Digital Health Coordinator, Digital Health Center

il y a 2 semaines

Antwerpen, Belgique Johnson & Johnson Temps plein

The Digital Health Coordinator works in the Central Services group of the Digital Health Center of Excellence (DHCoE), and supports operational aspects of various capabilities, primarily in the set-up phase of clinical trials. The incumbent will work closely with Digital Health Managers/Specialists and other Study Team members and ensure copyright license and/or translations are available for services (which may include eCOA, pCOA, paper Diaries). For paper capabilities, the incumbent will be the primary DHCoE point of contact for the crossfunctional study team. The incumbent is expected to maintain an awareness of industry benchmarks and evaluate innovative approaches to ensure Digital Health CoE Central Services processes are at the ‘best practice’ level of performance.

Please note that the job is approved to be performed remotely from either the UK, Belgium or the US.

**Principal Responsibilities**:

- Conduct research and information gathering regarding copyright licensing requirements for COA instruments
- Establish language availability and obtain all required translations for instruments completed by trial participants (such as questionnaires and diaries)
- Complete Request for Proposal documentation, support supplier set-up activities and through lifecycle of the trial
- Manage requests for Purchase Orders, per company financial guidelines
- Support the cross functional study team through changes of scope for Digital Health, providing technical expertise on the change of scope, oversight of new licensing and translations requirements
- Support resolution of issues escalated by study teams under the supervision of the Digital Health Central Services Study Lead
- Work with external business partners in support of R&D Operations’ deliverables
- Provide testing support to Digital Health Managers/Specialists during UATs for digital capabilities
- Manage Best Practices documents for Copyright, Translations and Printing, assist with the development of other standardization documents and procedures
- Assist with inspection readiness activities as needed
- Assist team with vTMF activities across Digital Health CoE
- Assist in conducting continuous improvement ‘Lessons Learned’ sessions following the completion of Digital Health start-up activities, and as necessary, throughout other phases of the clinical development process
- Effectively support the study team in close-out/deactivation of the Digital Health system and archive activities
- Continually assess new emerging processes to optimize operational efficiencies
- Ensure that principles of Credo and Business Conduct Policy, Purchasing Code of Conduct, Healthcare Compliance and Ethical Code of Conduct of Pharmaceutical Medicine are used in supplier relationships

**Principal Relationships**:
The primary working relationships for this position would be
- Internal - DHCoE colleagues, PDO, MAO, GCO, TA, JRP (Procurement), Legal, GCSO (Market Access), HCCo
- External - Vendors, Copyright Holders

**Qualifications**
- Bachelor’s degree (University degree) or equivalent education / relevant experience
- required
- Preferred minimum of 3 years working in a pharmaceutical company and/or a Clinical
- Research Organization, or other equivalent exposure to clinical research
- Demonstrated knowledge of clinical development processes, global clinical operations,
- and strategic planning is required
- Familiarity with industry best practices for vendor management is preferred
- Good understanding of the therapeutic areas where Janssen is involved is required
- Experience with Digital Health Capability/Technology suppliers is preferred
- Strong project management skills and presentation skills

Other:

- Strong written and verbal communication skills in English
- Ability to track, monitor and communicate relevant issues and risks and suggest
- alternative approaches/recommendations
- Ability to work with little supervision and involving management when needed
- Ability to travel up to 10% of time (Domestic/International) is required
- Microsoft Project skills would be an advantage

GIFTS

**Primary Location**
United Kingdom-England-High Wycombe
- **Other Locations**
Europe/Middle East/Africa-Belgium-Antwerp, North America-United States-Pennsylvania-Chesterbrook
**Organization**
Janssen Cilag Ltd. (7360)
**Job Function**
R&D
**Requisition ID**
2206037170W

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