Job Detail

Staff Clinical Research Project Manager (Staff Clinical Research Scientist)

Inseriert am: 22.01.2019



Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. 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. Building on the legacy and strengths of two great companies, we created one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.

 

For our EMEA headquarters in Zuchwil, Solothurn we are looking for an experienced


Staff Clinical Research Scientist


your responsibilities:



  • Support non-regulated (Investigator Initiated, Registries, or company sponsored post-market studies) and regulated studies (IDE, HDE, Post-Approval, 522). 

  • Assist with high complexity studies and may support components

  • Participate in product development Project Core Team (PCT) activities and provide input and complete clinical tasks

  • Support front end activities related to clinical feasibility including literature reviews

  • Support Clinical Evaluation Reports for new products

  • Support development of evidence generation and publication strategies with input from cross functional teams

  • Support the progress of assigned Investigator Initiated Studies, including interacting with the primary Investigator and site staff, verify milestones, track budgets, and generate evidence according to agreements

  • Develop collaborative relationships with other functional areas within the Office of Science and Technology and the Operating Company

  • Develop strong collaborative relationships with Study Core Team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders

  • Support maintainance of registration on www.clinicaltrials.gov from study initiation through posting of results

  • Support collaboration with investigators and internal stakeholders to support publication strategy execution

  • May support the review of clinical information required for periodic safety and post-market surveillance reviews in collaboration with Medical Affairs

  • Apply high standards of critical thinking, analysis, collaboration, and communication for the advancement of clinical programs

  • Develop a strong understanding of the Operating Company product portfolio and pipeline, and business needs

  • 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

  • May be involved in other tasks to support clinical research activities or Operating Company as needed

  • Consistently strive to improve the performance, reputation, and image of the clinical organization

  • Ensure efficient use of resources to provide high quality deliverables

  • 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


Qualifications



  • BS/BA or equivalent, preferably in Life Sciences, Biomedical Engineering, or related field required.

  • Minimum years of relevant experience: BSc with 7+ years; Master’s with 5+ years; PhD/MD/PharmD with 3+ years

  • Previous clinical research or related technical experience required

  • Understanding of Good Clinical Practices

  • Application of scientific research principles

  • Understanding and application of regulations and standards applied to medical device clinical research

  • Presentation skills and influencing of others 

  • Written and oral communication skills 

  • Advanced technical writing skills 

  • Advanced project management skills with ability to handle multiple projects

  • English business fluent

  • Ability to travel domestically and internationally up to 20%


If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.) by clicking here.


 

Please click on
 DePuy 
Synthes and 
Johnson & Johnson if you want to learn more about our business and check our new career channel on YouTube  
www.youtube.com/user/CareersAtJNJ
 to understand our working culture!


Primary Location

Switzerland-Solothurn-Zuchwil-


Organization

Synthes GmbH (7111)


Job Function

Clinical Research non-MD


Requisition ID

1805690725W

Details