Biomarker Operations Manager
mykellySpring House (PA)
About the role
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 inSpring House, PAorCambridge, 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 oncologyCreates and manages biomarker and diagnostic plan, timelines, budget, risk assessments and quality metrics during study startup, conduct and closeoutWork effectively with procurement and scientific leads to execute contracts and statements of work to meet program deliverablesContributes to central lab setup and management throughout the course of a studyManages relationships with specialty testing vendors to ensure biomarker/diagnostic samples are processed, tested and data is reported to meet development timelines and specificationsWorks closely with data management to establish data collection and transfer processes with testing vendors and local labsContributes 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 materialsWorks 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 standardsDevelops presentations and shares biomarker plan, project timelines, sample tracking/testing metrics at regular team meetingsMay work with scientific stakeholders to evaluate and implement new assays and relevant technologies as required by the programManages relationships with internal and external partners to ensure on-time and quality deliverablesParticipates 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&DStrong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP requiredProject management experience is preferredKnowledge of oncology drug development and/or biomarker/diagnostic development is preferredExcellent written and verbal communication skillsAbility to effectively and collaboratively work on global cross-functional teams
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