Oliver Meier
Angestellt, International Scientific Director Hematology, F. Hoffmann-La Roche Ltd.
Reinach, Schweiz
Werdegang
Berufserfahrung von Oliver Meier
Bis heute 7 Jahre und 5 Monate, seit Jan. 2017
International Scientific Director Hematology
F. Hoffmann-La Roche Ltd.
• Medical/scientific responsibility for clinical studies with MabTera, including medical monitoring, final study reports and preparation of data for publication of study results • In charge of establishing the Independent Data Monitoring Committees (IDMCs) • Contributes medical expertise in cross functional bodies like GDT, LCT and IBT • Provide strategic medical guidance to affiliates/regions, including guidance and information to MSLs (Medical Scientific Liaisons)
3 Jahre, Jan. 2014 - Dez. 2016
Global Study Management Team Leader
F. Hoffmann-La Roche Ltd, Basel
• Lead crossfunctional study management team • Managed clinical study budget and timelines. • Proactively managed actual study level recruitment and data cleaning activities • Maintained oversight of performance, issues, and their resolution and identified systematic issues and coordinated any corrective action as the primary contact with CRO and affiliates • Performed ongoing vendor management, including independent negotiation of scope of work, budgets, performance management, and issue resolution
1 Jahr, Jan. 2013 - Dez. 2013
GMA Training & Medical Standards Leader
F. Hoffmann-La Roche Ltd.
• Lead the piloting of the inspection readiness program PRISM for pharma affiliate studies in close collaboration with PDQ • Designed & delivered high priority Functional Training for medical affairs staff • Refined and communicated Medical Standards and Metrics through the dashboard “Affiliate Passport” • Participated in the project QUDOS to define procedures and processes and to assure Quality Risk Management and Quality Control
5 Jahre und 9 Monate, Apr. 2007 - Dez. 2012
Medical Manager Lymphoma
Roche Pharma (Schweiz) AG
• All aspects related to clinical trials phase II-IV • protocol review, approval and collaborations • Crossfunctional project management • Budget responsibilities • Leading and coordinating training of medical colleagues • Contract negotiations • Filing experience • Reimbursement negotiation • Advisory board moderation • Therapeutic area expert engagements within hemato-oncology • Generation, presentation and publishing of scientific data
2 Jahre und 9 Monate, Aug. 2004 - Apr. 2007
Clinical Trial Specialist
Roche Pharma Schweiz AG
• Communicated feasibility with principal investigators on site followed by contract negotiations and budget proposals • Managed financial payments and study budget • Prepared the study documents for ethiccommittees and regulatory authorities • Initiated clinical trials in rheumatology, dialysis and breastcancer • Monitored clinical studies according to Roche PD-SOP, GCP/ICH and local regulatory regulations • Assured correct safety reporting in function of SAE-Responsible
Sprachen
Deutsch
Muttersprache
Französisch
Fließend
Englisch
Fließend
Italienisch
Gut