Precision Medicine Operations Lead

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 sites, and project managers

central and / or specialty labs) 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.

JOB RESPONSIBILITIES

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

JOB REQUIREMENTS

This role may be for you if :

• Excellent written and verbal communication skills
• Ability to handle and resolve problems on the fly as well as strong

project management and organizational skills

Ability to work independently and proactively while still contributing to group

initiatives and goals

Strong interpersonal skills and ability to work with many different groups / teams to

achieve success

EDUCATION

To be considered for this role, you must have a B.S degree - Major / Minor

Biology or equivalent).

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.

LI-REMOTE