Clinical Research Specialist

Êring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo. DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world. We are looking for a highly committed: Clinical Research Specialist based in Zuchwil (Fixed Term) Overview This professional will be responsible for assisting Clinical Research Leaders in the management of the clinical portfolio for the designated DePuy Synthes Operating Company, including managing components of regulated activities with supervision, and leading low complexity, nonregulated studies (Investigator Initiated, Registries, or company sponsored post-market studies).He/she may assist with the management of high-risk or complex studies. Further responsibilities and duties are Primary performs the role of Clinical Study Lead, and may perform other roles including Clinical Operations Lead. Manage low complexity, non-regulated studies (Investigator Initiated, Registries, or company sponsored Postmarket studies). Assist with high complexity or regulated studies (IDE, HDE, Post-Approval, 522), and may manage components. Complete required templates and documents, and maintain records related to assigned projects. Develops an understanding of the roles and responsibilities of other functional areas including Franchise Clinical Operations, Biostatistics and Data Management, Medical Affairs, Evidence Based Medicine, Regulatory Affairs, Legal, Health Care Compliance, Research and Development, and Marketing. Complete clinical tasks related to product development activities; may participate in Project Core Team (PCT). Assist in front end activities related to clinical feasibility, including literature reviews. Assist with the development of materials to be used by Clinical Operations for study execution (Investigator Brochures, training materials, etc.). Manage and monitor the progress of assigned Investigator Initiated Studies, including interacting with the primary Investigator and site staff, verifying milestones, tracking budgets, and generating evidence according to agreements. Verify milestones and track payments for assigned Operating Company-managed projects. Collaborate with Franchise Clinical Operations, Biostatistics and Data Management, and other functions to ensure study progress for assigned projects, and issues are identified and communicated to leaders, as well as, ensure site staff, including primary Investigators and study coordinators, are appropriately trained and conducting the study according to the protocol and study agreements. Responsible for technical writing, which may include drafting of components of protocols, study reports, reports to regulatory bodies, or summaries of clinical literature. Support the implementation of new clinical systems/processes. Keep management informed of key developments and issues that impact clinical strategy and portfolio management. Ensure the completion of required templates and documents, and maintenance of records. Develop high standards of critical thinking, analysis, collaboration, and communication for the advancement of clinical programs. Develop an understanding of the Operating Company product portfolio and pipeline. May assist in determining fair market value (FMV) and planning for study budgets. May assist with preparations for Clinical Research Committee and Protocol Review Committee meetings. May assist with the review clinical information required for periodic safety and post-market surveillance reviews in collaboration with Medical Affairs. May be involved in other tasks to support clinical research activities or Operating Company as needed. Provide leadership and input for project teams including Project Core Teams and/or Clinical Study Core Teams. Know, understand, incorporate, and comply with all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct. Provide quality feedback to the Directors and Managers of each resource assigned to clinical studies regarding employee performance within the context of the clinical studies. May be asked to provide training to DePuy Synthes employees or other individuals and/or group as needed. Qualifications BS/BA or equivalent, preferably in Life Sciences, Biomedical Engineering, or related field Advanced medical science or medical degree is desirable. Desirable minimum durations of relevant experience: BSc with 3 years; Masters with 1 year PhD/MD/PharmD with 0 to 1 year. Previous clinical research or related technical experience required. Experience with medical devices is desirable. Certification from a recognized professional organization (i.e., CCRA, RAC, CDE) is Application of scientific research principles Understanding of Good Clinical Practices Demonstrated competencies in the following areas are required: Leadership in a professional and ethical manner Presentation skills and influencing of others English written and oral communication skills Technical writing o Project management skills Ability to travel domestically and internationally up to 20%. 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 Switzerland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! If you want to be a change agent in a challenging environment and shape the future quality organization, please send us your online application (CV, Motivation Letter, Working References etc.). Primary Location Switzerland-Solothurn-Zuchwil- Organization Synthes GmbH (7111) Job Function R&D Requisition ID 2206018330W