Clinical Laboratory Study Manager - FSP

Parexel; Honolulu (HI); On-site; USD 90,000 - 130,000; Full time

Job summary

Parexel in Honolulu seeks an experienced Clinical Operations professional to coordinate sample management and data flows across Precision Medicine Strategy, DM, SKDL and CLPM groups. Role ensures quality samples and data support biomarker evaluation and translation of science to medicine.

Requires 6–8 years clinical research, bachelor’s in life sciences, strong project management and communication, and ability to liaise with CROs and vendors to resolve sample-related queries.

Qualifications

• 6–8 years clinical research experience with academic, CRO or pharmaceutical/biotech industry.
• Working knowledge of clinical trials and clinical databases.
• Laboratory sample management experience is a plus.

Responsibilities

• Supports individual clinical study teams for technical and operational sample-related matters by liaising with internal stakeholders.
• Establishment, oversight, planning and integration of collection, processing, storage, shipping and transfer of samples and data, including reporting/billing.
• Liaises with Precision Medicine Strategy Leads and other scientists re vendors, forecasts sample operational costs, timelines and reviews invoices.
• Works with the data management lead to determine how sample and testing data will be captured, blinded and transferred for clinical trials.
• Provides guidance on collection, storage and shipping of samples, ensures protocol and ICF compliance, documents sample transfers.
• Keeps training, timesheets, expense reports, CV updates and maintains relationships across lines to support portfolio delivery.

Skills

Excellent communication

Project management

Independent work

Interpersonal skills

Microsoft Office

Education

Bachelor's degree in life science

Tools

Microsoft Office Suite

Job description

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.

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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.