Soham Shah

Experience

1. Senior Manager, Clinical Study Lead

   Regeneron

   Jun 2023 — Present · Basking Ridge, NJ, US

   Accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out for both internally sourced studies and studies outsourced to Clinical Research Organizations- Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors and performs ongoing oversight to ensure CROs and vendors are in alignment with plan and delivering per scope of work- The Sr Mgr CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP- Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study. Assigns tasks to Clinical Study Management staff and supports their deliverables- Oversees and provides input to the development of study specific documentation including but not limited to: Protocol, Informed Consent For (ICF), case report forms (CRF), Quality risk assessment categorization tool, data management plan, monitoring plan, monitoring oversight plan, project specific training plan, Pharmacy Manual, data review plan, statistical analysis plan, etc- Oversees the execution of the clinical study against planned timelines, deliverables, budget, data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites- Ensure clinical project audit and inspection readiness through the study lifecycle & supports internal audit and external inspection activities and contributes to CAPAs as required- Contributes and drives ongoing process improvement initiatives.

Education

• Visveswarapura Institute of Pharmaceutical Sciences, Bangalore

  Bachelor of Pharmacy (B.Pharm.), Pharmacy

  2004 — 2007

• KLES college of Pharmacy, Belgaum

  Master of Pharmacy, Pharmacy practice

  2008 — 2010

Skills

• Clinical Operations
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Good Clinical Practice (Gcp)
• Clinical Research
• Clinical Development
• Ich-Gcp
• Patient Recruitment
• Vendor Management
• People Management
• Diabetes
• Regulatory Affairs
• Gcp
• Clinical Trials
• Electronic Data Capture (Edc)
• Edc
• Therapeutic Areas
• Pharmacovigilance
• Ctms
• Pharmaceutical Industry
• Regulatory Submissions
• Oracle Clinical