Precision Medicine Associate

Precision Medicine Associate/Senior Precision Medicine Associate

Works closely with Precision Medicine leadership and key clinical and laboratory personnel to implement and operationalize Precision Medicine goals within clinical trials, establishing clinical standards that drive quality and consistency. 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
• 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 supervision of the PMOL

Selection of Central Laboratory and Specialty Vendors

• Prepares Request for Proposal (RFP), reviews and assesses bids and statements of work
• 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 communicating and interacting with internal and external stakeholders
• 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 role specific applications (especially Microsoft Excel)
• Problem solving abilities, troubleshooting, resourcefulness, and attention to detail

Knowledge and Experience:

• Minimum of 2 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
• Oncology experience preferred

Education:

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