Johnson & Johnson Careers
Clinical Manager, JMP Knees
Clinical Research non-MD
Requisition ID: 2141190418
DePuy Synthes is recruiting for a Clinical Manager JMP Knees, located in Warsaw, IN.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.\ . Responsibilities include:
Plans, manages and monitors daily activities of clinical studies. Ensures that all activities are in compliance with department safety practices, policies and procedures. Implements clinical study parameters, deliverables, policy compliance and resource needs. Applies scientific discipline to minimize risk and increase performance. Participates on cross functional teams for evaluation of new product ideas, implementation of business strategies and so on. Manages analysis and documentation of company clinical work to determine marketability of products. Monitors and reports findings to senior management. Reviews and submits reports, registrations and submissions. Engages with regulatory agencies to support product registrations and gain alignment on clinical strategies where pre-market data collection is required. Assesses internal/external clinical research proposals involving company products relevant to company's objective. Manages project budgets and projections and assists in management of budget across project portfolio. Hires, trains and evaluates staff. Ensures that the staff has the necessary guidance and tools for performance of various projects. Provides technical expertise to formulate clinical development plan. Additional responsibilities:
- Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to develop post market evidence generation strategies that consider global evidence needs.
- Maintain deep understanding of evolving post-market evidence requirements (i.e. FDA and EU Medical Device Regulation).
- Develop and draft Post-market Clinical Follow-up (PMCF) plans, clinical study protocols, registry plans, informed consents, investigator brochures, and other study materials with minimal direction.
- Foster relationships with surgeons, hospitals and research teams to gain input into study design, evaluate study feasibility, and identify sites for study execution or data collection.
- Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and identify issues and communicated to leaders.
- Partner with the Contracts and Payments team to ensure timely execution of all study agreements and corresponding payments for achieved milestones and deliverables.
- Draft Post-Market Clinical Follow-up (PMCF) Reports and study reports with minimal direction for assigned studies to include any annual reports, study close out reports as well as clinical sections for regulatory submissions.
- Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy and communicate evidence.
- Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and Clinical Study Reports (CSR),
- Meet study registration requirements (i.e. clinicaltrials.gov).
- Develop a keen understanding of the orthopedic device product portfolio and business needs for clinical evidence to meet regulatory requirements.
- Keep management informed of key developments and issues that impact clinical strategy and portfolio management.
- Build collaborative relationships with key internal and external partners and stakeholders.
A Bachelor’s degree in Biological Science, Engineering, or related discipline, with a minimum of 4 years related scientific, technical, or clinical research experience is required
- Previous experience in the Medical Device industry is required
- Understanding of Good Clinical Practices is required.
- Demonstrable track record of success managing multiple projects simultaneously with minimal supervision is required.
- Ability to communicate effectively and work with teams is required.
- Advanced technical writing skills is required.
- Understanding and application of US and EU regulations and standards applied to medical device clinical research is preferred.
- Previous experience developing strategies to generate clinical evidence is strongly preferred.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability
Depuy Orthopaedics. Inc. (6029)
Clinical Research non-MD