Ref #: 30898

Employment type: Permanent - Full-Time

Location: United Kingdom

Posted: 14-Sep-2021

Description

RESPONSIBILITIES:

1. Play a key role in the safe, efficient and effective IP preparation in clinical trials.
2. Review and provide input on IPPI, Site Investigational Product Procedures Manual (SIPPM),
monitoring guidelines and all specific forms related to IP preparation and dosing before finalization as
applicable.
3. Process risk assessment review where applicable.
4. Assist in site/pharmacy assessments, pre-trial site/pharmacy assessment activities and/or study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team.
5. Close collaboration with the Drug Product Development (DPD) team and the Drug Preparation
Administration Team (DPAT) around IPPI.
6. Attend primary kickoff meeting as ad hoc member as needed.
7. Early connection with investigational site pharmacy and IP administration staff to review site IP
process and equipment.
8. Close collaboration with Trial Leaders, CRAs, Trial Manager, Independent Drug Monitor (IDM) and Site Investigational
Product Specialist (SIPS) for all IPPI related topics.
9. Evaluate and support process for IP and ancillary supplies/preparation kits are compatible with the pharmacy equipment/practice in the country/investigational site.
10. Review of site's preparation and accountability records to ensure key information is captured and
documented.
11. Review translation of IPPI and/or related documents into local language per policy and regulations.
12. Provide feedback on eCRF setup regarding IP preparation.
13. Collaboration on IP training material development with key stakeholders.
14. Attend key site initiation visits. Responsible for training of all versions of IPPI through dose escalation and preparation according to internal Standard Operating Procedures (SOPs)/Work Instructions (WIs)/Instructions for Use (IFUs) and policies. Support IP issue resolution and work closely together with the Independent Drug Monitor to ensure site training for blinded trials.
15. Set up and attend mock runs on IPPI preparation before first formal IP preparation at the investigational site if applicable.
16. Observe first IP preparation on site and/or support CRA/Independent Drug Monitor/SIPS if allowed according to local
guidelines and blinding requirements.
17. Point of contact for the internal study team in the country for questions related to the IP preparation.
18. Review any modification of IPPI, SIPPM manual, specific forms related to IP preparation and dosing
during the applicable phases of the trial.
19. Fully document trial related activities with respect to IPPI site training and monitoring (e.g. writing of visit reports and completion of follow-up letters to investigators). Documentation and escalation of major deviations and issues to appropriate stakeholders. Ensure timely corrective actions are completed and documented. Coordinate documentation with CRA/ Independent Drug Monitor, as appropriate.
20. Lead and/or participate in special initiatives as assigned for IPPI and SIPPM development.

Establish and maintain good and productive working relationships with internal and external stakeholders (e.g.
pharmacists, investigators…).