Biomarker Operations Manager

Kelly Science and Clinical FSP is currently seeking a Biomarker Operations Manager for a long-term engagement with one of our Global Pharmaceutical/Medical Device clients. The candidate will need to be near Spring House, PA and be able to go into the office possibly 1 day a week. 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, Vision, 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.Title: Biomarker Operations Manager or (Sr)Organization: Biomarker & Diagnostic Operations, Oncology DiagnosticsPosition Description:Janssen 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 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 statement 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 specifications 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 biosample collection and processing techniques and ensures methods are implemented appropriately across clinical sites to the highest of standardsDevelops presentations and presents 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: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&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

Created: 2025-03-02