Data Management leadership on studies and take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff.
Compensation
Pay Range: $115,000-$125,000 CAD
Responsibilities
Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines.
Be accountable for all DM deliverables as assigned per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest quality, while adjusting resource allocations accordingly.
Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
Work with the Project Manager(s) or FSP Lead (or designee) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings.
Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of EDC Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental.
Lead the definition and development of scalable, secure, and robust end-to-end IoT solutions, bridging embedded systems, connectivity, and cloud platforms.
Responsibilities
Translate business and system requirements into technical architecture
Define the end-to-end architecture for IoT solutions, encompassing device hardware/firmware, connectivity layers, cloud services, data pipelines, and user interfaces
Define communication interfaces and integration strategies across subsystems
Architect IoT solutions for high performance, low latency, and efficient resource usage
Ensure compliance with safety, regulatory, and quality requirements
Requirements
BE/ME electronics background
Nice to have: ISAQB Certification
Nice to have: Professional certifications in Cloud Architecture
Lead the Rahway Bioanalytical Laboratory within Global Preclinical Development, providing scientific, operational, regulatory, and people leadership for bioanalytical activities supporting research, business, preclinical, and clinical development programs for veterinary pharmaceuticals.
Compensation
The salary range for the primary location of this role is: $142,400.00 - $224,100.00
Responsibilities
Lead the Rahway Bioanalytical Laboratory, including scientific and operational oversight, prioritization, resource planning, and delivery of project commitments.
Drive laboratory automation, digital technologies, and integrated data workflows to increase efficiency, data integrity, compliance, and scientific capabilities.
Lead and develop the Bioanalytics team through performance management, coaching, and capability building.
Oversee bioanalytical method development, qualification, validation, and sample analysis, with particular emphasis on mass spectrometry.
Ensure scientific quality, data integrity, documentation, and compliance with GLP, internal procedures, and regulatory requirements.
Requirements
Ph.D. in analytical chemistry, bioanalytical chemistry, pharmaceutical sciences, biochemistry or a related scientific discipline
Master's degree in a relevant scientific discipline
Lead the Rahway Bioanalytical Laboratory within Global Preclinical Development, providing scientific, operational, regulatory, and people leadership for bioanalytical activities supporting research, business, preclinical, and clinical development programs for veterinary pharmaceuticals.
Compensation
$142,400.00 - $224,100.00
Responsibilities
Lead the Rahway Bioanalytical Laboratory, including scientific and operational oversight, prioritization, resource planning, and delivery of project commitments.
Drive laboratory automation, digital technologies, and integrated data workflows to increase efficiency, data integrity, compliance, and scientific capabilities.
Lead and develop the Bioanalytics team through performance management, coaching, and capability building.
Oversee bioanalytical method development, qualification, validation, and sample analysis, with particular emphasis on mass spectrometry.
Ensure scientific quality, data integrity, documentation, and compliance with GLP, internal procedures, and regulatory requirements.
Requirements
Ph.D. in analytical chemistry, bioanalytical chemistry, pharmaceutical sciences, biochemistry or a related scientific discipline
Master's degree in a relevant scientific discipline
All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Associate Director, Bioanalytics - Global Preclinical DevelopmentMerck · Rahway, US