- Entry level
- No Education
- Salary to negotiate
DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Clinical Research Project Associate to be located in Leeds, UK.
DePuy Synthes Companies is the largest, most creative, comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. With a focus on activating insights to develop creative, comprehensive solutions, we are inspired to advance patient care.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion, we are proud to be an equal opportunity employer.
Operating on behalf of the Medical Device Group, you will contribute to the development of clinical evidence generation and dissemination strategies (EGS/EDS) across assigned New Product Development (NPD) and Life-Cycle Management (LCM) projects.
Contribute to delivery of assigned clinical projects, including development of Global EGS / EDS to support New Product Development and Life Cycle management within the assigned platforms, through strong relationships with all relevant Clinical Research partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.), ensuring alignment.
Contribute towards development of clinical trial protocols, informed consents, investigator brochures, and other study materials;
Plan for study budgets and collaborate with Clinical Operations to own the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures;
Contribute to delivery of assigned clinical projects, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOP);
Develop strong reciprocal relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders;
Draft study reports for assigned studies to include any annual reports, study close out reports as well as clinical sections for IDE, PMA, 510(k), and other regulatory submissions;
Contribute to critical assessment of the literature and drafting Clinical Evaluation Reports (CERs) for new products;
Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections;
Contribute in the interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and use of clinical data/evidence for market access and reimbursement;
Support the collaboration with investigators to deliver and disseminate evidence;
Ensure registration on www.clinicaltrials.gov from study initiation through posting of results;
Develop a keen understanding of the pipeline, product portfolio and business needs.
Keep management informed of key developments and issues that impact clinical strategy and portfolio management.
You may become involved in other tasks to support clinical research activities as needed.
Generally, leads work with supervision, dependent on project complexity. Independent decision-making for simple situations but requires mentorship for complex situations. Senior staff member will review work during development, dependent on level of complexity, and upon completion
Required - Qualifications/Experience/Skills:
A Bachelor’s degree (or University equivalent) in Biological Science or related discipline
Minimum of 4 years related scientific, technical, or clinical research experience
Experience in the Code of Federal Regulations (CFR) or ISO14155 for conducting clinical research trials
Deep understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations
Ability to lead small teams to deliver critical achievements
Ability to collaborate across different
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.