Usa-Project Manager II (Clinical)

Immediate need for a talented Outsourcing Manager/BioMarker Manager. This is a 12+ Months contract opportunity with long-term potential and is located in Bridgewater, NJ (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 24-28429

Pay Range: $65 - $75/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Requirements and Technology Experience:

• Act as the project manager to support the externalization and operationalization of clinical biomarkers and bioanalytical activities for pre-clinical and clinical drug development.

• Support the team on budget predictions, management and tracking for a clear understanding of the biomarker operations and their impact on the project.

• Be the key point of contact for biomarker activities whether they are managed externally or internally to inform the team to make data driven decisions.

• Oversee PK or ADA bioanalysis that is performed externally.

• Identify and help onboard vendors for specific analysis, provide advice and support on scientific and technical aspects of analysis where possible.

• Interact closely with Translational Medicine (TM) subteams to execute biomarker plans for clinical studies.

• Monitor assay development, assay validation and sample analysis processes, ensure timely delivery of quality results in compliance with regulatory guidance.

• Support final data import.

• Interface with Central Labs and sample management team to ensure the sample logistics meet study requirements.

• Work collaboratively with the CROs, ensure that all studies are managed in respect to timelines, budget, scientific integrity, and quality deliverables.

• Assure all aspects necessary for contracting studies are in place. This includes developing and maintaining a strong working relationship with Procurement, Legal and other support functions to provide RFP (Requests for proposal/information), Legal Contracts, etc..

• Collaborate with Quality Assurance to establish and perform audits and ensure that selected CROs respect the quality assumed by

Our client is a leading Healthcare organization and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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