Biosample Operations Manager

Description

• Manages and coordinates study set up in Sample Management system
• Acts as liaison between study team, Sample Management vendor and Biosample vendors
• Monitors study build and rollout according to timelines.
• Ensures system training is conducted and support study team usage.
• Contributes to ongoing team forum by providing feedback on lessons learned, discuss challenges and changes etc.
• Collects and maintains completed lessons learned and evaluation documents for consolidated review

Process Development, Improvement And Maintenance

• Supports the maintenance of any associated quality documents relative to Biosample management to ensure they are kept current and accurate.
• Supports the maintenance of the Biosample Operations Work Instructions and Templates.
• Participates in vendor evaluation as required (e.g., new technologies, clinical CRO selection).
• May contribute to various Medical & Development process improvement initiatives and SOP (or other quality document) development.

Training And Communication

• Identifies any training needs and participates in the development of any sustainable training materials required.
• Supports the ongoing review of training materials to ensure they are current, accurately reflect the appropriate BSMO processes and are appropriately deployed to the affected departments and job functions.
• Maintains the BSMO SharePoint site.

Qualifications

• Bachelor's degree (or equivalent) with scientific or clinical background, study management experience preferred
• 2 plus years related experience in pharmaceutical, clinical research or health services industry with a minimum of 1 years’ experience as clinical study manager, central laboratory project manager, data manager, or project manager.
• Working knowledge of GCP, FDA and/or EU Clinical Trials Directive guidance documents
• Experience with protocol and clinical drug development processes
• Proven project management skills and leadership ability
• Excellent interpersonal, written, and verbal communication skills and computer ability