best way to change it. So, every day, in more than 150 countries, we bring together cutting-edge science and the most creative minds in the industry to think differently about how diseases are treated and prevented. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health. We are Janssen. We collaborate with the world for the health of everyone in it.
To support our team in Germany, we are currently hiring a Site Manager (m/f/d)
A Site Manager (SM) serves as the primary contact point between the Sponsor and the Investigational Site. A SM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company SOPs, GCP, and applicable regulations and guidelines from study start-up to site closure. Responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The SM will partner with the Local Trial Manager (LTM), Clinical Trial Assistant and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement and training.
- Acts as primary local company contact for assigned sites for specific trials
- May participate in site feasibility and/or pre-trial site assessment visits
- Attends/participates in investigator meetings as needed
- Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring, site management and site/study close-out.
- Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
- Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
- Ensures site staff complete data entry and resolve queries within expected timelines.
- Ensures accuracy, validity and completeness of data collected at trial sites.
- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field is required.
- A minimum of 1 year of clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.
- Specific therapeutic area experience may be required depending on the position.
- Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
- Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
- German: Native
- English: Fluent
Type: Field job with flexible area of responsibility/territory
The well-being and development of our employees are central aspects of our company creed. Individuals who would like to fully realize their potential as part of our international, innovation-driven corporate family and who aspire to have challenging work, will find that our company provides just the right conditions. We consider intensive initial training, further education that is tailored to our employees' work and excellent opportunities for development - both nationally and internationally - to be just as essential as a good work-life balance, attractive compensation and above-average employee benefits. One aspect that distinguishes our company is the large number of measures we have to support our trainees and promote career development in ways that are also compatible with family life.
Germany-North Rhine Westphalia--
Janssen-Cilag Germany (8000)