Specimen Manager x1 - Cape Town at Synexa Life Sciences

JOB PURPOSE

• The specimen management unit is responsible for the day-to-day management of specimen shipments, specimen handling and specimen logging. Specimens are biological samples collected from either humans or animals and are a valuable resource. Specimens are essential to the biomarker and bioanalytical services conducted at Synexa and are vital to allow us to deliver for our customers.
• The unit is a key part in study delivery and supports Synexa delivery teams to achieve study milestones and accomplish deliverables, while delivering for our customers and supporting the teams to deliver revenue targets.

MAIN AREAS OF RESPONSIBILITY

General

• Provide administrative support as required by the laboratory.
• Perform designated duties in an efficient manner and completing tasks timeously.
• Where required, liaise with procurement and study management teams to arrange couriers for shipment of specimens or compounds/reagents and ensures these are in line with project budgets.

Specimen Management

Pre-Specimen Receipt

• Primary point of contact for external and internal communication related to specimens and Sponsor provided compounds/reagents.
• Confirm timelines for specimen shipments and ensures updated information is visible to the study delivery team via the Odoo planning app.
• Track incoming specimen and Sponsor provided compound/reagent shipments via courier on-line tracking systems and inform the study delivery team regarding any changes in expected timelines or any challenges/issues identified.
• Upon early receipt of shipping manifest for frozen specimens, log specimens and ensure source quality control checks are performed in the study specific sample log sheet, ensuring compliance with quality control method sheets.
• Highlight and resolve any queries related to specimen shipment manifests, requisition forms or equivalent documentation with the relevant CRO and/or Sponsor and ensure the communication is filed (hardcopy and/or electronic) for traceability.
• Ensure up to date sample log sheets are always available for study delivery team usage.

Specimen Receipt

• Ensure adherence to safety procedures upon handling of specimens.
• Receive specimens (as required per site), complete required paperwork and ensure sample log sheets are appropriately updated.
• Where required, file (hardcopy and/or electronic) temperature monitoring data provided by courier and share accordingly with CRO and/or Sponsor upon shipment receipt.
• As required, assist with labelling, sorting and storage of specimens and  Sponsor provided compounds/reagents.
• Upon receipt of fresh specimens, log specimens in a timely manner within study specific sample log sheets and conduct source quality control checks of paperwork ensuring compliance with relevant study documentation. This is time sensitive and critical to be prioritised to allow the study delivery team to perform required specimen testing.
• Review documentation received alongside specimen shipments and verify accuracy. Ensure the specimens meet GCP standards and document any integrity related issues.
• Escalate and resolve queries timeously and upon completion, file (hardcopy and/or electronic) paperwork appropriately.
• Communicate receipt of samples to relevant study delivery team members as well as externally to CRO and/or Sponsor.

Specimen Storage

• Ensure specimens are stored at the correct temperature and storage location is logged in the study specific sample log sheets.
• Alongside relevant laboratory personnel, manage storage location capacity.
• Maintain storage location upkeep by facilitating scheduled sample reconciliations.
• Upon completion of a project, enquire the fate of specimen(s) with the CRO and/or Sponsor and action decision accordingly.
• Based on laboratory requests, retrieve specimens for sample analysis from storage location and following testing, return and store appropriately and update relevant sample log sheets accordingly.

Specimen Administration

• Provide support to the delivery of the lab manual alongside the scientific team to outline specimen collection, processing, storage, and shipment instructions to ensure optimal specimen quality for required testing.
• Assess country specific import/export requirements for biological specimens or Sponsor provided compounds/reagents.
• Where applicable, together with site appointed biological safety officers, assess study specific GMO requirements and support with regulatory application and submissions.
• Where required, complete, submit and track permit applications to approval status from regulatory authorities ensuring no risks to overall study delivery.
• Manage and track permit validity and timeously submit re-applications to relevant authorities where required.

Phlebotomy/Specimen Collection

• Ensure local regulatory approvals are in place to allow donor sample collection to proceed.
• Ensure process specific documentation are completed as per local regulatory guidelines, approvals, and internal workflows.
• In response to laboratory requests, perform required tasks to arrange specimen collection from in-house donor(s) or external network.
• Per site requirement and capacity, manage consumables for specimen collection and as required, place orders via LIMS to replenish stock.
• Where qualified, support with blood draws and other sample collection techniques, following appropriate training and certification.
• Log billable units linked to specimen collection/phlebotomy in Odoo Projects.
• Highlight scope change needs to study management based on approaching out of scope specimen collection requests received from the lab.

EXPERIENCE & QUALIFICATIONS

• Bachelor’s degree or 2-3 years of experience in relevant field of work.
• Ability to oversee sample management activities across multiple studies
• Microsoft Office proficiency including Excel, Word, and Outlook.
• Demonstrated ability to collaborate with a diverse group of lab staff, clinical team members, vendor labs and stakeholders to support delivery milestones.
• ISO, GCP, GLP awareness. 
• Trained Phlebotomist.
• LIMS/LabKey software experience.
• Knowledge of clinical trials and understanding of the role of bioanalytical laboratory assessments in clinical studies.
• Working knowledge of clinical laboratory specimen management.
• Health and Safety knowledge

SKILLS AND COMPETENCIES REQUIRED

• Strong attention to details and quality.
• Excellent written, verbal, organizational and interpersonal communication skills to update stakeholders efficiently and succinctly in English.
• Prioritization skills.
• Ability to multitask.
• Good computer and IT skills.
• Professionalism.
• Eager to grow and develop capabilities.
• Problem solving skills.
• Good time management skills.
• Able to take initiative and work both independently and in a team.
• Administrative skills.
• Innovative.
• Works successfully under pressure.