GENETICS AND BIOMARKER MANAGER / 40 HOURS / DAY / BWH
GENETICS AND BIOMARKER MANAGER / 40 HOURS / DAY / BWH - TIMI STUDY GROUP
Responsibilities: GENERAL SUMMARY / OVERVIEW STATEMENT: The incumbent is responsible for overseeing all operational aspects of the genetics and biomarker core services at the TIMI Study Group, as detailed below. The position has responsibility for ensuring that the TIMI Study Group meets all operational goals/regulatory responsibilities for these core services it provides for clinical trials and for facilitating the completion of scientific projects. PRINCIPAL DUTIES AND RESPONSIBILITIES: TIMI Genetics and Biomarker Manager Responsibilities (in conjunction with the Biomarker and Pharmacogenetics Core Laboratories Medical Directors): 1. Support development of proposals and budgets for new biomarker and genetic studies. 2. Oversee operational planning for receipt, inventory, and storage of genetic and biomarker samples. 3. Supervise tracking of receipt and inventories of genetic and biomarker samples for each TIMI trial and maintain a database to track sample locations, status, and volumes. 4. Manage development of pull-lists and transfers of samples for individual projects. 5. Assist in sample processing plans and project designs. 6. Participate in data quality assurance. 7. Assist in oversight of timelines for ongoing and future genetics and biomarker projects. 8. Ensure compliance with all relevant regulatory mandates. 9. Oversee development and execution of all TIMI Standard Operating Procedures (SOPs) related to Biomarker and Genetic Core Laboratories. 10. In conjunction with trial PIs, provide support for drafting informed consent language relevant to collection of biosamples, reviewing proposed changes to such language, and other needed responses to ethics committees or regulatory authorities associated with submission of genetic and biomarker protocols across each clinical trial. 11. Support the development of protocols, study materials, and IRB submissions for biomarker and genetics-focused studies. Requirements: QUALIFICATIONS: 1. Minimum of Bachelor?s degree, appropriate scientific background. 2. Two (2) to three (3) years of related experience. 3. Experience with computers and data management systems. SKILLS / ABILITIES / COMPETENCIES REQUIRED: 1. Ability to accept a high degree of authority and responsibility for decision-making as it relates to the conduct of the genetic and biomarker services. 2. Appropriate scientific background to understand key issues relating to genetic and biomarker studies. 3. Excellent management skills to ensure successful acquisition and transfer of samples and to follow projects through to completion. 4. Outstanding organizational abilities to formulate and complete rigorous timetables. WORKING CONDITIONS: Clinical/research office environment with extended hours as needed to meet project deadlines. SUPERVISORY RESPONSIBILITY: None FISCAL RESPONSIBILITY: In conjunction with the TIMI Chairman, the Director of Finance, and the Directors of the Biomarker and Genetics Core labs, the Manager is responsible for assistance with the TIMI Study Group budgets as they pertain to the genetics and biomarker projects. Shift: Day Shift EEO Statement: An EEO, AA, VEVRAA Employer