Ref #: 28398

Employment type: Permanent - Full-Time

Location: England and Wales

Posted: 14-Apr-2021


Our Client, a global pharma, voted the most Admired companies to work for 2021, is now looking for a Operations Manager to join their Digital Health team.

You will have the responsibility for implementation and maintenance of digital health systems supporting clinical development activities within the Global Development department. The incumbent will be required to provide subject matter expertise in system implementation, validation, maintenance and issue escalation. In addition, it includes participation in/lead operational strategy projects.
The services require to work closely with other team members to ensure system impact is assessed and mitigation strategies are in place where applicable. A clear understanding on the needs of clinical trials/programs and internal or external stakeholders.

System Support
• Follow-up and support releases for the technologies/systems in use
• User acceptance testing to be performed for each respective technology/vendor systems in use
• Identify/write system test scripts with the highest quality
• Review of System Development Lifecycle (SDLC) documentation, as applicable
• Evaluate Change Control Plan/Report as appropriate in close collaboration with IT
• Support system UAT automation where needed
• Work with IT to re-test defects after a fix has been applied, including regression testing
• Support integrations landscape and validation needs
• Support vendor oversight, which can include incident/problem management, device provisioning follow-up and escalate as needed.
o Systems audit experience
System Operational Strategy
• Participate in strategy projects implementing new solutions
• Ensure implementation follows the landscape strategy
• Create and review documentation requirements
• Interact with key internal and/or external stakeholders
• Align and support system requirements
• Interact with Business and obtain the Business Scenarios.
Complies with relevant training requirements.
• Protect the rights of others; protect privacy and company assets, particularly information as the key asset.
• Maintain adequate communication with relevant parties within and outside the company
• Regularly update information in applicable systems and templates.
• Contribute to the development and improvement of departmental procedures and processes and templates in the scope of the company’s effort towards continuous quality improvement.
• Maintain quality standards and timelines that are consistent with business needs.
• Organize multiple complex priorities and projects and use a range of techniques to identify and resolve trial-related problems
• Change management – understand how to cope with change and influence/motivate others to deal with change

Education and Experience:

• Bachelor’s degree (University degree) or equivalent education required; advanced degree preferred.
• At least 2-3 years of operational experience in clinical trials with a pharmaceutical company and/or a CRO is required.
• Demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning is required.
• Demonstrated knowledge of industry best practices for vendor management is required.
• Good understanding of the therapeutic areas where J&J is involved is required.
• Experience with self service provides, digital platforms and technologies is preferred.
• Strong IT skills in appropriate software and company systems.
• Demonstrate a passion for digital technologies and how these are implemented in clinical studies
• Excellent in speaking and writing in English. Effective communication skills, oral and written.
• Good presentational and motivational skills

Please note you must already be located in UK and have a valid right to work in the UK without the need of sponsorship.

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