Laboratory Operations Manager

Clinlab Solutions Group; Maryland; On-site; USD 90,000 - 120,000; Full time

Job summary

Clinlab Solutions Group in Montgomery County, Maryland seeks a senior operations professional to oversee translational medicine laboratory activities, including sample management, vendor relations, and regulatory compliance. You will ensure efficient workflows, adherence to protocols, and support for clinical research studies.

Responsibilities include managing sample handling, outbound shipping, vendor coordination, SOP development, and collaboration with cross-functional teams to maintain chain

Qualifications

• Bachelor’s degree in healthcare, life sciences, or a related discipline.
• Minimum of five years of professional experience in sample management, equipment management, or sample analysis.
• Experience in a regulated clinical or biological laboratory.
• Background in clinical study sample coordination for early and late phase clinical trials.
• Experience working in a GxP environment with knowledge of regulatory compliance requirements.
• Excellent verbal and written communication skills.
• Working knowledge of GxP regulations and LIMS-based systems.
• Vendor management experience and experience writing/maintaining SOPs.
• Understanding of clinical biospecimen chain-of-custody from collection through long-term retention.

Responsibilities

• Manage all aspects of sample handling, including receiving, accessioning, discrepancy resolution, data reconciliation, and disposition for translational medicine studies.
• Coordinate outbound sample shipping and maintain accurate documentation for all sample transfers.
• Facilitate shipment of research samples between laboratories and third-party vendors, ensuring proper chain of custody.
• Collaborate with clinical operations, laboratory staff, and external partners on specimen management and study support activities.
• Oversee vendor activities related to translational research assays, including contract compliance, timeline alignment, and serving as the primary vendor contact.
• Support data review, transfer, archiving, and issue resolution in partnership with data management and laboratory teams.
• Develop and maintain processes and SOPs to ensure regulatory compliance and proper sample chain of custody.
• Participate in clinical study closeout activities, adhere to safety and compliance requirements, and perform additional duties as needed.

Skills

Sample management

Vendor management

Regulatory compliance

Communication

Data reconciliation

Education

Bachelor’s degree in healthcare, life sciences, or related

Tools

LIMS

Job description

Work Location:

Montgomery County, Maryland

Summary:

Oversee and coordinate all aspects of translational medicine laboratory operations, including sample management, vendor relations, and compliance with regulatory standards. Ensure efficient workflow and adherence to protocols for clinical research studies.

Responsibilities:

• Manage all aspects of sample handling, including receiving, accessioning, discrepancy resolution, data reconciliation, and disposition for translational medicine studies.


• Coordinate outbound sample shipping and maintain accurate documentation for all sample transfers.


• Facilitate shipment of research samples between laboratories and third-party vendors, ensuring proper chain of custody.


• Collaborate with clinical operations, laboratory staff, and external partners on specimen management and study support activities.


• Oversee vendor activities related to translational research assays, including contract compliance, timeline alignment, and serving as the primary vendor contact.


• Support data review, transfer, archiving, and issue resolution in partnership with data management and laboratory teams.


• Develop and maintain processes and SOPs to ensure regulatory compliance and proper sample chain of custody.


• Participate in clinical study closeout activities, adhere to safety and compliance requirements, and perform additional duties as needed.

Qualifications:

• Bachelor’s degree in healthcare, life sciences, or a related discipline.


• Minimum of five years of professional experience in sample management, equipment management, or sample analysis.


• Experience in a regulated clinical or biological laboratory strongly preferred.


• Background in clinical study sample coordination for early and late phase clinical trials.


• Experience working in a GxP environment with knowledge of regulatory compliance requirements.


• Excellent verbal and written communication skills.


• Working knowledge of GxP regulations and LIMS-based systems.


• Vendor management experience and experience writing/maintaining SOPs.


• Understanding of clinical biospecimen chain-of-custody from collection through long-term retention.


• Ability to multitask, prioritize in a fast-paced environment, and meet deadlines.


• Strong organizational skills and proven ability to work independently.


• Experience working in a matrix environment.