Anna Castro-Malek
Full Name
Ms Anna Castro-Malek
Job Title
Associate Director, Clinical Site Budgets and Contracts
Company
Astellas Pharma Global Development
Speaker Bio

Prolific experience in leading global clinical budget and contracts team. Industry expert in developing and building of Investigator Site Budget on global basis from clinical study protocols, phases I to IV and non-interventional studies in oncology, nephrology, urology, infectious disease, ophthalmology, muscle dystrophy, other rare diseases, gene therapy and pain studies. This includes creating budget projections, site rate cards and identifying potential issues or targets in budget that may help or hinder in subject recruitment and budget projections for due diligence. Highly experienced in site budget and contract negotiation.

Extensive knowledge on country specific research reimbursement and global compliance.

Led teams in working contracts staff, clinical staff, and outside vendors, such as clinical research organizations (CROs) to help ensure that all fees and procedures are captured correctly.

Extensive knowledge of ICH-GCP and medical coding that I personally use when creating budget to ensure that everything are within compliance parameters.

Extensive Knowledgeable on global study start up requirements.