IP Specialist (Senior CTA) – Flexible UK location – Client Dedicated
This unusual role is a client-dedicated position with a global pharma company and would suit someone who has worked in IP Management, perhaps at a large CRO / Pharm company or a Clinical Supplies organisation. To apply you must be based in the UK and comfortable working full time and on a permanent basis.
The key duties of this role include:
- To control IMP stock, dispatch and reconciliation for clinical trials conducted by CSU.
- Assist the Cluster IP Manager in the management of the in-house distribution centre or local sub-contractor for IMP services
- To effectively track expenses accrued in IMP management to enable invoices to be validated before approval.
- To track supplies stored with sub-contractor (e.g. test strips, needles) and manage effectively for best business value.
- To ensure timely and effective communications are maintained at all times with CSU study team members about issues pertaining to the IMP for their study
- To ensure all IMP is supplied, handled, and destroyed in complete compliance with UK/ROI regulations, GCP guidelines and company Corporate and Local SOPs.
- Act as the main local contact for all issues pertaining to IMP management for the UK CSU with both internal and external customers.
- To ensure complete traceability and accountability for all IMP used by CSU in the conduct of clinical trials.
- Ensure at all times that a full trail of IMP documentation is present in the Local Study File (LSF) for audit and regulatory inspections.
- Screen all IMP related documents, provided by the Monitoring Team (MT) or through other sources, applicable to the management of IMP for accuracy and completeness and file in the LSF for audit and regulatory inspections.
- Assist the Cluster IP Manager in the review and approval of the IMP labelling by the CSU Clinical Trial Regulatory Manager (CTA-RM) for any assigned clinical studies in accordance with the applicable regulations.
- Advise the Cluster IP Manager (in liaison with the CPL and CTA-RM)) that appropriate essential documents are in place to allow submission of the IPSO1 to Corporate to request IMP is imported to the UK.
- Manage the process of authorisation for the distribution of IMP supplies utilising the necessary documentation from SOPs, investigational centres and the local sub-contractor managing the supplies.
- Prepare and maintain a tracking tool to record the regulatory information required by the applicable laws for IMP: this will include essential information such as records of shipment, receipt, disposition, return and destruction including details of expiry dates, batch numbers and drug reconciliation.
- Assist the Cluster IP Manager in the effective management of sub-contractors contracted to manage IMP.
- Co-ordinate and be the main local contact for the process of IMP deviations (e.g. temperature excursions) until resolution
- Co-ordinate and be the main local contact for the process of IMP complaints until resolution.
- Upon the instructions of the Cluster IP Manager, co-ordinate and be the main local contact for any IMP re-labelling processes.
- Upon the instructions of the Cluster IP Manager, co-ordinate and be the main local contact for a product recall process
- Ensure code breaks are effectively managed and tracked.
- In association with the Cluster IP Manager and Cluster CQPTA (Clinical Quality, Process & Training Ambassador) ensure appropriate local procedures are written and remain current.
- Assist the Cluster IP Manager and Cluster CQPTA for training of CSU staff in local IMP management procedures.
Other Information: This role is a full time & permanent position to be employed through Covance. For more information please contact Andy Smith at Covance on 07775 848 250 or mail firstname.lastname@example.orgEducation/Qualifications:
- Educated to degree level
- Experience in IP distribution /clinical research
- Previous experience in clinical research or logistic
- Knowledge of the statutory requirements of IPM management in the UK and ROI as defined by the EU Commission Directive 2030/94/EC, EU Commission, GMP, Annex 13, EU Clinical Trial Directive, UK legislation, ROI legislation, and ethical guidelines.
- Knowledge of and experience with GCP and other regulations in force; ability to learn and apply SOPs and quality control.
- Excellent interpersonal, communication and organisational skills.
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