Biospecimen Project Manager

This is a fully remote position, open to applicants in Massachusetts, +1 more state.

📋 Description

• Act as the primary point of contact for the management of biospecimen lifecycles and associated analytical data from clinical trials.

• Oversee the entire biospecimen lifecycle from sample reception through analysis to final disposition.

• Ensure the accuracy of specimen metadata.

• Relay updates regarding study specimens to client groups and stakeholders.

• Enhance the efficiency of specimen management by disseminating knowledge and best practices.

• Provide support to sites and facilitate the resolution of queries.

• Engage in or lead special projects as needed.

• Comply with client policies and adhere to Standard Operating Procedures (SOPs).

• Evaluate clinical study protocols and the scope of work documents from service providers for details on sample handling and processing.

• Establish and maintain intricate study sample trackers.

• Develop and oversee project plans.

• Coordinate data transfer plans with analytical laboratories.

• Manage data received from both external and internal laboratories, including exploratory studies.

• Address and resolve discrepancies in specimen metadata.

• Submit specimens for analytical assays in accordance with study timelines.

• Assess the status of specimen receipts and ensure data completeness.

• Assist in database locks by confirming that all specimens have final results and that data transfers are complete.

• Generate reports for data management as required.

• Aid in annual and long-term planning projections.

• Offer support and serve as a technical resource within the department.

⛳️ Requirements

• Bachelor’s degree in life sciences, medical technology, or a related field is required.

• 3 to 5 years of experience in managing biospecimen samples from receipt through analysis to final disposition is required.

• Familiarity with transaction-based inventory and data management systems, as well as clinical trial processes.

• Knowledge of ICH, GCP, GLP, and local regulations is essential.

• Project management experience is highly preferred.

• Strong communication skills are a must.

• Excellent planning, organizational, and time management abilities.

• Exceptional attention to detail and proficient multi-tasking skills.

• Proficient in Microsoft Office applications, including Excel, with knowledge of macro and template creation.

• Experience with Laboratory Information Management Systems (LIMS) is advantageous.

🏝️ Benefits

• Fully remote work arrangement.

• Opportunity to work standard East Coast business hours.

• Potential travel 2 to 4 times per year to Cambridge, MA.