Senior Precision Medicine Associate- FSP

Parexel FSP has an exciting opportunity for a Senior Precision Medicine Associate. This role works closely with line Manager, Precision Medicine, and other key personnel to implement and operationalize Precision Medicine goals within client clinical trials. Manages central laboratory and specialty vendors on low to moderately complex clinical trials. Performs other duties as necessary to
ensure optimal clinical trial execution.

Key Accountabilities:

Study Team Support

• Collaborates within cross functional study teams
• Presents at investigator meetings and creates training materials (lab manual, sample collection procedures and presentation slides)
• Manages acquisition of clinical trial samples
• Provides support for sample related matters to clinical study teams
• Works with Informed Consent Form (ICF) Specialist and Precision Medicine Operations Lead (PMOL) to ensure compliance with ICF permissions

Operational Support of Biomarker and Exploratory Analysis

• Assists PMOL with vendor selection and oversight
• Executes biomarker plans in collaboration with the study team and PMOL
• Provides input to clinical trial related documents under the supervision of the PMOL

Selection of Central Laboratory and Specialty Vendors

• Prepares Request for Proposal (RFP), reviews and assesses bids and statements of work
• Manages biomarker vendors for low to moderately complex clinical trials
• Coordinates capabilities presentations by third party vendors

Central Laboratory and Specialty Vendors Management

• Communicates with academic collaborators
• Participates in oversight activities with vendors and supports audits as required

Data Acquisition and Management

• Supports information exchange and maintains data integrity
• Provides guidance and training to clinical sites, collaborators and vendors under supervision of the PMOL
• Supports sample and data reconciliation activities

Compliance with Parexel standards

• Complies with timely completion of required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• Effective problem-solving skills with internal and external stakeholders
• Comfortable presenting to internal and external audiences
• Proficient in written and spoken English required
• Proficient in local language, as applicable, preferred
• Project management and organizational skills
• Ability to effectively multi-task and prioritize
• Ability to work in a global matrix environment
• Proficiency in widely used technologies and ability to learn client applications (especially Microsoft Excel)
• Problem solving abilities, troubleshooting, resourcefulness, and attention to detail

Knowledge and Experience:

• Minimum of 6 years relevant industry experience is required
• Science background and working knowledge of a wide array of medical terms, biological assays including proteomics, cellular assays and genomics
• Understanding of bioethics of human biospecimen collection and research
• May require oncology experience

Education:

• Bachelor of Science degree or equivalent
• Biology or equivalent major preferred

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.