Biomarker Operations Manager

Title: Biomarker Operations Manager or (Sr)

Organization: Biomarker & Diagnostic Operations, Oncology Diagnostics

Position Description:

Kelly FSP is seeking a highly motivated individual to join the Biomarker & Diagnostic Operations team with our pharmaceutical client. 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, risk assessments and quality metrics during study startup, conduct and closeout
• Works 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 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:

• 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