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Senior Biosample Operations Specialist

 

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 

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 new established group, that provides support for study teams of Phase I - Phase IV (interventional & non-interventional) and Investigator Sponsored Studies. As a Biosample Operation Specialist, 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 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 BOL and Bioanalytical Operation Manager in preparation of audits and inspections, retrieve documents from CRO.
  • Supports BAOM in managing invoice processing & tracking (incl. Purchase Order, Payment Tracking & Reporting) for bioanalytical vendors.
  • Manage Document Management System (ELDORADO) 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 and a minimum of 2+ years experiences with clinical Biosample processes
  • 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
  • Experience with Lab Management Systems

 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

We are committed to promoting a diverse and inclusive workforce. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

 

Job Requisition ID:  222821
Location:  Mumbai
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Neurology, Oncology, Laboratory, Database, Healthcare, Science, Technology, Research

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