Functional Assessment Associate
Functional Assessment Associate
Job Number: 20-07873
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Functional Assessment Associate 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!
- Work closely with our Translational Medicine teams to evaluate and on-board new biomarker analytical labs.
- Operational prowess with respect to biomarker analyzing labs will be a key part of this position.
- The ability to assess a labs competency in providing new biomarker tests and run new assays will be integral to the position and as such interfacing with Client subject matter experts to assist in the assessment is key to the role.
- Interfacing with all Client teams, audit, quality, IT and others will offer the opportunity to engage in a broad array of Client departments and personnel.
- The successful candidate will be responsible for ensuring timely delivery of due diligence efforts on behalf of all technology areas, including but not limited to, Genetics and Genomics, Immunoassays and Mass Spec, Flow Cytometry, Immunohistochemistry and Pathology, and Companion Diagnostics.
- Will include end-to-end involvement from provider identification through provider approval from an operational aspect.
- A lab quality background including exposure to laboratory certification requirements, and some experience working in or directly with analyzing labs is highly desirable.
- This is a highly matrixed position and relies on strong organizational expertise and robust soft skills.
- This position will require the ability to work remotely/independently at the current time but may change to an onsite position at a later time with growth opportunities.
- Primary Role:
- Support and drive the due diligence/functional assessment process with multiple stakeholders from diverse technologies.
- Work closely with Alliance Leads and Technical Leads to support vendor relationships and partnership growth.
- Coordinate internal resources and third parties/vendors for required due diligence efforts commensurate with data use.
- Establish relationships both internally and externally with stakeholders interested in on-boarding new analyzing labs.
- Coordinate subject matter expert input and review of due diligence questionnaires. Ensure electronic filing of all documentation.
- Ensure coordination of diverse team members input on both internal and external facing documents.
- Ensure proper documentation of meetings.
- Update and document the status of the due diligence process and notify stakeholders of progress.
- Collate information into a final due diligence/functional assessment report, ensuring internal coordination among interested stakeholders and coordination with Global Procurement for remediation efforts and negotiations.
- Bachelor’s degree and 3-5 years’ experience in clinical drug development/scientific discipline, quality
- Master’s degree and 2+ years’ experience.
- Experience interacting with analyzing or reference labs.
- First-hand knowledge of laboratory operations and/or direct laboratory experience.
- Demonstrated strong project management skills and ability to drive multiple projects in a highly virtualized team environment.
- Exposure to CLIA/CAP regulations and regulatory guidelines/submissions a plus.
- Ability to influence in the matrix and across organizational/company boundaries.
- Ability to quickly learn and leverage in house IT technology solutions for information management.
- Highly effective organizational and time management skills.
- Demonstrates strong communication (written and oral), interpersonal skills.
- Fosters teamwork between Client functional areas; creating a team environment based on mutual trust and respect.
- Encourages teams to share knowledge, experiences, best practices, and information on an ongoing basis.
- Embraces a culture of diversity and inclusion to enhance personal and company performance.
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:
Maria Castañeda | 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.