Specialist - Biosample Strategy & Operations

Posted 18 Nov 2022

Bangalore, Karnataka - India

Req Id 258455

Work Your Magic with us! 

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.

 


Expert 2.1: Specialist Biosample Operations

 

Your role: an exciting opportunity has arisen to join our healthcare business to support the development of first and best in class specialty medicines for our patients in need. You will work in a group, that provides support for study teams of Phase I - Phase IV (interventional & non-interventional) and Investigator Sponsored Studies. As a Specialist Biosample Operations, you will manage activities within a dedicated Center of Excellence for operational deliverables of Clinical Studies with interactions of multiple cross functional Biopharma functions and CROs.

Your main responsibilities would be:

 

  • Manage set up and maintenance of studies in the Biosample Information database in collaboration with Biosample Operation Lead (BOL) assigned to the clinical study.
  • Supports Biosample Operation activities by proof reading site training materials and biosample handling instructions in regard to Biomarker/Biosample operational aspects.
  • Review sample inventories and reports provided by central laboratory.
  • Perform quality checks on patient consent attribute log files.
  • Maintains oversight of sample reconciliation against consent (ICFs) and eCRF data by checking report received from clinical CRO.
  • Checks that clinical biosample operation, clinical biomarker and PK/ADA relevant documentation(s) are filed in eTMF
  • Assist the Biosample Operations Lead and Bioanalytical Operation Manager (BAOM) in preparation of audits and inspections, retrieve documents from CRO.
  • Supports Bioanalytical Operations Manager in managing invoice processing & tracking (incl. Purchase Order, Payment Tracking & Reporting) for bioanalytical vendors.
  • Manage Document Management System (Veeva Vault). Uploads & approval flows for bioanalytical reports.
  • Track bioanalytical lab performance (KPI, timelines).
  • Support production of critical reagents, organize shipment to CRO and maintain inventory.
  • Supports study closure activities related to Biosample disposal / relocation to biorepository.
  • Maintains and continually updates knowledge of applicable Policies, Quality Documents, conventions, tools, templates, instructions, Good Clinical Practice (ICH-GCP), applicable national regulation and ensures implementation for the conduct of the tasks.
  • Communicate knowledge and lessons learned from trial within the organization, support development and dissemination of best practices in trial management.

 

 Who You Are:

  • 4+ years clinical operations experiences
  • Certification in Clinical Research or Bachelor or master's degree in clinical research/Clinical Trial Management is preferred
  • Requires operational experience in relevant disciplines and project management experience. Requires knowledge and experience in own discipline.
  • Excellent command of English language (verbally and in writing)
  • Proven experience in working in an international/ multicultural cross functional matrix environment.
  • Good understanding of the policies and procedures of Clinical Operations and of ICH-GCP
  • Attention to details, analytical thinker & problem solver.
  • Good administrative, coordination and problem- solving skills.
  • Good time and priority management, ability to work efficiently under pressure.
  • Strong computer skills including knowledge of MS Office™ (Excel™, Word™, PowerPoint™), Outlook and Teams

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

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