Special short-term project to provide leadership during global strategic CRO-pharma partnership build following sudden termination of outsourcing Department Head.
Established Joint Operating Committee and Executive Steering Committee, governance, third party vendor workstreams.
Contributed to MSA and rate card negotiations.
Facilitated tri-partite agreement with two global CRO preferred providers.
Middle interface between outsourcing and clinical operations, data sciences, medical affairs, pharmacovigilance groups.
Developed and implemented two new SOPs for clinical vendor selection and oversight.
Matrix and task management for department of 60+ outsourcing staff.
Clinical Operations leadership during M&A activities, due diligence, etc.
Building a clinical operations team after acquisition, training, ensuring smooth continuity of clinical trials
Small Start Up Biotech
Small Start Up Biotech
Small Start Up Biotech
Clinical Development Operations leadership
Study management
Protocol design, medical writing, designing plans and manuals and site materials
Site Visits (SIVs, IMVs, COVs, PSVs, recruitment booster visits, PI relationship visits)
Vendor set up, team interviewing, scope of work and specifications finalization
Vendor management and oversight visits
Close collaboration with QA on GCP topics/SOPs/CAPAs
Governance set up
CRO budget review and change order negotiation
Fixing CRO performance problems
RFPs for vendors, vendor selection, vendor negotiation and contracting
Data cleaning and review
Clinical Operations input into complex regulatory issues