the Dynamics of Clinical Data Management
StokmanPharmaConsulting. Outside support with inside knowledge.
Peter G. W. STOKMAN, MSc
Director Clinical Data Management with wide and international (expat US) experience in pharmaceutical development. Strategic and operational leadership roles in operational excellence, global harmonization, post-merger cultural, procedural and technical integration, restructuring, staff development. Led groups in attaining the next level in their development. Leadership roles in professional organizations give front row access to current developments and best practices in Clinical Data Operations. Consistently successful by combining strategic thinking, disciplined execution & convincing communication.
Bayer Pharma AG, Berlin, Germany September 2015 - Present
Clinical Data Sciences & Analytics, Clinical Data Management, Business Improvement Consultant
Grünenthal GmbH, Aachen, Germany September 2016 - December 2016
Global Innovation, Development, Clinical Data Management, Business Improvement Consultant
Merck, Sharp & Dohme, Oss, the Netherlands 2012 – 2015
Head Global Data Management & Standards (GDMS), Oss
Schering-Plough, Oss, the Netherlands 2008 – 2012
Senior Director Global Clinical Data Management (GCDM)
Organon International, Oss, the Netherlands
Director Clinical Data Management 2003 – 2008
Interim Head Clinical Supplies Management 2002 – 2003
Responsible for managing critical issues in the Clinical Supplies Management process. Solved the most acute problems, root causes were identified and a foundation was laid for a sustainable solution.
Organon Inc., Clinical Development Department, West Orange, NJ, USA
Clinical Research Scientist / Trial Manager 2001 - 2002
Responsible for preparation and execution of clinical studies in support of Andriol™, testosterone derivative for androgen substitution. Studies were executed on time and within budget.
Associate Director Regulatory Affairs 1999 - 2001
Responsible for Regulatory Affairs related to approved and new products in the therapeutic areas of Fertility and Androgen Substitution. On-time submission of two original NDAs for recombinant FSH
(Follistim™) and one IND (Andriol™, testosterone derivative for androgen substitution).
Participated as Regulatory representative in PricewaterhouseCoopers-led cross functional R&D process improvement project ('Time Compression Initiative' Japan), leading to a significantly improved alignment between the Japanese and the global development process.
Organon International, Oss, the Netherlands
Global Project Director 1994 – 1999
Team lead of four globally operating Compound Project Teams encompassing chemical, pharmaceutical, pre-clinical, clinical and regulatory development of new products for Oral Contraception and Hormone Replacement Therapy.
Responsible for timelines and quality of three US NDAs for oral contraceptives. All three NDAs were approved by the FDA.
Company representative in EFPIA Working Group Endocrine Disrupting Chemicals in the Environment.
Project Leader Working Group Environmental Fate of Estrogens. The project team was the first group in the world to show that ethinyl estradiol (key compound of oral contraception) is biodegradable.
Regulatory Product Specialist 1989 – 1994
Responsible for regulatory and scientific support for existing and developing products in reproductive endocrinology (Gonadotropic Hormones, Androgens, Mechanical Contraception). Maintenance of regulatory approvals worldwide. European submission of several ANDAs, and NDA for recombinant FSH (Puregon™). Author and co-author of position papers, expert reports and publications.
National Institute for Public Health and the Environment (RIVM) Bilthoven, the Netherlands 1986 – 1989
Responsible for the assessment of Toxicology, Pharmacology and Preclinical and Clinical Pharmacokinetics of New Drug Applications submitted to the Dutch Medicines Control Agency (College ter Beoordeling van Geneesmiddelen, CBG).
MEMBERSHIP OF PROFESSIONAL ORGANIZATIONS
2015 Trustee International Network of Clinical Data Management Organizations (INCDMA)
2014 European Task Force Society for Clinical Data Management (SCDM); Co-organizer/Session Chair 1st European SCDM Management Forum,
2005 - Present: Core Committee member of Drug Information Association CDM Community
Elected Chairperson (September 2014)
2003 - Present: DIA: Program Committee Member, Program Advisor, Session Chair and Speaker at many EuroMeetings and Clinical Forum Meetings.
1987 - Present: Dutch Pharmacological Society (Nederlandse Farmacologische Vereniging).
Please reach out for information on options & availability:
Peter G. Stokman, MSc
Oss, the Netherlands
+31 (0)6 1909 3992