Kelly Science and Clinical FSP is currently seeking a Biomarker Operations Manager to support our pharmaceutical partner. 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 will be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.
This position is in Spring House, PA or Cambridge, MA
We are seeking a highly motivated individual to join the Oncology Biomarker & Diagnostic Operations team. As a key contributor to the clinical biomarker and diagnostic strategy, this individual will be accountable for the implementation and execution of clinical sample collection, testing and data delivery activities for both early and late phase clinical programs in oncology. The successful candidate will have experience bridging both science and operations through 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 statements 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 processes 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 shares biomarker plan, project timelines, 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:
A bachelor's degree in a scientific/ life science discipline is required. Additional qualifications: e.g. MS, PhD and/or project management certification desirable.
5+ years of work experience in clinical development, and/or biomarker or diagnostics development 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
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job @type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
