BioSpace · 2 days ago

Manager - CMR Knowledge & Technical Advancement

Plainsboro, NJ

Full-time

Onsite

Senior Level

8+ years exp

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Comp. & Benefits

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Responsibilities

Develop role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other regulatory requirements.

Collaborate with functional CMR stakeholders to develop, deploy, and archive functional and role-based training material.

Identify training needs within CMR function; Assess training gaps and identify role-specific learning requirements (SOPs, internal processes, etc.) in partnership with CMR Subject Matter Experts.

Collaborate with internal and external stakeholders, both locally and globally, to seek alignment and share resources across multiple groups.

Ensure CMR employees receive training on regulatory compliance, quality standards, GxP requirements and industry-specific guidelines as they pertain to their roles.

Identify and address specific technical competency/skill gaps across CMR, developing training strategies to close the knowledge gaps (for example: New TA knowledge, New Trial/Protocol etc.).

Collaborate with Subject Matter Experts to ensure that training programs/initiatives align with the latest industry trends, regulations, and best practices.

Facilitate the transfer of critical knowledge and expertise from experienced personnel to new employees, ensuring the preservation and dissemination of institutional knowledge.

Serve as the CMR Training representative; Liaise with global and HQ counterparts to promote quality and consistency across regions.

Ensure compliance with SOPs, KPIs, internal processes; Track and measure specific CMR technical metrics.

Qualification

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Clinical DevelopmentClinical TrialsCoaching Clinical Practice (GCP)ICH GuidelinesProblem-SolvingCustomer FocusCommunicationCollaborationInfluencingTraining & DevelopmentOperationsLearning & Development2 years training experience

Required

A Bachelor’s degree is required.

A minimum of eight (8) years of progressively responsible clinical development/trial experience within a pharmaceutical, biotechnology, or CRO required.

Demonstrated competency in coaching and training of clinical research staff

Advanced knowledge of Good Clinical Practice (GCP), ICH Guidelines, federal and local regulations, and clinical research process

Strong solution-oriented customer focus

Good communication, collaboration and influencing skills