Senior Local Trial Manager - Janssen, Johnson & Johnson

«out Johnson & Johnson - Janssen For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in the Nordics are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! Johnson & Johnson is a company committed to doing good for the world. We blend Heart, Science and Ingenuity to profoundly change the trajectory of health for humanity. Janssen, one of the Pharmaceutical Companies of J&J, with more than 35,000 employees working hard to treat, cure, stop and prevent some of the most devastating and complex diseases of our time – from autoimmune diseases, hematology, oncology, HIV, mental disorders, heart disease and diabetes. We believe that challenging something is the best way to change it. So, every day, in more than 150 countries, we bring together ground-breaking science and the most creative minds in the industry to think differently about how diseases are treated and prevented. We seek 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. Introduction and Overview Janssen is now looking for one Local Trial Manager (LTM) to the Global Clinical Operation, GCO, department. The position will be office based in Birkerød, Denmark. The Local Trial Manager is responsible for local management of a clinical trial in a country or countries. The LTM is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocols from start-up through to database lock and closeout activities as described in GCO procedural documents. The LTM 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 LTM actively leads or contributes to process improvement; training and mentoring of other LTMs and Site Managers (SM). LTM can work across Phase 1 – 3 studies in multiple therapeutic areas as needed to drive business needs. The LTM may have some site management responsibilities. What you will need to succeed Work in a high collaborative manner. Strong leadership skills and proven ability to lead initiative/small teams. Work in a fast-changing environment. Work on multiple trials in parallel in different disease areas. Build positive relationships internally and externally. Open mind set-and contribute to improve processes in an efficient way. Listen and build an atmosphere of trust and mutual respect. Strongly performance oriented with a passion of delivering high quality within agreed timelines. Qualifications Qualifications - External A Bachelor’s degree in e.g. Life Sciences, Nursing or related scientific field, or equivalent (required). A proven understanding of the drug development process including ICH-GCP, local law and regulation (required). Proficient in Danish and English language (required). Willingness to travel with occasional overnight stay away from home (required). A minimum of 4 years’ experience of project leading in clinical trial (preferred). Experience from Early Development studies (preferred). Application If you are interested in this position, please apply with an updated CV in English. The selection process will start during the posting period, please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Primary Location Denmark-Hovedstaden-Birkerod- Organization Janssen Cilag A/S (7070) Job Function R&D Requisition ID 2206063929W