Clinical Research Portfolio Leader - DePuy Warsaw Indiana Job
Johnson & Johnson
Job Code - 59152
Position - See job description
Job First Active on: Friday, April 06, 2012
Clinical Research Portfolio Leader - DePuy Warsaw, Indiana
DePuy Orthopaedics, Inc, a member of Johnson & Johnson's Family of Companies, is recruiting for a Clinical Research Portfolio Leader , located in Warsaw, Indiana.
The DePuy Family of Companies has a rich heritage of pioneering a broad range of products and solutions across the continuum of orthopaedic and neurological care. These companies are unified under one vision - Never Stop Moving® - to express their commitment to bring meaningful innovation, shared knowledge and quality care to patients throughout the world. DePuy Orthopaedics, Inc., DePuy Spine, Inc., DePuy Mitek, Inc., and Codman & Shurtleff, Inc. develop and market products for reconstructing damaged or diseased joints; repairing and reconstructing traumatic skeletal injuries; facilitating the treatment of spinal disorders and deformity; repairing soft tissue in the shoulder, knee and other joints through minimally invasive means; and surgically treating neurological and central nervous system disorders. DePuy has three main locations: Warsaw, Indiana and Raynham, Massachusetts in the U.S. and Leeds in the UK.
This individual will be responsible for Clinical Portfolio management within DePuy Orthopaedics, as well as fostering strong, productive relationships with colleagues within the Organization and within Franchise Clinical Operations.
Responsible for strategic oversight and management of a few to several medium to large Clinical Projects in different geographies, some of which could be regulated studies, including design and reporting of associated clinical studies.
Understand business value and balances overall business objectives and functional needs.
Develop and/or support the implementation of new clinical systems/processes.
Interface and collaborate with clinical investigators as appropriate.
Lead and/or contribute to the development of clinical research strategies as part of Project Core Teams (PCTs), and align internally within OpCo to ensure strategy, milestones and funding are agreed
Develop, in conjunction with PCT, and execute publication strategy for assigned clinical projects.
Oversee assigned projects budgets to ensure adherence to business plans.
Manage Resources within projects to provide quality deliverables while maintaining optimal efficiency.
Proactively addresses clinical research questions and/or problems that impact future clinical trial design.
Conduct and/or contribute to periodic literature reviews of assigned products as appropriate.
Develop and write clinical trial protocols (and amendments) to high standards and ensure their review and approval through appropriate governance committee(s) Develop and write Investigator Brochures (and updates) to high standards and ensure their review and approval through appropriate governance committee(s)
Train and/or support Clinical Trial Teams in Franchise Clinical Operations on products, clinical strategy, trial design and monitoring needs as appropriate
Partner with Franchise Clinical Operations to select Clinical Research vendors and Investigators
Partner with Franchise Clinical Operations to develop Informed Consents, Case Report Forms and Investigator meeting/Site Initiation Meeting content
Monitor progress and conduct of clinical program(s) by Franchise Clinical Operations, partnering as appropriate with Clinical Project Management and other functions to address issues with assigned studies, including investigator non-compliance.
Assist in the coordination of regulatory submissions, including providing clinical study protocols and reports.
Partners with Clinical Quality, Medical/Clinical team and Regulatory to investigate and report device related adverse events, as appropriate. Act as the Clinical research representative on corporate task forces, as appropriate.
Insures appropriate, approved information is posted on ClinTrials.gov for assigned clinical studies.
Perform all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information.
Know, understand, incorporate and comply with all applicable laws and regulations relating to DePuy's business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
May be involved in other tasks to support Operating Company as needed.
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance.
Provide quality feedback to the Directors and Managers of each Resource area with regard to employee performance within the context of the Clinical studies.
May be asked to provide training to DePuy employees or other individuals and/or group as needed.
REQUIREMENTS - QUALIFICATIONS: Clinical Research Portfolio Leader - DePuy Warsaw, Indiana
A minimum of a Bachelor's degree is required.Certification from a recognized professional organization (i.e. ACRP, SoCRA) and relevant industry certifications (i.e. CCRA, RAC, CDE) preferred.Previous clinical research experience required, from within the Medical Device industry or relevant industry (i.e Pharmaceuticals). Desirable minimum durations of relevant experience with:A Bachelor's degree with 3 or more years of relevant experience; A Master's degree with 2 or more years of relevant experience; A PhD/MD/PharmD with 2 or more years of relevant experience.Project Leadership experience/skills are preferred.Requires understanding and application of regulations and standards applied in clinical areas and medical devices/combination products. Demonstrated competencies in the following areas::Demonstration of Leadership in a professional and ethical manner is required.Demonstrated presentation skills and Influencing of others is required.Demonstrated written and oral communication skills is required.Demonstrated expertise in guidelines for conduct of clinical studies and associated regulations is required.Demonstrated expertise in orthopaedics and orthopaedic clinical research specifically joint replacement research experience is preferred.Health Outcomes experience preferred.Previous experience writing journal articles preferred.Experience in managing regulated and non-regulated studies for different types of products preferred.Demonstrated project management skills required.Demonstrated excellence in Clinical Strategic thinking required.Capable of mentoring and training junior colleagues preferred.
Johnson & Johnson
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