Location: Philadelphia,PA, USA
Associate Clinical Sample Manager (Remote)
Philadelphia, PA
About the Position
The Associate Clinical Sample Manager will support the management and coordination of the day-to-day clinical sample activities for cell therapy trials. This role ensures the accurate tracking, handling, and documentation of clinical samples throughout the lifecycle of the study. The position requires close collaboration with clinical teams, external vendors, and laboratories to ensure samples are processed and analyzed according to study protocols and regulatory requirements.
Responsibilities Include
* Assist CSM to maintain logs to track the real time movement of samples from the clinical sites to the central laboratory or third-party labs
* Assist with clinical sample reconciliation of the central and local labs inventory with EDC as needed
* Work closely with IHCRA's to initiate kit shipments to the clinical sites for site startup and maintain up to date lab contact distribution lists
* Schedule shipments from central lab to third party lab to dispatch within stability window for critical clinical samples
* Review and approve shipping manifests as needed
* Execute virtual Central Lab SIVs trainings with clinical site's as needed and attend virtual site SIV's and present Central/Local Lab information where applicable
* Second reviewer for Sample Management generated documents and central lab generated documents and manuals
* File minutes and agendas from internal or external Sample Management related meetings and vendors
* File patient sample requisition forms (SRFs) along with associated data clarification forms (DCFs) in patient files
* Assist CSM in resolving central lab discrepancies in collaboration with clinical site coordinators via data clarifications forms as needed
Required Qualifications
* Bachelor's degree in Life Sciences, Biotechnology, or a related field. Advanced degree preferred.
* Minimum of 2 years of experience in clinical sample management, preferably in a cell therapy or biopharmaceutical setting.
* Strong understanding of GCP, GLP, and regulatory requirements for clinical sample handling.
* Proficiency with laboratory information management systems (LIMS) and other relevant software.
* Excellent organizational skills and attention to detail.
* Strong communication and interpersonal skills.
* Ability to work collaboratively in a team environment.
* Problem-solving skills and ability to manage multiple tasks simultaneously.
* Strong team orientation and passion for continuous self-development.
* Experience in the biotech industry or in a startup industrial setting is preferred.
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