Position - Temp - Clinical Laboratory Study Manager
Pay Range - $65.76 - $84.43/hr
Location - Remote (US)
Duration - 9 Months

Individual will work with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical Laboratory Project Management (CLPM) groups to ensure quality samples and data are delivered to support biomarker and non-biomarker evaluation and enable the translation of science to medicine. Responsibilities include oversight of clinical sample collection, usage per informed consent form, sample tracking (chain of custody), management of central laboratory and specialty vendors and sample destruction.

A typical day might include the following:

• Participates in cross-functional study teams and sub-teams across clinical and research departments

• Monitors acquisition of clinical trial samples (including human tissue, whole blood, plasma, serum, etc.) and testing at central/specialty lab with support from SKDL

• Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders, such as working with ICF specialist in SKDL on ICF and other trial documents impacting samples and testing

• Establishment, oversight, planning, and integration of all issues related to collection, processing, storage, shipping and transfer of samples and data, as well as reporting/billing for study related operations

• Liaises with Precision Medicine Strategy Leads and other scientists by assessing vendors, forecasting sample operational costs, timelines and reviewing invoices to ensure we are aligned with budget plans

• Works closely with data management lead to determine how sample and testing data will be captured, blinded and transferred for clinical trials.

• Provides guidance to clinical teams and clinical sites regarding collection, storage, and shipping of samples acquired in the course of clinical trials or other human sample acquisition projects

• Works with scientists and clinical team to ensure sample collection and usage is in compliance with study protocol and applicable ICF

This role may be for you if:

• You have excellent written and verbal communication skills

• You can handle and resolve problems spontaneously and possess strong project management and organizational skills

•  You can work independently and proactively while still contributing to group initiatives and goals

• You have strong interpersonal skills and ability to work with many different groups/teams to achieve success

• Hands-on experience with database lock procedures in Phase I-IV clinical trials

To be considered for this role, you must have a B.S degree – Major/ Minor (Biology or equivalent) with 6 - 8 years clinical research experience with academic, CRO or pharmaceutical/biotech industry. We are seeking a professional with working knowledge of clinical trials and clinical databases.

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third-party solicitation