Biospecimen Project Manager

Job Summary

The Biospecimen Project Manager will be the centralized point of contact developing and establishing processes to drive biospecimen lifecycle management in support of Translational Sciences and Clinical Trials teams.

Please note: This is a 6-month position, with the potential for extension based on business needs and performance.

Essential Duties and Responsibilities

Develop and lead processes that support specimen lifecycle management from sample receipt to analysis and final disposition or long-term storage

Monitor specimens with attention to tracking location, viability, alignment with retention requirements

Evaluate, develop and effectively document and communicate process

Ensure accurate specimen metadata

Communicate study specimen updates to client groups and stakeholders

Increase the efficiency of specimen management through sharing of knowledge and best practices

Establish processes and systems to simplify transfer processes between vendors, ensuring accuracy in data recorded at study or project initiation and mechanisms to track specimen status and location throughout the duration of its lifecycle

Provide site support and drive query resolution

Manage specimen metadata discrepancies and ensure resolution

Manage data transfer plans with analytical laboratories and resultant data

Participate in or independently lead special projects as assigned

Adhere to client policies and Standard Operating Procedures

Review clinical study protocols and service providers’ scope of work documents for sample handling and processing details

Set up and maintain a complex study sample tracker, dashboards and tracking tools

Attend meetings or calls with Translational Sciences or Clinical Trial Management teams, vendors, partners and study stakeholders

Create and manage project plans, templates and framework for consistent execution across vendors and projects

Establish a centralized repository in a preferred vendor management system for MSAs, work orders, sample forms, validation or qualification results, and internal registry of assays or biomarkers for future use

Support study setup through the creation and implementation of intake forms consistently leveraged across vendors and sites supporting studies

Review and provide oversight of sample storage and retention policies, establishing framework for consistent tracking across projects and vendors

Review status of specimens received and completeness of data

Ensure that specimens are submitted and resulted for analytical assays per required timelines

Investigate and resolve complex queries

Ensure transfer is complete; create reports for data management as needed

Support annual and long-term planning by monitoring and providing projections for milestones, specimen storage or analytical needs, and budget

Management of archival study documentation

Education and Experience

B.A./B.S. in life sciences, medical technology, or related field and a minimum of 2-3 years of directly related experience

Experience in biospecimen lifecycle management required, with experience in life sciences or medically related fields such as clinical development or clinical laboratory analysis

Strong Project Management experience, with demonstrated organizational skills required

Vendor Management (bioanalytical and specialty laboratories) with outsourcing experience preferred

Budgeting and forecasting experience preferred

Skills and Ability

Very high attention to detail and excellent multi-tasking skills are required for success in this position

Demonstrated ability to establish and qualify processes, assessing risk and identifying mitigation strategies or creating streamline efficiencies where possible

Understanding of transaction-based inventory and data management systems as well as clinical trial processes

Understanding of ICH, GCP, GLP, and local regulations required

Ability to draft SOPs, work instructions, templates required

Excel experience, macro and template building knowledge

Experience within sample tracking platforms, LIMS systems, SharePoint required

Experience with Clinical Maestro preferred

Strong planning, organizational, time management skills

Ability to lead projects within a cross-functional matrix