- Executes clinical research strategies and contributes to the development and execution of clinical research programs
- Directs end to end delivery of clinical studies
- Defines clinical study parameters, supports deliverables, policy compliance and resource needs
- Serves as a clinical point of contact for cross functional teams and program level workstreams
- Reviews, evaluates, interprets results of clinical trial data preparation for submission and assists with interactions with regulatory health authorities
- Leads and performs medical monitoring/reporting, evaluates ongoing clinical trial data
- Manages and provides oversight on trial results
- Assists with development of clinical research protocols, study case report forms, informed consent forms
- Organizes documentation needed for data collection, analysis
- Reviews and maintains protocol specifications in alignment with standard operating procedures
- Guides and mentors less experienced team members in adherence to clinical research guidelines and safety procedures
- Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies
- Communicates detailed outcomes and results of research findings to relevant partners
- Anticipates areas of opportunity to ensure delivery of a quality database and contributes to data quality process improvements
- Presents research status at internal/external meetings, including investigator meetings and company sponsored events
- May lead one or more program or therapeutic area initiatives
- Works with high level of autonomy, providing decision accountability for project, owns escalations, and communicates effectively at all levels, including senior stakeholders
- Experience developing, presenting, and leading clinical data discussions
- Mentorship of less experienced team members and may have direct reporting/people management accountability
- Members of the Clinical and Cross Functional Trial teams
- Members of Oncology TA
- Cross Functional Senior Management
- May act as a liaison, in partnership with Global Operations and Study Responsible Physician, between company and Investigators, Site Managers, Site staff, global clinical research staff, vendor project managers, and CROs
- Develops credible relationships with senior leaders, opinion leaders, medical directors, and key regulatory officials
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Director, Clinical Project Scientist - Warsaw, United States - Johnson & Johnson
Description
At Johnson & Johnson, we believe health is everything.Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at .We are currently seeking a Director, Clinical Project Scientist located in Warsaw, Poland.
Remote based options within Poland may be considered on a case by case basis and if approved by the company.
A pre-identified candidate has been identified for the position, however all applications will be considered.
The Director, Clinical Project Scientist (CPS) develops and leads goals/objectives and end to end delivery of clinical trials within the Oncology Therapeutic Area, including but not limited to designing, planning, developing, monitoring, and reporting of clinical research data.
Essential Functions:
Contacts within the Company:
Contacts outside the Company: