Ninad Satam

About Ninad Satam

Ninad is a senior pharmaceutical professional with 17 years of experience in clinical research managing global, regional and local clinical trials.He has managed phase II and global clinical trials (GCTs), local phase IV observational studies, retrospective and prospective real world evidence (RWE) studies, registry studies and investigator sponsored trials (ISTs) as a part of new product development teams in global pharma MNCs and CROs.He is well versed with the quality management system (QMS) for commercial, medical, regulatory and drug safety divisions.He has lead a team of 11 CR personnel which included 6 Sr. CRAs and 5 CRAs in terms of their compliance to ICH GCP and client\'s SOPs. He has also been a back-up line manager for the team of 8 clinical trial associates/assistants (CTAs).He has an expertise in handling internal process audits, investigator site audits and regulatory (US FDA and DCGI) inspections.He has excellent schedule (portfolio, program and project), resources (time and conflict), risk and cost management skills.He has successfully negotiated budgets and contracts with the investigators, vendors, business development, procurement, legal and finance teams to ensure timely delivery of projects.He has working knowledge of New Drugs and Clinical Trials Rules, 2019 for India and clinical trial regulations in US, UK, EU, Japan, Philippines, Mexico, Brazil, Russia, China and Turkey.He has received recommendations from senior leadership team (SLT) of sponsor companies and CROs.In his free time, he likes to guide pharmacy students, read business and technology articles, autobiographies, non-fictional novels and play table tennis.

Experience

1. Local Study Associate Director

   AstraZeneca

   Jul 2023 — Present · Mumbai, IN

   Leads Local Study Team for assigned study/studies. Leads the site selection process by identifying potential sites/investigators. Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority. Ensures timely preparation of the country\'s financial Study Management Agreement (fSMA) and maintains an accurate study budget. Ensures timely preparation of local Master CSA (including site budget) and amendments as needed. Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.Plans and coordinates applicable to local drug activities. Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations. Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level. Reviews or oversees the review of monitoring visit reports and pro-actively advices the monitor(s) on study related matters. Proactively identifies risks and facilitates resolution of complex study problems and issues. Develops, maintains and reviews risk management plan on the country level. Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies. Ensures accurate payments related to the study are performed according to local regulations and agreements. Participates in training and coaching new members. Ensures completeness of the eTMF to maintain the eTMF “Inspection Ready”. Ensures that all study documents are ready for final archiving and completion of local part of the eTMF. Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.

Education

• SVKM's Narsee Monjee Institute of Management Studies (NMIMS)

  Executive MBA - Pharmaceutical Management, Pharmaceutical Sciences

  2017 — 2019

• Bombay College of Pharmacy (BCP)

  Pharmaceutical Science

  2001 — 2005

• Northeastern University

  Masters of Science, Pharmaceutical Sciences

  2006 — 2008

Skills

• Training & Development
• Clinical Development
• Endocrinology
• Respiratory Disease
• Cardiology
• Ich-Gcp
• Patient Recruitment
• Medicine
• Strategic Communications
• Regulatory Submissions
• Psychiatry
• Regulatory Requirements
• Quality Assurance
• Clinical Trials
• Pharmaceutical Industry
• Sop
• Fda
• Edc
• Ctms
• Pharmacovigilance
• Project Implementation
• Gmp
• Clinical Data Management
• Oracle Clinical
• Neurology
• 21 Cfr Part 11
• Budget Negotiation
• Cardiovascular Medicine
• Pharmaceutics
• Oncology
• Urology
• Protocol
• Compliance Management
• Clinical Site Management
• Biotechnology
• Ecrf
• Quality Auditing
• Clinical Trial Management
• CRO
• Diabetes