Temp Clinical Laboratory Study Manager

Pay Range: $90.00 - $110.00/hr

Remote Role

12 Month Contract

Regeneron's Precision Medicine Group is looking for a Temp - Clinical Laboratory Study Manager (CLSM) to join our team!

In this role, a typical day might include:

Works 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.

Individual will work closely with internal and external groups/vendors to manage and support the generation of quality laboratory data. Will work closely with project managers (central and/or specialty labs) and lend expertise to clinical trial management (CTM) and CRO to ensure samples are collected per protocol and assist with resolving any sample related issues or queries. Additional responsibilities include overall project management in alignment with the core business strategy.

Study Team Support

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

Supports and manages activities leading to database lock, including timelines, status reports, issue tracking, reconciliation tracking and query resolutions

Use Excel and other tools to track metrics, create visualizations, and generate ad hoc reports

Collaborate with Clinical Data Management, Clinical Operations and CROs to support database lock activities

Operational Support of Sample Analysis (including exploratory analysis)

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

Provides input on sample-related section in clinical trial-related (e.g. protocols and ICF) and other supporting documents

Prepares RFPs, reviews and assess bids and SOWs for items related to samples and testing

Participates in oversight activities with vendors and other collaborators, and supports audits as required

Oversees study start up, closeout and overall life-cycle activities for assigned studies at central lab/specialty labs to support all samples and testing

Provides guidance and trainings to vendors, collaborators and clinical sites on sample collection, processing, shipping, and storage

Data Acquisition and Management

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

Enables transfer of sample/testing data from vendor through development and review of an appropriate data transfer specification and related documents in collaboration with SKDL

Human Sample Management Flow and Compliance

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

Works closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed

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 opportunity, you must have the following:

To be considered for this role, you must have a B.S degree – Major/ Minor (Biology or equivalent).

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