26 days old

REMOTE Biomarker Sample Manager

Kelly Services
Cambridge, MA 02238 Work Remotely
**Kelly Services** is currently seeking a REMOTE **Biomarker Sample Manager** to work a contract assignment 6 **month duration** 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 includes:**

The Clinical Biomarker Innovation and Development group is seeking an outstanding candidate who will effectively execute the clinical study start up process across all therapeutic areas.

The incumbent will work in close partnership with the clinical biomarker, diagnostics and bioanalytical sciences groups within CBID, clinical science & operations, drug discovery & data standards within the company, as well as external partners.

As a Clinical Biomarker Sample Manager, the candidate will be responsible for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of patient samples.

Coordinate and drive completion of sample management plans for all clinical trials supported by CBID.

Review key study start up documents such as clinical study protocols, requests for proposals for central laboratory services, budgets, contracts and laboratory manuals to verify that biomarker samples are collected as specified in the sample management plan.

The candidate will be responsible for developing and executing the bioanalytical and biomarker operations and companion diagnostics plan for programs, including scenario planning, high level forecasting of timelines, assessment of program level feasibility, estimation of budget and resources (in collaboration with the CBID scientists and other key internal partners) and development of high level operational strategies.

Coordinate assigned clinical studies and programs by planning for and managing timelines for various deliverables and facilitate communication between CBID scientists and CRO labs as well as negotiate and ensure all high priority timelines for data delivery and reports are met.

Work closely with Translational Lead Scientists and Bioassay Scientists to develop data transfer specification documents that ensure complete and accurate delivery of clinical biomarker data.

Interfaces with clinical project teams to mitigate issues with clinical biomarker data standards.

Interfaces with vendors to mitigate issues with clinical biomarker data transfers and reporting.

Oversee finalization of data transfer agreements (DTA) and ensures that data is transferred between bioassay vendors and CRO to meet clinical trial and translational timelines.

Responsible for creating effective biomarker sample collection language in model patient informed consent forms and for review of changes made during the IRB/EC approval process

Work closely with key line functions such as Legal, Clinical Operations, Clinical Outsourcing and outside vendors to identify and provide solutions to issues regarding biomarker sample collection in clinical trials

Responsible for documentation, SOPs and protocols related to biomarker samples.

Utilize vendor tracking systems in order to report progress, address issues and resolutions.

Address questions and requests from CRO or clinical team on sample collections, shipment to vendor for testing, analysis and final disposition.


BS or MS in life scientific discipline with 2-8 years of biotechnology or pharmaceutical industry experience in drug development and clinical trial project management.

Excellent knowledge of clinical trials and understanding of the role of biomarkers in clinical studies

Familiarity and experience with CDISC/SDTM and related industry standards

An understanding of various biomarker assay platforms (NGS, IHC, Flow Cytometry, etc.) is highly desirable

Works successfully under pressure and with tight timelines.

Self-motivated, highly independent, organized & detail-oriented

Excellent written, organizational and interpersonal communication skills necessary to interface with outside vendors and internal team members across function areas.

Technical knowledge to maintain electronic files and experience with LIMS database systems.

Microsoft Office proficiency


**For immediate consideration please send your resume to**

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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.



Posted: 2020-10-05 Expires: 2020-11-05

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REMOTE Biomarker Sample Manager

Kelly Services
Cambridge, MA 02238

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