Biomarker Operations Manager

Title: Biomarker Operations ManagerOrganization: Biomarker & Diagnostic Operations, Oncology Precision Medicine & DiagnosticsPosition Description: Our client is seeking a highly motivated individual to join the Oncology Biomarker & Diagnostic Operations team. As a key contributor to the clinical biomarker and diagnostic strategy, he/she will be accountable for the 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 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 biosample 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:• A Bachelor 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 teamsCompensation:$50-80/hrExact compensation may vary based on several factors, including skills, experience, and education.Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.