Product Manager - Digital Clinical Applications
Posted on Nov 7, 2020 by Red - The Global SAP Solutions Provider
Product Manager - Pharmaceutical experience essential - Digital Clinical Applications
Out client is looking for a Product Manager with experience working with Digital Clinical Applications. The role will be based near Brussels, and will be worked remotely initially but they need people who can work in Brussels once the situation allows. 12 month extendable contract.
Description of the work:
The requested product manager will be responsible for multiple product lines within the product suite of the platform. His/her scope will comprise the full life cycle of digital clinical products including vision, requirements, deployment, and optimization.
- To facilitate the definition and prioritization of requirements, systems enhancements, and process improvement from user communities by leading systems management teams and regularly communicating with key stakeholders for the product area.
- To partner with project managers to ensure that requirements are fulfilled, and the launch of the product or enhancement is successful.
- To participate in and develops stakeholder communications, user training, and product demonstrations.
- To develop product materials and collateral to increase internal and external adoption of systems and processes.
- Ability to draft, review, finalize user requirement and functional specifications
- To support/understand the overall agile SDLC, Testing, and validation processes
- To coordinate resolution & risk mitigation of all ePRO/eCOA-related issues and end-of-study vendor deliverables
- To write/update SOPs and develop a library of ePRO data capture and reporting standards, as needed
- As required, to work with Vendor PMs to maintain timelines and determine external potential risks
Ideal Candidate Prerequisites:
- Minimum of 5 years of experience as a product manager
- 3 to 5 years working on clinical studies
- Experience with EDC systems is a plus
- Experience with 21 CFR Part 11 and GcP
- Experience MHRA and other regulatory agencies
- Experience with electronic Clinical Outcome Assessment (eCOA) and/or electronic Patient-Reported Outcome (ePRO)
- Experience with study protocol analysis, including requirements extraction for COA builds and creation/implementation of study design plans
- Demonstrated success defining and launching products