Biomarker Samples Manager

  • Contract
  • Pharmaceutical

Do you have an innovative mindset and do you enjoy groundbreaking work with impact on the conduct of clinical studies, this vacancy of Biomarker Samples Manager  might be your ideal next step! 

Vacancy information

The Biomarker Samples Manager is an operational expert and accountable for all operational aspects associated with piloting, implementing and/or standardizing sampling methods and procedures 

The Manager is an integral part of the Sample Management CoE and contributes to driving the methodology evolution from an exploratory phase to a standardization phase to support both biomarker research and clinical endpoints. The Manager is also responsible for training and/or implementing sampling methods in selected specialty labs and/or hospital.

Function:

• Responsible for implementing sampling methods and procedures to be performed by hospital site staff in clinical studies. You develop Lab Manual and Training Material for clinical trials ;

• Track and update the Lab Manual and other auxiliary material as appropriate and timely, such as Sample Data Sheets and Training Material.

•  For commercially available sampling and processing methodologies, you are responsible for any necessary modification/customization in the Lab Manual to support the specific needs in in-scope clinical studies.

• Oversee and follow up with external lab service providers who develop/standardize sampling methods and/or execute procedures to ensure that the vendors have the appropriate infrastructure 

• Oversee and follow up on the performance of sample management related vendors (e.g., timely delivery of high quality samples, sample meta-data and data reports) in clinical studies.

• Engage and instruct the local or central lab on the specific components of the translational sampling kits 

• Provide input to budget forecast/accrual related to sample management in clinical studies, as requested.

• Assist in presentation of sampling methods and procedures You focus on the operational aspects of the sampling procedures at the training/meetings.

• Oversee and follow through the chain of custody of the collected samples in assigned studies.

Requirements information

Education:  Master in Science 

Experience and Knowledge:

A minimum of 2 years of relevant professional experience 

Professional Experience: 

  • Hands-on research experience with biology lab methodologies for at least 2  years
  • Practical experience in managing human samples for at least 2  years
  • Practical experience in management and conduct of clinical studies for at least 2 years
  • Experience in managing projects (timelines, quality, resources) in a must
  • Experience in vendor management of laboratory services is a must

Exposure to translational research is important. Familiarity with immunology in clinical development is invaluable.  Knowledgeable in ICH-GCP and GCLP pertaining to human sample management is required. 

Having worked in a cross-functional matrix organization


Skills:

Result-oriented, problem solving, meticulous, attention to details and sense of urgency

Demonstrated ability to lead multiple assignments concurrently and to prioritize tasks effectively

Proven ability to handle complex projects and overcome delays and obstacles

Flexible and adaptable to meet business needs

Proven ability to communicate to stakeholders

Proficient in written and spoken English. 


Extra Requirement: Willingness and ability to travel and to adjust working hours to accommodate different time zones and facilitate trans-Atlantic collaborations (e.g., Asia, US), as needed

Sonia Vandekerkhove

Vacancy ID: 234

Senior Recruiter

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