- Actively contribute to protocol planning and development and case report forms
- Prepare agendas and meeting minutes for study meetings and lessons learned meetings
- Review study plans and provide feedback to GD MADU
- Develop study trackers (i.e., enrollment tracker, Steering Committee tracker)
- Assist with user acceptable testing for clinical trial systems
- Prepare presentations and reports for leadership
- Issue identification and resolution and proactive risk mitigation
- Lead the preparation and scheduling of Steering Committees, Data Safety Monitoring Boards and Investigator Meetings under oversight of the SRPs
- Key liaison (primary point of contact) with our GD MADU partners and other scientific and business-related disciplines (e.g., R&D, Clinical Supplies, QA, etc.)
- In concert with medical/clinical personnel, the Clinical Project Scientist assists with execution of clinical studies; interpretation of results; preparation of oral and written internal/external presentations; development, management, and tracking of trial budgets; and budget and contract development with third party vendors
- Assist with tracking and managing adverse event data collection across trials; and where appropriate, incorporation into obligatory regulatory documents
- Collaborates with TA lead, Medical Directors and counterparts in GD MADU to develop strategic IIS guidance documents and support IIS projects across the portfolio
- Serve as the primary liaison between J&J Innovative Medicine and Clinical Investigators
- Manages monthly/periodic meetings to monitor and update organizational logistics of IIS proposal intake, review, and tracking
- Actively review and provide feedback per SOPs for protocols and Informed Consents
Manager, Clinical Project Scientist - Horsham, United States - Johnson & Johnson
Description
Johnson & Johnson Innovative Medicine is recruiting for a Manager, Clinical Project Scientist to be located in Horsham, PA.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
This individual contributor will be a part of the US Medical Affairs Immunology Clinical Operations & Program Management Team and support one to two therapeutic areas.
The Manager, Clinical Project Scientist, is responsible for successful implementation of the Investigator Initiated Study (IIS) program as well as company sponsored trials, collaborative studies and post marketing commitment studies, including both interventional, non-interventional and registry studies.
In this role, the individual will work closely with the Therapeutic Area Lead, the Medical Directors (Study Responsible Physicians) responsible for individual assets, the Medical Science Liaison (MSL) team, and Global Development Medical Affairs Delivery Unit (GD MADU) to review submitted IIS proposals and execute, track, manage and oversee approved IIS protocols.
He/she will work with the Medical Directors, MSL team, and GD MADU to ensure that IIS trials are executed in a timely and compliant fashion to deliver data to support evidence generation needs in the US.
This individual will also work closely with the Study Responsible Physicians and Research Scientists for US Medical Affairs sponsored studies, to ensure that these company sponsored studies and collaborative studies are conducted and executed in a timely manner.
A key responsibility will be review and coordination of all project-related documentation, leading the Steering Committee process with SRPs, completing user acceptance testing of systems and leading Lessons Learned Meetings.
As a leader on the Study Team, this individual will identify issues and potential operational hurdles within a project and propose options for resolution in coordination with the Study Responsibility Physician, Study Responsible Scientist and Global Trial Leader(s).
This individual is the main point of contact for GD MADU for studies.Interfaces with multiple scientific partners related to planning and strategy for therapeutic area trials and publication strategy. Interfaces with insourced and outsourced trial execution resources within the GD MADU organization. Considered by peers as a clinical trials expert, technically proficient, intelligent, and results oriented. Able to think creatively, critically, and proactively, with strong problem-solving skills. Collaborative and flexible in personal interactions at all levels of the company. This individual will interface regularly with both internal and external stakeholders and vendors.
Major Responsibilities:
Clinical Project Scientist for assigned company sponsored, collaborative, post marketing and registry Trials including but not limited to: