Clinical Project/Study Manager (Clinical Research Scientist III) (Warsaw, IN)-2290130226
DePuy Synthes, a member of the Johnson & Johnson Family of Companies is recruiting for a Clinical Project/Study Manager (Clinical Research Scientist). This position is located in Warsaw, IN.
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 may require minimal supervision associated with product development.
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.
Assists with front end activities related to clinical feasibility, standards and evaluation methods to formulate evidence generation strategy.
May assist with preparations for Clinical Research Committee and Protocol Review Committee meetings.
Conducts literature reviews, may draft clinical trial protocols and study reports with supervision.
May support publication strategy execution.
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.
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.
Supports the implementation of new clinical systems/processes.
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.
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.
The following experience is required, 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.
Relevant industry certifications preferred (i.e. CCRA, RAC, CDE) 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
Demonstrated competencies in the following areas is preferred:
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-Indiana-Warsaw
Organization: Depuy Orthopaedics. Inc. (6029)
Yes - Within Country
Travel:Yes, 25 % of the Time
Job Function: Clinical Research non-MD
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