Senior Operations Consultant at Bank of America responsible for leading operational design and implementation. Resolving complex problems, delivering client support and conducting detailed metric analysis.
About the role
- Biomarker & Diagnostic Operations Leader overseeing oncology clinical sample collection and testing strategy. Collaborating with teams to ensure timely execution of clinical programs for oncology.
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
- Develops presentations and shares biomarker plan, project timelines, sample tracking/testing metrics at regular team meetings
- Manages relationships with internal and external partners to ensure on-time and quality deliverables
Requirements
- A bachelor’s degree in a scientific/ life science discipline is required.
- 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
Benefits
- medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
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