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Product Manager (Pharma - Digital Clinical Applications - EDC, 21 CFR,

Octopus Computer Associates

Posted on Nov 11, 2020 by Octopus Computer Associates

Not Specified, Belgium
IT
Immediate Start
Annual Salary
Contract/Project


Product Manager (Pharma - Digital Clinical Applications - EDC, 21 CFR, GcP ) - Remote and Belgium

(Pharma, Pharmaceutical)

One of our Blue Chip Clients is urgently looking for a Product Manager.

For this role you can work remotely (from home) and then onsite in Belgium may be required once COVID safe.

Please find some details below:

Job Posting Title: Product Manager

Description: Title/Role: Product manager of Digital Clinical Applications

Description of the work: The requested product manager will be responsible for multiple product lines within the product suite of the customer platform. His/her scope will comprise the full life cycle of digital clinical products including vision, requirements, deployment, and optimization.

Responsibilities

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

Bachelor's degree (MBA is a plus)

Excellent written and verbal communication skills

Excellent business and technical stakeholder management skills

Experience in software product definition and development, especially on mobile/cloud applications

Proven ability to influence cross-functional teams without formal authority

Excellent teamwork Skills

Please send CV for full details and immediate interviews. We are a preferred supplier to the client.




Reference: 1002700566

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