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 https://www.jnj.com
Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom
Job Description:
About innovative medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United States - Requisition Number: R-031590
We are searching for the best talent for a Senior Specialist, Digital Health Operations to be located in Titusville, NJ; Spring House, PA; La Jolla, CA or High Wycombe, United Kingdom.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
Purpose: The Senior Specialist, Digital Health Operations is primarily responsible for leading Digital Health and Operational aspects of various technologies. This individual will be required to demonstrate technical expertise in system development, user acceptance testing and provide subject matter expertise to cross-functional study teams. The Senior Specialist will lead all Digital Health-related activities and will be the point of contact for the cross-functional study team. They will be expected to maintain an awareness of industry benchmarks and evaluate innovative new technologies to ensure Digital Health processes are at the ‘leading practice’ level of performance.
You will be responsible for:
- Serving as a subject matter expert for Digital Health, providing advice/recommendation to study teams regarding the supplier(s) and device/technology alternatives.
- Completing Requests for Proposal documentation, and recommending appropriate suppliers to support study needs.
- Providing leadership and expertise for the completion of supplier specification development and set-up activities through lifecycle of the trial.
- Leading cross-functional study teams through changes of scope for Digital Health, providing technical expertise on the change of scope, assessment of risk, oversight of system requirements updates and user acceptance testing.
- Assisting in the resolution of issues escalated by study teams for processes owned, as well as cross-team specific issues under the supervision of the Digital Health Delivery Unit Lead.
- Assisting with inspection readiness activities as needed.
- Monitoring key performance indicators (KPIs) for services provided by suppliers.
- Conducting Lessons Learned sessions following the completion of study start-up activities, and as necessary, throughout other phases of the clinical development process.
- Effectively supporting the study team in close-out/deactivation of the Digital Health system and archive activities.
- Continually reviewing new emerging technologies focusing on efficiencies to be gained.
- Ensuring that principles of the Credo and Business Conduct Policy, Purchasing Code of Conduct, Healthcare Compliance and Ethical Code of Conduct of Pharmaceutical Medicine are used in supplier relationships.
Qualifications / requirements:
Education:
- A minimum of a Bachelor degree is required. An advanced degree is preferred.
Experience and Skills:
Required:
- 4+ years operational experience in clinical trials with a pharmaceutical company and/or a Clinical Research Organization is required.
- Demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning is required.
- Familiarity with industry best methods for vendor management is required.
- Good understanding of the therapeutic areas where Johnson & Johnson is involved is required.
- Strong project management skills and presentation skills with the ability to lead a team independently is required.
- Strong verbal and written communication skills are required.
Preferred:
- Experience with Digital Health Technology suppliers is preferred.
- Microsoft Project skills would be an advantage.
Other:
- Ability to travel up to 10% of the time, both Domestic and International is required.
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