Precision Medicine Operations Lead

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Works with Precision Medicine Strategy Lead as well as clinical study teams to ensure quality samples and data are delivered to support biomarker evaluation and delivery of science to medicine.  Responsibilities include oversight of clinical sample collection, usage per informed consent form, sample tracking (chain of custody) and sample destruction. Individual will work closely with internal and external groups/vendors to manage and support the generation of quality biomarker data. Will work closely with clinical sites and project managers (central and/or specialty laboratories) to ensure samples are collected per protocol and to resolve any sample related issues or queries. Additional responsibilities include overall project/portfolio management and alignment amongst studies.

Key Accountabilities:

Accountability

Supporting Activities

Compliance with Parexel standards

• Comply with timely completion of required training curriculum
• Complete timesheets accurately as required (weekly)
• Submit expense reports as required (within 30 days)
• Update CV as required
• Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements

Study Team Support

• Participates in cross-functional study teams and sub-teams across clinical and research sides of the company
• Works with clinical study team on the development of the ICF, including escalations from IRBs/ECs
• Manages acquisition of clinical trial samples designated for biomarker research (including human tissue, whole blood, plasma, serum, etc)

Operational Support of Biomarker and Exploratory Analysis

• Establishment, oversight, planning, and integration of all issues related to bio sample processing, storage, shipping and transfer of samples and data, as well as reporting/billing for study related operations
• Liaises with Precision Medicine Strategy Leads by assessing vendors, forecasting the biomarker sample operational costs, timelines and reviewing invoices to ensure we are aligned with budget plans

Data Acquisition and Management

• Works closely with data management lead to determine how biomarker data will be captured, blinded and transferred for clinical trials.
• Enables transfer of biomarker/exploratory data from vendor through development and review of an appropriate data transfer specification and related documents

Human Sample Management Flow and Compliance

• Provides guidance to clinical teams and clinical sites regarding collection and storage of biospecimen acquired in the course of clinical trials or other human sample acquisition projects
• Works with Precision Medicine Strategy Leads and clinical team to ensure sample collection and usage is in compliance
• Works closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed

Skills:

• Excellent written and verbal communication skills
• Analytical problem-solving experience
• Problem solving abilities, troubleshooting and resourcefulness
• Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and US FDA and/or local country regulations as applicable
• Effective communication and interpersonal skills
• The ability to build relationships internally and externally
• Familiarity with medical terms
• Demonstrates writing skills to deliver messages effectively so messages are clearly understood
• Proficiency in Microsoft Office applications

Knowledge and Experience:

6 - 8 years clinical research experience with academic, CRO or pharmaceutical/biotech industry. We are seeking a working knowledge of the clinical trials and clinical databases.

Education:

BS degree required – Major/ Minor (Biology or equivalent)

EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status