Life Sciences R&D Consultant

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Overview

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OtherConsultant

Deep understanding of Life Sciences/BioPharma R&D processes.
Familiarity with clinical trial systems, regulatory submission tech, patient safety reporting platform, and any modern tech solutions to accelerate drug development.
Strong stakeholder engagement and team leadership capabilities.
Ability to develop strategic perspectives and thought leadership on industry trends, digital transformation, and innovation in R&D.
Excellent communication, interpersonal, and analytical problem-solving skills

Responsibilities

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Requirements gathering and defining acceptance criteria, to align with the organization's specific needs and business processes.
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Ensuring data integrity and efficient workflows.
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Ability to provide insightful, deal-relevant points of view and recommendations based on robust analysis.
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System documentation as per GxP-compliant SDLC process
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Deliver end-user support, training, and change management to ensure successful technology adoption.
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Monitor platform updates and manage system upgrades or enhancements as needed.
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Ensure alignment with industry best practices and regulatory expectations for technology enablement in R&D.

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Requirements

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In-depth understanding of Life Sciences R&D functions including Clinical Operations, Regulatory Affairs, Quality Assurance, Safety, and related compliance requirements (GxP, 21 CFR Part 11).

Demonstrated ability to manage multiple concurrent projects, prioritize tasks, and deliver outcomes in a fast-paced environment with multiple stakeholders.

Proven ability to effectively plan, manage, and coordinate multiple projects in a dynamic environment with numerous and complex stakeholder groups.

Excellent documentation skills and exposure to work within GxP-validated systems.

Experience in at least 4-5 of the following areas:

Clinical Trial Management Systems (CTMS)
Regulatory Information Management (RIM)
Electronic Trial Master File (eTMF) or Clinical Document Management
Clinical Data Management / EDC
Biostatistics or Clinical Data AnalyticsLaboratory Information Management Systems (LIMS)
Quality Management Systems (QMS)
Pharmacovigilance or Safety Systems

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