Kelly Services Biomarker Trial Manager in East Hanover, New Jersey
Kelly Services is currently seeking a Biomarker Trial Manager in East Hanover, NJ to work a contract assignment of 6 months for one of our top clients. Kelly is a full-service workforce solutions provider to 98% of the Fortune 100™ companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.
Primary Responsibilities of the Biomarker Trial Manager:
Support individual clinical trial teams (CTTs) and Biomarker Sub-teams as required for all technical and operational biosample-related matters for assigned projects by liaising with internal stakeholders. Assist Study Lead by forecasting the biosample operational costs and reviewing in-voices.
Provide input on biomarker and clinical pharmacology sections in clinical trial-related (such as protocols and consents) and regulatory documents (such as INDs, IBs, etc.) under the supervision of the LF representatives.
Responsible for all clinical biosample tracking processes, including setting up laboratory procedures, tracking clinical biosamples from collection to analysis, and assisting with the relevant data management components.
With support, provide input and solutions on the ethical considerations for biosample collection and analysis for protocols and consents to ensure that all specific processes needed for approval in different countries are implemented.
With support, establish central and analysis laboratory components for assigned studies. Oversee central labs and analysis labs for clinical, biomarker and PK sample collection kits and sample logistics. Responsible for all the documentation required to set up central and analysis lab procedures.
Liaise with internal stakeholders, and the CTT to determine analysis labs for biomarkers and other clinical biosamples. Manage relationships with analysis labs and provide input into trial-specific agreements, following the standard process.
Define biosample needs for the case report forms (CRFs), in collaboration with LF representatives, Study Lead, trial data manager (TDM) and analysis labs; and for data formatting and data transfer set-up needs for samples. With support, liaise with the trial data manager (TDM) and labs for data transfer and data reconciliation
Partner with Global Correlative Science Leader (GCSL), study biostatisticians, and labs to establish biomarker analysis plan; under guidance, review transferred data to ensure quality.
Develop, with assistance, training material on the technical aspects of clinical biosample collections for the clinical sites, including study specific lab manuals and additional site and monitor training needs. May also be involved in training of monitors and site personnel.
Education and Experience Requirements of the Biomarker Trial Manager :
MSc or equivalent
2+ years of experience handling clinical samples
Familiarity with biomarker discover methodologies, assay technologies, and molecular biology
Basic knowledge of oncology or hematology
Knowledge of Good Clinical Practice
Basic knowledge of clinical trial design, and an understanding of the overall drug development process
Ability to manage competing priorities and meet timelines
Proven networking skills and the ability to share knowledge and experience with colleagues
Contract assignment, duration 6 months.
Work schedule: full-time, first shift.
Pay Rate: Determined by experience
Kelly Temporary Employee Perks:
Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchase—and the coverage is portable
Service bonus plan and Holiday pay plan, if qualified
Weekly electronic pay options
Free online training campus available
Exclusive online employee community
This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must submit your resumes to firstname.lastname@example.org . Thank you for your interest in the assignment.
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 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
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.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.