Biomarker Operations Manager (Remote Capabilities)

Employer
Medasource
Location
Remote
Posted
Feb 19, 2021
Required Education
Bachelors Degree
Position Type
Full time

Biomarker Oncology Operations Manager

Spring House, PA (remote due to COVID-19)

The Biomarker Operations Manager is accountable to oversee the implementation of biomarker strategic objectives as directed by the Biomarker Lead. This position is accountable for management of all biomarker sample logistics within clinical trials from study start-up to study closure to ensure that all regulatory and organizational requirements are met. Key responsibilities include budget and contract management, sample and results management and creation of study documents and presentations.

Key Responsibilities:

  • Contribute to the creation of the biomarker plan from an operational standpoint
  •  Work effectively with procurement to set up the contract and statement of work and subsequently manage the budget and oversee the delivery of contract milestones by the vendor
  • Contribute to the preparation of clinical documents such as protocols, clinical study reports, lab manuals, informed consent forms, sample management plan, early development plans and training
  • Develop presentations for status updates, program approval meetings and investigator meetings, as required
  • Accountable for biomarker sample management including vendor oversight to ensure sample quality, timeliness and tracking
  • Working under direction of the biomarker lead, evaluate and implement new assays and relevant technology as required by the program
  • Manage relationships with key vendors to ensure on time and quality deliverables, as contacted
  • Ability to effectively and collaboratively work on global cross-functional teams

Qualifications:

  • 6-8 years of work experience
  • Strong knowledge and understanding of clinical research, ICH GCP, GLP required
  • Excellent written and verbal communication skills
  • Experience working in biomarker operations
  • Experience working in a matrix environment
  • Minimum of a bachelor’s degree, scientific discipline preferred