Clinical project management: your study delivered on time and on budget
I coordinate and oversee your clinical studies from protocol to close-out, in line with regulations, timelines and budget. You get a single point of contact who knows the field.
What I take care of
- Operational protocol review: feasibility, visit flow, burden for sites.
- Design and writing of study documents: CRF, monitoring plan, guidelines, study-specific procedures, SAE and device deficiency forms.
- Feasibility studies, site selection and approval.
- Investigator contracts, French hospital agreements (convention unique) and vendor contracts.
- Budget tracking (fees, hospital costs) and logistics (equipment, kits, supplies).
- Patient recruitment follow-up and recovery plans when enrolment lags.
- Monitoring report review, quality control and deviation management.
- CRA and site team training, investigator meetings.
- Vendor selection and coordination (data management, central labs, imaging).
Frequently asked questions
What sponsors, CROs and sites most often ask me before a mission starts.
Can you take over a study already under way?
Yes, it is a frequent request. I start with a status review (TMF, site status, recruitment, budget) and propose a recovery plan within two weeks.
How large a team can you manage?
I have managed teams of 8 to 10 people as clinical development manager. Scope is defined with you according to the number of sites, countries and study phase.
Need help with this?
Leave your details and a few words about your study: I will get back to you within 2 business days.