Business Title CHS&O EPRO OPERATIONS EXPERT

Job description

CONNECTED HEALTH SOLUTIONS OPERATIONS EXPERT
Locations: Onsite: Malvern / Spring House Pennsylvania, USA or High Wycombe UK
PAYGRADE: 26

At the Janssen Pharmaceutical, A Johnson & Johnson Company, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science.
Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer

ROLE OVERVIEW

You will act as the operations authority within the team, ensuring clinical study technology solutions are study specific, validated and compliant. Using your in-depth knowledge of systems development, user acceptance testing (UAT) and subject matter expertise to lead delivery of e-Informed Consent, eMeds, and Apps for ePRO collection technologies. You will maintain an awareness of industry benchmarks and evaluate creative new technologies to ensure team processes are at the highest level of performance.
From your clinical study or research background you will be able to apply your skills to improve in the development of patient data capture software. Using your project managements and leadership skills to ensure multiple technical projects are completed within agreed timeline's while working with a variety of partners and external vendors. You will have a keen interest in the application of technology in the health and pharmaceutical industries and how applications and other technologies can be used in industry.

JOB RESPONSIBILITIES:

- Assist with inspection readiness activities
- Monitoring key performance indicators for services provided by your suppliers
- You will effectively support the study team in close-out/deactivation of systems
- Provide leadership related to supplier specification development and set-up
- Continually review new emerging technologies focusing on efficiencies to be gained
- Conduct regular review sessions throughout all phases of technology development process.
- Provide advice/recommendation to study teams regarding the supplier(s) and device/technology alternatives
- Provide technical direction to the cross-functional study team through changes of scope providing expertise/scope change, assessment of risk, oversight of system requirements updates and UA testing as necessary
- Assist in the resolution of issues brought up by study teams with minimal supervision by CHS&O line manager
- Ensure that principles of Credo and Business Conduct Policy, Purchasing, Healthcare Compliance and Ethical Codes of Conduct of Pharmaceutical Medicine are used in supplier relationships

Desired profile

Qualifications :

ESSENTIAL SKILLS AND EXPERIENCE

- Project management experience
- 3 years + experience in clinical studies / research
- Bachelor's degree (University degree) or equivalent in Sciences
- Proven ability and desire to teach others and share knowledge
- Expertise working w/Apps, e-Informed Consent technologies preferred
- 3 years or more technologies experience in a pharmaceutical / Clinical Research Organization
- Excellent understanding of CNS, CV/Met, Immunology, Infectious Disease or Oncology therapies
- Use your strong analytical skills with the ability to uncover underlying facts & complex relations in data,
- Ability to handle complexities, appreciate interdependencies and understand impact/benefits you can produce across projects and initiatives within programs