Ref #: 27593

Employment type: Permanent - Full-Time

Location: England and Wales

Posted: 27-Apr-2021

Description

Key Responsibilities:
* Services include project management and serving as the primary point of contact between the sponsor and packaging and labelling vendors from the point where orders are requested to kit shipments to depots. Services/deliverables include ensuring vendor oversight, obtaining quotes, timelines and negotiation deliverables with the vendor. Lead the operations meetings, work closely with the CSC teams, obtains components, ensures labels are designed, created and printed by label vendors, reviews and approves quotes and invoices, responsible for supporting
audits performed by agencies and provide business support for vendor audits, and creation of sop’s. Further, services/deliverables include partnering with Supply Chain Coordination for incoming drug product, and ID sample shipments
* Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory
requirements, ICH-GCP, etc
* Creates and maintains the individual project agreements (IPA) between CSC and P&L vendors
* Obtains, reviews, and approves quotes and invoices
* Lead the operational meeting per compound ensuing all deliverables are communicated
* Negotiates timelines and oversees the project progress to ensure timely release and distribution of the clinical material to depots
* Collaborates within the CSC and influencing stakeholders to improve services, cost or lead time
* Responsible for the creation, design, and printing of different label types
* Collaborate with MST to ensure equipment, pack types and labels meet the requirements of the team
* Review and approve relevant parts of source documentation (IMPA, IPA SLED)
* Supports the release of clinical trial material
* Oversees P & L budget, inventory oversight, and destruction of expired materials
* Conduct issue resolution activities for supply aspects of clinical studies
* Develop strong internal collaboration within CSC and with the vendors to ensure customer satisfaction
* Develop excellent working relationships with the other groups within Supply Management
* Manages the outsourced packaging and labelling activities required to meet First-Patient-In date of clinical trials
* Ensures tracking of project timelines updated in a timely manner
* Primary contact for assigned orders, engaging with PM’s, quality, and other staff throughout the life of the trial (documentation, meetings, quality communication, etc.)
* Manage events, deviations and CAPAs and implement process improvements (route cause analysis, corrective and preventive actions, impact assessment, organize training, update SOPs)
* Manages all aspects of issue escalation and resolution at the vendor site and internally with ESIQ or QA
* Escalates any timeline or process issues


Required experience and qualifications:

* Academic degree, plus 6+ years total experience, and 4+ years of experience in a clinical supply related role
* General knowledge of GxP principles
* Experience with the following functions preferred:
o clinical supply pack/label/distribution
o clinical trial operations, project management
o research and development
o inventory management
* Ability to work independently with limited coaching
#clinicalcoordinatorjobs