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Clinical Research Study Manager (Clinical Research Scientist III-Raynham, MA)-3275130307
DePuy Synthes, a member of the Johnson & Johnson Family of Companies is recruiting for a Clinical Research Study Manager (Clinical Research Scientist III). This position is located in Raynham, MA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will 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. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
This experienced professional will be responsible for Clinical Research Portfolio management within designated DePuy Synthes Operating Company, as well as fostering strong, productive relationships with colleagues within the Organization. Responsible for the management of non-regulated studies and low complexity regulated studies, and may lead project teams. May assist other leaders with the management of more complex, high-risk studies.
The qualified individual will be responsible for, but not limited to the following:
Manages non-regulated studies (Investigator Initiated, Registries, or company sponsored Postmarket studies) and low complexity regulated studies (Post-Approval, 522).
Assists with high complexity studies and may manage components.
Completes required templates and documents, and maintains records related to assigned projects.
Participates in Project Core Team (PCT) activities and provides input and completes clinical tasks and with minimal supervision associated with product development.
Ensures the completion of required templates and documents, and maintenance of records.
Responsible for front end activities related to clinical feasibility including literature reviews with minimal direction.
Participates in formulating evidence generation strategies with input from Medical Affairs
Manages and monitors the progress of assigned Investigator Initiated Studies including interacting with the primary investigator and site staff, verification of milestones, budget tracking, and generation of evidence according to agreements.
May determine fair market value (FMV) and plan for study budgets under direction of senior clinical leaders.
Verifies milestones and tracks payments for assigned Operating Company-managed projects.
Develops an understanding of other functional areas within the Office of Science and Technology and the Operating Company.
Works closely 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.
Collaborates with Franchise Clinical Operations, to ensure site staff including primary investigators and coordinators are appropriately trained and conducting the study according to the protocol and agreements.
May assist with preparations for Clinical Research Committee and Protocol Review Committee meetings.
Drafts clinical trial protocols with supervision.
Conducts literature reviews and drafts study reports for assigned studies to include any unanticipated adverse event reporting, annual reports, study close out reports as well as clinical sections for IDE, PMA, 510(k) and other regulatory submissions with supervision
May support publication strategy execution including collaboration with investigators and internal stakeholders.
Develops materials to be used by Clinical Operations for study execution (investigator brochures, training materials, etc.).
May assist with the review clinical information required for periodic safety and post-market surveillance reviews in collaboration with Medical Affairs.
Supports the implementation of new clinical systems/processes.
Develops high standards of critical thinking, analysis, collaboration and communication for the advancement of clinical programs.
Develops a strong understanding of the Operating Company product portfolio and pipeline.
Keep management informed of key developments and issues that impact clinical strategy and portfolio management.
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 Synthes' business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
May be involved in other tasks to support Clinical Research activities or 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 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.
A minimum of a Bachelor's degree or equivalent is required. Preferably in Life Sciences, Biomedical Engineering or related field. An advanced Medical Science or Medical degree is preferred.
Certification from a recognized professional organization (i.e. ACRP, SoCRA) is preferred. Relevant industry certifications preferred (i.e. CCRA, RAC, CDE) is preferred.
The following minimum durations of relevant experience is preferred: BS degree with 4 or more years of experience; Master's degree with 2 or more years of experience; OR advanced degree, PhD/MD/PharmD with 1 or more years of experience.
Previous clinical research or related technical experience required; orthopedic or neurologic device experience is preferred.
An understanding and application of regulations and standards applied to medical device clinical research is preferred.
Experience in clinical research in a project leadership position in the medical device or related industry is required.
Demonstrated competencies in the following areas are required:
Leadership in a professional and ethical manner
Presentation skills and influencing of others
Written and oral communication skills
Critical thinking and application of scientific research principles
Working knowledge of Good Clinical Practices
Project management skills with ability to handle multiple projects
Knowledge of orthopedic and/or neurological device clinical research is preferred
Leading individuals or small teams is preferred
Ability to travel domestically and internationally up to 20%.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Massachusetts-Raynham
Organization: Depuy Orthopaedics. Inc. (6029)
Job: Clinical Research non-MD
Deadline: Thursday, 1 August 2013