Overview
LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.
We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.
Summary
The Clinical Biomarker Operations Lead will be the centralized point of contact to implement and communicate project needs, processes, and practices for all assigned studies and projects. Will work cross-functionally to support multiple stakeholders including labs, therapeutics units, Clinical Operations, Procurement, R&D, IT, and Quality. Will be responsible for leading project management efforts and providing subject matter expertise to support clinical biomarker operations and logistics with external venders, thereby helping generate high-quality translational biomarker data.
Responsibilities:
- Independently develop and manage strong relationships with external CRO biomarker testing labs and bioassay vendors.
- Manage and lead complex projects and programs, including supervising and mentoring other project managers, coordinators, or scientists.
- Provide all project management for biospecimen and biomarker activities including biomarker specimen management and tracking, ensuring timely sample testing, data reconciliation, and management.
- Serve as the primary point of contact between internal stakeholders and external laboratories, with oversight responsibilities for the development and finalization of agreements, statements of work, sample analyses, data transfer specifications, and data transfer agreements.
- Qualify and onboard new vendors as needed, including facilitating the execution of CDAs/MSAs and submission (and follow through) of audit requests.
- Coordinate and deliver the biomarker specimen strategy within multiple clinical programs with the requirements of quality and ethical and regulatory standards, including ICH/GDPR/GCP/GLP.
- Collaborate with study teams and Clinical Biomarker and Global Translational leads to develop and implement Clinical Sample Management Plans.
- May lead and manage supplier/vendor performance and relationships with attention toward opportunities to reduce costs, alleviate risks and drive continuous improvement.
- May assist with reviewing and writing SOPs, clinical study protocols, informed consents, central laboratory documents, or working instructions for projects, groups, or laboratories, ensuring quality and accuracy.
- Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker specimens (oversight of sample collection at site, shipment to vendor for testing/processing, analysis, reconciliation, and final sample disposition).
- Utilize and optimize tracking systems (such as Labmatrix) to report progress, address issues, and resolve problems in timely manner.
- Interface with data standards and data management teams to ensure biomarker data standards are defined for each readout in data transfer specifications (DTS) and that approved controlled terminology is used within clinical study protocols.
- Oversee finalizations of data transfer agreements and ensure that data is transferred between bioassay vendors and CROs to meet clinical trial and translational requirements and timelines.
- Participate in and/or lead process improvement projects under direction of manager.
Education/Experience/Skills Required:
- BA/BS in life sciences, medical technology or related field; advanced degree preferred;
- 5-7+ years of experience in life sciences or medically related field, including clinical development, biospecimen lifecycle management or clinical laboratory analysis.
- Previous experience with clinical biomarker management, required
- Scientific knowledge with strong operational skills.
- Experience in team management and leadership.
- Demonstrated project management experience and skills including timeline management, forecasting, and project management tracking (project management software a plus).
- Effective oral and written communication skills, experienced with technical writing.
- Strong computer literacy, including word processing, Smartsheet, SharePoint, PowerPoint and spreadsheet applications.
- Ability to work effectively in a matrix environment.
- Ability to build and maintain strong relationships with external vendors, partners, collaborators, and stakeholders.
- Understanding of clinical research and the clinical trial process.
- Advanced planning, organizational, and time management skills.
- Ability to work independently, prioritize tasks, and mentor/lead others.
- Working knowledge of ICH, GCP, GLP and local regulations. Advanced planning, organizational, time management skills required.
- Working knowledge of Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and/or Clinical Laboratory Improvement Amendments (CLIA)
Work Location/Hours/Travel:
- Position is 100% remote, with strong preference to be located in California (San Rafael/Bay Area preferred)
- Ability to be onsite with client at least 6 times per year
- Ability to work West Coast core business hours, Monday - Friday
Read more below and get ready for your next great employment adventure!
Some of the Perks our LabConnectors Love:
- Financial Security (base pay, 401k match and annual bonus eligibility)
- Health Benefits beginning on date of hire
- PTO plan plus 10 Paid Company Holidays and 1 day to Volunteer in your community
- Short and Long-Term Disability, Life and AD&D
- We celebrate our differences, which enrich our Culture
We are a growing and global team on a mission to create healthier communities by accelerating the development of new medicines. In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities.
We believe in a friendly and collaborative environment with open lines of communication. Join our team and discover how your work can impact the lives of people all over the world.
It is the policy of LabConnect to provide equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law.
Equal Employment Opportunity Posters:
https://www.dol.gov/agencies/ofccp/posters
If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please email talent@labconnect.com or call +1(423)722-3155.
For more information, visit www.labconnect.com
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