JUMP TO CONTENT
Shortlist
search jobs Search

Our Culture Application Process AI Usage Policy Our Mission & Values

Biosample/Biomarker Operational Manager

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

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 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 fulfil

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

Clinical Research Associate

Salary

Location

United States of America

Location

Multiple US Locations

Remote Working

Remote

Business Area

ICON Strategic Solutions (FSP)

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Clinical Research Associate (CRA) to join our diverse and dynamic team. As a CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activit

Reference

JR148352

Expiry date

01/01/0001

Kala Murphy

Author

Kala Murphy
Kala Murphy

Author

Kala Murphy
Read more Shortlist Save this role
Read more Shortlist Save this role
Clinical Research Associate

Salary

Location

United States of America

Location

Multiple US Locations

Remote Working

Remote

Business Area

ICON Strategic Solutions (FSP)

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Clinical Research Associate (CRA) to join our diverse and dynamic team. As a CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activit

Reference

JR145140

Expiry date

01/01/0001

Kala Murphy

Author

Kala Murphy
Kala Murphy

Author

Kala Murphy
Read more Shortlist Save this role
Read more Shortlist Save this role
Sr. Clinical Research Associate

Salary

Location

Illinois

Location

Illinois

Remote Working

Remote

Business Area

ICON Strategic Solutions (FSP)

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.What You Will Do:

Reference

JR150997

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
Sr. Clinical Research Associate

Salary

Location

California

Location

California

Remote Working

Remote

Business Area

ICON Strategic Solutions (FSP)

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.What You Will Do:

Reference

JR150983

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
Sr. Clinical Research Associate

Salary

Location

California

Location

California

Remote Working

Remote

Business Area

ICON Strategic Solutions (FSP)

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.What You Will Do:

Reference

JR150962

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

Argentina, Buenos Aires

Location

Buenos Aires

Remote Working

Remote

Business Area

ICON Strategic Solutions (FSP)

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.What You Will Do:

Reference

JR152802

Expiry date

01/01/0001

Elizabeth Davies

Author

Elizabeth Davies
Elizabeth Davies

Author

Elizabeth Davies
Read more Shortlist Save this role
Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above