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12 days old

Biomarker Site Operations Manager

Kelly Services
Spring House, PA 19477
**Biomarker Site Operations Manager**


Kelly Services is currently seeking a Biomarker Operations Manager for a long-term engagement with one of our Global Pharmaceutical clients in Spring House PA, San Fran CA or possibly remote work from home.


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


**Organization:** Biomarker & Diagnostic Operations, Oncology Diagnostics


**Position Description:**


Our sponsor client is seeking a highly motivated individual to join the Biomarker & Diagnostic Operations team. As a key contributor to the clinical biomarker and diagnostic strategy, he/she will be accountable for implementation and execution of clinical sample collection, testing and data delivery activities for both early and later phase clinical programs in oncology. The successful candidate will have experience bridging both science and operations though cross functional partnerships, strategic project planning and facilitating key biomarker and diagnostic execution discussions.


**Key Responsibilities:**


+ Drives the implementation and execution of the clinical biomarker and diagnostic strategy for clinical programs in early and late-stage oncology

+ Creates and manages biomarker and diagnostic plan, timelines, budget, risk assessments and quality metrics during study startup, conduct and closeout

+ Work effectively with procurement and scientific leads to execute contracts and statement of work to meet program deliverables

+ Contributes to central lab setup and management throughout the course of a study

+ Manages relationships with specialty testing vendors to ensure biomarker/diagnostic samples are, processed, tested and data is reported to meet development timelines and specifications

+ Works closely with data management to establish data collection and transfer specifications with testing vendors and local labs

+ Contributes to the preparation of clinical documents such as clinical protocol, clinical study reports, lab manuals, informed consent forms, sample management plan, early development plans and site training materials

+ Works with scientific stakeholders to identify innovative bio sample collection and processing techniques and ensures methods are implemented appropriately across clinical sites to the highest of standards

+ Develops presentations and presents sample tracking/testing metrics at regular team meetings

+ May work with scientific stakeholders to evaluate and implement new assays and relevant technologies as required by the program

+ Manages relationships with internal and external partners to ensure on time and quality deliverables

+ Participates in cross-functions study team meetings across clinical, translational research and diagnostics.


**Qualifications:**


+ Life Science degree (Bachelor Minimum) in scientific, medical or healthcare area required. _Additional qualifications: e.g. MS, PhD and/or project management certification desirable._

+ 5+ years of work experience in a clinical development, diagnostics and/or Pharmaceutical/biotech R&D

+ Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP required

+ Project management experience is preferred

+ Knowledge of oncology drug development and/or biomarker/diagnostic development is preferred

+ Excellent written and verbal communication skills

+ Ability to effectively and collaboratively work on global cross-functional teams


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


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-06-07 Expires: 2021-07-08

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Biomarker Site Operations Manager

Kelly Services
Spring House, PA 19477

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