Customer Service Representative - ClinLab Staffing : Job Details

Clinical Supply Associate – Philadelphia, PA

The Clinical Supply Associate is responsible for ensuring the continuous supply of radiopharmaceutical clinical trial material from global contract manufacturing organizations (CMOs) to imaging sites while meeting customer expectations. This includes but is not limited to, maintaining the dose ordering management system and working closely with internal and external manufacturing teams to ensure a reliable supply of radiotracers.

• Responsibilities:Manage information within the dose ordering management system: Including manufacturing site information, production schedules, clinical trial protocol details, imaging site information, RAM license, logistics, and managing dose requests.
• Liaison with Clinical Trial Operations and CMC to ensure reliable supply of radiotracers:
• Review information about manufacturing site locations, country specific license requirements, imaging site logistics, and protocol specific limitations during protocol establishment and approval.
• Triage production schedule changes with CMC and Clinical Operations to minimize impact to study coordinators, imaging sites, and patients.

Monitor day of production (batch release status), send release paperwork to imaging sites as appropriate, and triage dose delays or cancelations.

Investigate and document clinical supply complaints and communicate issues to the proper departments in a timely manner.

Write and revise clinical supply guidance documents to clearly communicate capabilities and restrictions of CMOs with respect to clinical trial supply

Write and revise departmental SOPs in support of clinical supply activities

Other duties as assigned

Qualifications:

• Preferred bachelor's degree in a scientific or statistics field, if not then high school degree required
• Preferred 1-3 years' experience in supply chain logistics
• Fully versed in Office 365 suite
• Understanding of SQL Database backend structure and end user interfaces