As we are growing, we are currently looking for a Clinical Trial Manager (CTM).
The CTM is responsible for all operational aspects of the assigned clinical studies from monitoring initiation till closure of the studies. The successful candidate will have clinical trial operational experience in phase I, II and III drug development phases and is an operational expert in the clinical trial activities from start-up, execution until closure and its underlying activities. The CTM will be the “operational clinical trial voice” for the assigned studies, both internally and externally, he or she is owning the timelines of a clinical trial project and is accountable to keep the trial on track. The successful candidate will excel in establishing good and effective internal and external working relationships.
Reporting line
The CTM reports to the Clinical Operations Development Lead (CODL)
Roles & Responsibilities
The CTM is responsible for all clinical operational aspects for the assigned global clinical trial(s) from preparation until closure. The trial responsibilities include:
1. Participate in the clinical trial team meetings, or, in case of a Lead CTM: lead the clinical trial team meetings together with the Lead Trial Physician
2. Oversee risk identification and mitigations for the clinical trials, provide solutions and oversee implementation
3. Oversee all trial related aspects, timelines, budget and quality. Close collaboration with the CODL on changes, issues and potential solutions
4. Ensure that clinical trials are executed according to the Clinical Development Plan (CDP), trial plans, OGSM and in compliance with argenx procedures, ICH-GCP and other applicable legislations
5. Support and participate in CRO and vendor selection
6. Lead CRO contracts negotiations together with the argenx vendor manager
7. Responsible for leading, guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical trial based upon metrics and plan
8. Member of the Country and Site Selection Commission for the specific trial
9. Provide input into and/or develop trial related materials such as clinical protocol, clinical monitoring plans, data management plan, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, patient retention and recruitment materials
10. Oversee and track patient recruitment and pro-actively identifies ways to prevent recruitment delays
11. Develop monitoring and site oversight strategy and oversee adherence to it. Perform site oversight visits according to plan
12. Review monitoring visit reports, protocol deviations and data listings to ensure reliable quality data are delivered and proactively identify and solve issues/concerns
13. Monitor data quality
14. Ensure that the Trial Master File (TMF) is maintained and up to date
15. Ensure timely availability of investigational product supply on site and ensure clinical site accountability records on site are in place and maintained
16. Ensure timely collection, documentation and reporting of Adverse events (AEs) and Serious AEs (SAEs) and collaborate in submission of the reports to FDA, EMEA and other applicable regulatory authorities
17. Ensure supportive relationships with clinical sites and trial personnel
18. Clearly communicate on goals/expectations and motivate team members, including vendors, to work towards achieving clinical trial goals
19. Pro-actively identify and solve issues in the assigned clinical trial and timely escalate them to CODL, Head of Trial Operations and/or Senior Management, as needed
20. Responsible and contact person during inspections/audits for the assigned trial together with the Quality Assurance representative
21. Identify efficiencies, best practices and lessons learnt. Search for and embrace innovation
The CTM will also participate in activities other than trial-related which include but are not limited to:
22. Provide input to the clinical development strategy/plan
23. Provide input to procedures/SOPs/WIs and related documents
24. Participate in workstreams
25. Ensure best practices and lessons learnt are shared across trials/indications/compounds
Skills & Competencies
26. Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical trial
27. Experience with tools and systems for managing clinical studies (MS project, trial progress and metric systems, eCRF databases)
28. Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
29. Minimum of 5 years of experience in Clinical Operations and managing CROs and vendors
30. Biotech experience is a plus
31. Auto-immune and/or oncology clinical trial background is a plus