• The Kemtah Group
  • Whippany , NJ
  • Non-Executive Management
  • Full-Time

A Biosample Operations Manager Support job located in Whippany, NJ is currently available through Belcan. The Biosample Operations Manager plans and coordinates all operational activities for the collection, handling, storage and delivery of biomarker, pharmacogenetic, immunogenicity and pharmacokinetic samples (in following: biosamples) within Phase I to III clinical study, while being simultaneously assigned to multiple studies

Biosample Operations Manager Support job duties:

Plans, organizes, monitors and enforces the collection, processing, storage and logistics of Biosamples within a study

Accountable for preparation of study related documents (biosample management plan, laboratory manual, sample handling sheets etc.) as well as development of shipment schedules, sampling and storage requirements in close collaboration with central and analytical laboratories

Responsible for handling of samples according to protocol, SOPs, GCP and ICH-guidelines.

For Phase 1 studies, initiates the contracts with the biosample management central laboratory and will be responsible to support the forecasting of the cost and tracking the budget of these contracts in the respective studies

Training of monitors, study nurses and investigators

Supports the study team with the submission to IRBs and ECs and responds to IRB/EC requests

Responsible for the tracking, monitoring and documentation of biosampling activities

Qualifications:

Post-graduate degree in Life Sciences (MSc, PhD)

3 years experience in clinical research, with detailed understanding of clinical development processes (e.g. study management or CRA)

Detailed knowledge of the ethical, legal and logistic requirements of obtaining and processing human blood and tissue samples

Proven clinical development experience of working in teams running clinical studies (study management), monitoring clinical studies or experience of working in clinical studies at an investigator site

Good knowledge of BM and PK analytical processes

Proven ability to plan, organize and manage multiple projects under pressure

Proven ability to successfully achieve results within a multi-cultural and geographically diverse team

Effective communication and negotiation skills in English

Travel Requirements:

0-5%, depending on projects needs

If you are interested in this Biosample Operations Manager job in Whippany, NJ, please apply via the apply now link provided.

Belcan is a global supplier of engineering, technical recruiting, and IT services to customers in the aerospace, industrial, and government sectors. Belcan engineers better outcomes through adaptive and integrated services - from jet engines, airframe, and avionics to heavy vehicles, chemical processing, and cybersecurity. Belcan takes a partnering approach to provide customer-driven solutions that are flexible, scalable, and cost-effective. Our unique capabilities have led to continuous growth and success for nearly 60 years. We are a team-driven Equal Opportunity Employer committed to workforce diversity.

Associated topics: cultivate, fertilize, fork lift, manage, management, plant, plant management, prune, ship, watering

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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