Aditya Mittra
Angestellt, TMF QC Management & Oversight Lead (Global- Associate Director), Novartis
Hyderabad, Indien
Werdegang
Berufserfahrung von Aditya Mittra
Bis heute 7 Jahre und 2 Monate, seit Mai 2017
TMF QC Management & Oversight Lead (Global- Associate Director)
Novartis
- Core member of TMF Governance Office with key accountability in ensuring organizational commitment to TMF Quality Standards and Regulatory Compliance - Global lead managing multi regional team of TMF QC Managers and Specialists at Hyderabad, Basel and East Hanover - Collaborate with QA, Clinical Trial Leadership and Document Governance teams to ensure TMF Inspection Readiness - Vendor oversight and management
1 Jahr und 1 Monat, Apr. 2016 - Apr. 2017
Group Head - CRS (Associate Director) - Oncology Clinical Development
Novartis
Management of team of Clinical Research Specialist (CRS)and CRS Manager ensuring support towards successful execution of global clinical trials. Additionally, support specific projects for CTMR including development of CDMS and Regulatory inspections (Malaysia).
2 Jahre und 8 Monate, Sep. 2013 - Apr. 2016
Manager- Clinical Research Specialists
Novartis
Functional and Operational management of a high-performance central team in Global Oncology Business Unity with reporting lines in India and US. The team supports global Regulatory Submissions, TMF Documentation, Inspection/Audit Readiness, and Drug Supply Management. Key objectives of the team are Standardization of processes across the organization, Process Improvement and Specialization.
1 Jahr und 6 Monate, Apr. 2012 - Sep. 2013
Compliance Oversight Lead (Global) In sourced
Pfizer Inc.
Oversight of clinical trial Projects to ensure patient safety and quality execution. Strategic Planning ; Risk assessment based on Project specificity; Developing risk mitigation plans, site review plans, quality oversight plans; risk analysis; trending, ; Liaising with Business units, Alliance Partners and Site management; ensuring Inspection/Audit readiness by conducting quality review visits. Global Oversight responsibilities include 8 countries across Europe and Latin America
2 Jahre und 8 Monate, Sep. 2010 - Apr. 2013
Regional Lead- Monitoring Group & Study Management ( In sourced )
Pfizer Inc.
Regional Lead of the monitoring group- north and south; responsible for site quality for over 40 sites and ensuring inspection readiness across the region; line management of about 12 monitors across regions; hiring; training; mentoring; resource forecasting; assigning and assessment of the monitoring group; operational management of the regions. Complete study management.
4 Jahre und 1 Monat, Sep. 2006 - Sep. 2010
Clinical Research Associate (Senior/Lead)- In sourced
Pfizer Inc.
Clinical Research Site Monitoring and Management, Site Assessment and Selection, Conduct of Feasibility Studies, Site Training, Mentoring and Training of CRAs, Site Initiation and Close-out conduct, Site Preparation for Audits/Reviews, Regional Development .
Ausbildung von Aditya Mittra
- Bis heute
Pharmacy
CCS University
Business Administration (MBA)
Sikkim Manipal University
Total Quality Management