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Biosample Operation Manager

Your role:

The Biosample Operations Manager (BOM) will act as the SME for all biological samples collected during the clinical trial. You will be responsible for the Biosample operational implementation and execution of the translational medicine strategy (e.g. Biomarker/CDx, PK, ADA) in an assigned clinical trial. You will also maintain a patient focus to balance the value of samples versus the complexity of collection, cost to the trial and potential affects upon patient recruitment and burden. You will be responsible for overseeing the business process of Biosample lifecycle  to ensure that the samples are collected, processed, analysed and stored with the highest degree of quality and according to applicable regulations. You will review and provide input regarding operational feasibility for relevant clinical documents and/or answering regulatory questions concerning operational activities. You'll act as single point of contact regarding all Biomarker/PK/ADA operational aspects within the Clinical trial team. You will manage the interface between GCO, non-GCO functions and External partners (e.g. CRO, Analytical Labs) to ensure proper planning and cross-functional alignment on deliverables and timelines.

 

Who you are:

Minimum Qualifications:

  • Bachelor’s degree in Biology, Pharmaceuticals or other Science discipline with 3+ years of experience in clinical operations, or Master’s degree in Biology, Pharmaceuticals or other Science field
  • Excellent command of English language (verbally and in writing); other language(s) is a plus

 

Preferrred Qualifications:

  • PhD in Biology, Pharmaceuticals or other Science discipline strongly preferred
  • 4+ years clinical operations experiences and a minimum of 2+ years experiences with clinial Biomarker/Biosample processes
  • Certification in Clinical Research or Bachelor or Master degree in Clinical Research/Clinical Trial Management
Job Requisition ID:  211800
Location:  Billerica
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.


Nearest Major Market: Boston

Job Segment: Manager, R&D, Medical Research, Clinical Research, Management, Research, Healthcare

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