Clinical Laboratory Study Manager - FSP

Parexel • Nashville, TN • 9h ago

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. 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.

Operations Management

Study Team Support

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 Informed Consent Form (ICF) specialist in SKDL on ICF and other trial documents impacting samples and testing

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 alignment with budget plans

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

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

Compliance with Parexel Standards

Complies with required training curriculum

Completes timesheets accurately as required

Submits expense reports as required

Updates CV as required

Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitate effective portfolio delivery

Skills:

Excellent written and verbal communication skills

Resolve problems spontaneously and possess strong project management and organizational skills

Work independently and proactively while still contributing to group initiatives and goals

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

Microsoft applications

Knowledge and Experience :

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. Laboratory sample management experience is a plus.

Education:

Bachelor's degree in a life science, nursing qualification or other relevant experience required.

LI-LO1

LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Parexel

Go to Apply

Share this job

Similar Jobs

Licensed Practical Nurse - Spine Clinic - 100 Oaks

Vanderbilt University Medical Center • Nashville, TN • 2h ago

Hospital & Medical

Discover Vanderbilt University Medical Center : Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day...

2h ago

Go to Apply

Sonographer | Outpatient | Float

Vanderbilt University Medical Center • Nashville, TN • 2h ago

Hospital & Medical

2h ago

Go to Apply

RN Case Manager, FT Days - Monroe Carell Jr. Children's Hospital at Vanderbilt

Vanderbilt University Medical Center • Nashville, TN • 2h ago

Hospital & Medical

2h ago

Go to Apply

Medical Assistant PRN - Urology Clinic

Vanderbilt University Medical Center • Nashville, TN • 2h ago

Hospital & Medical

2h ago

Go to Apply

RN Case Manager - Home Health

Maxim Healthcare • Brentwood, TN • 2h ago

Hospital & Medical

RN Case Manager - Home Health Location: Nashville, TN Salary Range: $73,000 - $79,000 + $5,000 Annual Bonus Potential (paid quarterly) Ready to Elevate Your Nursing Career Beyond the Bedside? Maxim Healthcare is seeking...

2h ago

Go to Apply

Weekend Licensed Respiratory Therapist

Trevecca Center for Rehabilitation and Healing • Nashville, TN • 6h ago

Hospital & Medical

Schedule This will be your standing schedule. We are looking for a RT that can work the following schedule below consistently. 4- 6 hours per shift ; maybe up to 8 hours depending on caseload Saturday and Sunday Respirat...

6h ago

Go to Apply

Scientist III - Analytical Chemist (Drug Product) - FSP

Parexel • Nashville, TN • 8h ago

Hospital & Medical

We are looking to fill a Scientist III - Analytical Chemist (Drug Product) support position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ . This...

8h ago

Go to Apply