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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Precision Medicine Associate- FSP
Job ID R0000036525Parexel 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
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