Biomarker Operations Specialist
Biomarker Operations Specialist
Job Number: 20-01367
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Biomarker Operations Specialist for our client in Lawrenceville, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- As a core member of Biomarker Operations Team, you will be responsible for developing and documenting the Biomarker Testing Plan (BTP) for 15-25 I-O protocols, ensuring implementation of the BTP, and driving time lines for generation and return of data.
- Within this highly matrix organization, you will engage internally with medical, clinical, technical and operational leaders to ensure alignment and feasibility and externally with central labs and analyzing labs to ensure success for any outsourced elements of the biomarker strategy.
- Collaborate closely with biomarker scientists to document the program/protocol BTP plan and provide guidance for operationalization
- Drive assets within your Book of Work, ensuring that all required testing is well defined and documented within supporting systems to facilitate the effective application of Biomarker strategy to our development portfolio
- Develop and manage project plans for data delivery to ensure timeliness of data for exploratory analyses and clinical results; from specimen selection, routing, testing, return of data, and analysis of results
- Initiate contracting for biomarker work, ensuring alignment between internal technology leads and vendors, review SOW, identify and request samples shipments
- Ensure that sample collections, movement, analysis and data sharing are in accordance with protocol and informed consent
- Track, resolve and appropriately escalate issues related to sample and/or data quality (overseeing consistency, integrity, and completeness of biomarker data generation following review of results)
- Engage effectively with central labs, external vendors and internal labs to ensure timely and consistent execution of biomarker processing, analysis and data delivery
- Manage results provided by third-party vendors (e.g., defines data handling conventions, edit checks, quality acceptance; reconciles external data against the clinical data; resolves data discrepancies between the external data and the clinical data)
- Foster teamwork between functional areas; creating a team environment based on mutual trust and respect. Encourage teams to share knowledge, experiences, best practices, and information on an ongoing basis
- Bachelor’s degree and 7+ years’ experience in clinical drug development/clinical trial execution, or Master’s degree and 2 +years’ experience
- Demonstrates in-depth knowledge of biomarkers, Pharmacokinetics or immunogenicity sample activities, including collections and logistics considerations. Thorough understanding of clinical data management
- Experience managing multiple projects of significant complexity/global scope, in a highly virtualized team environment
- Strong communication, interpersonal and negotiating skills--leveraging those competencies to ensure continuous progress internal and external teams thus moving issues to resolution
- Highly effective organizational and time management skills
- Demonstrated ability to analyze and interpret complex problems/data from a variety of sources, and through effective decision-making and planning, deliver superior business results
- Experience with bioinformatics and analytical software tools (i.e. JMP, Spotfire)
- Experience and high degree of fluency with MS Office tools (esp. MS Excel and MS Project)
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Antonette Dizon | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.