A year with MaaT Pharma: end of assignment
After a little over a year with MaaT Pharma, my assignment comes to an end in the coming weeks. A dual role, Clinical Trial Manager and Clinical Oversight Manager, on an international pivotal Phase 3 programme in haemato-oncology.
I held a dual role there, Clinical Trial Manager and Clinical Oversight Manager, on an international pivotal Phase 3 programme in haemato-oncology.
Start-up
Site feasibility and selection across Europe, the UK, the USA, Turkey, Switzerland and Australia. Site selection SOP and SSV toolkit co-written, start-up tracking tool, submission documents prepared with the Regulatory team, site contracts and budgets through activation. Weekly call with the 10 freelance CRAs on their sites' start-up activities, and weekly call with the Clinical Project Leads.
Oversight
Oversight plan written and implemented, oversight of the CRO (CTMs, CRAs), freelance CRAs and vendors, KPIs, on-site oversight visits with findings followed up to resolution, monitoring report and eTMF reviews, deviations and CAPAs, audit readiness, governance meetings.
What I take away
A committed and caring team, a programme that matters for patients in a critical situation, and the conviction that overseeing a CRO is built on a demanding partnership with its teams as much as on the rigour of the processes.
Thank you to the whole MaaT Pharma team for their trust.
What comes next
I am available at short notice for a new assignment: Clinical Project / Trial Management, Clinical Oversight, Start-Up and Regulatory (EU-CTR, CTIS) or Lead CRA, fully remote with occasional travel possible. A programme to secure in your biotech? Let's talk.
Let's talk