Senior Manager, R&D Training Specialist

4 weeks ago

Cambridge, Massachusetts, United States Proclinical Staffing Full time
Job Title: Senior Manager, R&D Training

Proclinical Staffing is seeking a Senior Manager, R&D Training to co-manage a global GxP Training Program at a well-known biotech company. This hybrid role involves both on-site work in Cambridge, MA, and remote work.

Key Responsibilities:
  • Maintain a compliant GxP Training Program in line with US and International guidelines.
  • Manage and validate the electronic learning management system (Veeva Training Vault).
  • Own and update training SOPs and materials.
  • Design and deliver quality/regulatory compliance training.
  • Collaborate with functional areas to identify training roles and curricula assignments.
  • Serve as the primary contact for GCP, GCLP, GVP, and GRP training needs.
  • Ensure compliance with global regulations and internal training policies.
  • Manage training matrices, role-based training, and curriculum requirements.
  • Design and deliver various training formats, including CBT courses and microlearning videos.
  • Align training operations with R&D and Technical Operations organizations.
  • Support the GLP training team at the Gene Therapy Center of Excellence.
  • Conduct annual curricula reviews and manage new hire QMS training.
  • Utilize and support the Veeva Training Vault LMS.
  • Perform periodic assessments and escalate issues as needed.
  • Verify KPI results and drive on-time training completion.
  • Provide cross-functional support and participate in company initiatives.
Requirements:
  • Bachelor's Degree or higher in a scientific discipline preferred.
  • Expertise in GCP regulations and ICH E6(R2); additional GCLP/GLP/GVP/GRP experience a plus.
  • Experience designing and delivering GxP training and creating eLearning materials.
  • Proficiency with electronic Training Learning Management Systems, preferably Veeva Training Vault.
  • Strong computer skills, particularly with MS Office Products.
  • Ability to identify continuous improvement opportunities and drive innovation.
  • Strong team player with a track record of success in cross-functional teams.
  • Ability to work independently with minimal oversight.
  • Excellent communication, presentation, and adult learning skills.
  • Strong organizational, computing, and oral/written communication skills.
  • Ability to influence and negotiate effective solutions.
  • Strong critical thinking and decision-making skills.
Compensation:
  • USD 165,000.00 - 170,000.00 per annum

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