JUMP TO CONTENT
Shortlist
search jobs Search
About the role ICON and you Application Process Day in the life Who we are

Biosample/Biomarker Operational Manager

  1. Germany, Spain, UK
2023-106325
  1. Clinical Monitoring
  2. ICON Strategic Solutions

About the role

This vacancy has now expired. Please click here to view live vacancies.
  • Is responsible for the Biosample operational implementation and execution of the translational medicine strategy (e.g. Biomarker/CDx, PK, ADA) in an assigned clinical trial
  • Maintains 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
  • Is 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
  • Is responsible for reviewing and providing input regarding operational feasibility for relevant clinical documents and/or answering regulatory questions concerning operational activities
  • Is acting as single point of contact regarding all Biomarker/PK/ADA operational aspects within the Clinical trial team
  • Is responsible for managing 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

  • Provides clinical operational feasibility input during pre-clinical phase (e.g. from DPED/DP0) in alignment with the Biosample Operations Lead to facilitate TxM strategy implementation into clinical settings
  • Participate to the preparation and review of the core protocol, clinical study protocol and ICF to guarantee that collection, analysis rationale and feasibility of biological sampling are conducted according to the operational plan and in alignment with regulatory guidance
  • Set-up the Central Lab activities, oversee and contribute to documentation preparation (e.g. LES, LSD, SOW, lab Manual etc..) and materials (e.g. kit contents) to ensure proper biosample handling in alignment with the operational plan
  • Supports clinical trial management activities by reviewing and providing input to site questionnaire, site training materials, EDMCP, FlowChart in regards to Biomarker/Biosample operational aspects
  • Plans, organizes and oversees central lab activities including collection and shipping of biosamples from investigator sites or Central Labs and their subsequent delivery to assay laboratories to ensure timely delivery and optimal analyzable quality
  • Maintains oversight of all study biosample operational activities and regularly report on status including sample collection, quality and reconciliation against consent (ICFs) and eCRF data.

  • Minimum of three (3) years of clinical operations experience in Biomarker or Biosamples related fields in global clinical trials in CRO or Pharmaceutical organization
  • Requires operational experience in relevant disciplines and project management experience. Requires knowledge and experience in own discipline
List #1

Day in the life

A picture of Debora Oh
How to excel as a CRA in a Clinical Research Organisation

Teaser label

Our People

Content type

Blogs

Publish date

08/29/2023

Summary

To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her

Teaser label

Brazil-based CRA II Debora Oh shares her tips on how to become a great CRA and provides insight into life at ICON.

Read more
A picture of Yemi Moses
Progressing as a CRA with ICON

Teaser label

Our People

Content type

Blogs

Publish date

05/23/2023

Summary

How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to excell

Teaser label

 Senior CRA Yemi Moses recounts her development and shares her career ambitions with ICON plc.

Read more
A picture of Suzaita
Suzaita's story - an insight into working in Clinical Research

Teaser label

A Day In The Life

Content type

Blogs

Publish date

04/05/2023

Summary

Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfilled?

Teaser label

Senior Clinical Research Associate, Suzaita Hipolito, talks about how working in Clinical Research gives her happiness and fulfilment.

Read more
Suzaita Hipolito

by

Suzaita Hipolito

Suzaita Hipolito

by

Suzaita Hipolito

View all

Similar jobs at ICON

Senior CRA

Salary

Location

Poland

Department

Clinical Monitoring

Location

Poland

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a Senior CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-119578

Expiry date

01/01/0001

Read more Shortlist Save this role
Read more Shortlist Save this role
CRA II

Salary

Location

Poland

Department

Clinical Monitoring

Location

Poland

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a CRA II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-119576

Expiry date

01/01/0001

Read more Shortlist Save this role
Read more Shortlist Save this role
CRA II

Salary

Location

Poland

Department

Clinical Monitoring

Location

Poland

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a CRA II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-119575

Expiry date

01/01/0001

Read more Shortlist Save this role
Read more Shortlist Save this role
CRA II

Salary

Location

Poland

Department

Clinical Monitoring

Location

Poland

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a CRA II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-119577

Expiry date

01/01/0001

Read more Shortlist Save this role
Read more Shortlist Save this role
Senior CRA

Salary

Location

United States

Department

Clinical Monitoring

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-119660

Expiry date

01/01/0001

Melissa Benner

Author

Melissa Benner
Melissa Benner

Author

Melissa Benner
Read more Shortlist Save this role
Read more Shortlist Save this role
Senior CRA

Salary

Location

Canada, Burlington

Department

Clinical Monitoring

Location

Burlington

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Senior Clinical Research Associate (CRA)/ CRA II to join our diverse and dynamic team. As a Senior CRA/ CRA II at ICON Plc, you will play a critical role in overseeing and m

Reference

JR129333

Expiry date

01/01/0001

Zach Hines

Author

Zach Hines
Zach Hines

Author

Zach Hines
Read more Shortlist Save this role
Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above