Biomarker Operations Project Manager

Biomarker Operations 

 

Main Responsibilities and Accountabilities:

Provides biomarker operational expertise and guidance to global Study Management Teams (SMTs)

Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (including companion diagnostic samples), (collection, processing, analysis, data delivery process and final sample disposition)

Responsible for collaborating closely with biomarker scientists and Biomarker Operations Program Leaders (BOPLs) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internal and external stakeholders.

Develops and maintains effective working relationships with SMT members, with particular focus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors, where applicable

Builds and maintains effective and efficient high performing biomarker sample analysis & data delivery .

Supports relevant stakeholders in their accountabilities, responsibilities and deliverables to drive decisions on timelines

Responsible for the identification and selection of biomarker vendors in collaboration with the BOPL, biomarker scientist, GPPS and diagnostics/CDx managers; ensuring appropriate cross-functional input is incorporated into the scope of work

Ensure collection, delivery and analysis of biosamples under the highest standards of quality, ethics, and informed consent at study level

 

Skills & Knowledge:

Extensive clinical development experience with evidence of working in teams running clinical studies

Pharmaceutical industry experience or experience working as a clinical trial coordinator within a clinical trial setting is a plus

Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples

Project management skills

Critical reasoning skills including the identification and resolution of complex problems

Detail oriented with the ability to work independently and manage multiple competing priorities

Planning, organizational and time management skills

Highly flexible in a fast pace global matrix environment

Professional interpersonal skills, excellent oral/written communication and influencing skills

Proven leadership skills, ability to successfully achieve results within a multi-cultural and geographically diverse team

Creates team culture and promotes team spirit.

Global Vendor Management experience preferred

Good knowledge of ICH GCP Competencies

Strategic Agility; Inspiring and Influencing; Teamwork and Collaboration; Communication; Technical and Business Expertise; Achieving Results

 

Education/Qualifications:

Life sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required.

Further qualification, e.g. PhD and/or project management certification is desirable.

3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

 

Required Skills:

COLLECTION

CRO

DETAIL ORIENTED

DIVERSE TEAM

GCP

Additional Skills:

ICH

LEADERSHIP SKILLS

OPERATIONS

PROJECT MANAGEMENT

PROJECT MANAGER

SMT

TIME MANAGEMENT

VENDOR MANAGEMENT

BIOTECHNOLOGY

CLINICAL RESEARCH

CLINICAL STUDIES

CLINICAL TRIAL

LABORATORY

LIFE SCIENCES

SURFACE MOUNT TECHNOLOGY

 

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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