Experience

the Dynamics of Clinical Data Management

SPC

StokmanPharmaConsulting

StokmanPharmaConsulting. Outside support with inside knowledge.

Peter G. W. STOKMAN, MSc

 

SUMMARY

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.

 

PROFESSIONAL EXPERIENCE

 

StokmanPharmaConsulting

 

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

  • Responsible for the delivery of high-quality, timely and cost-effective data operation services of European GDMS group for in-house and outsourced clinical studies (70 FTE; EDC Database Design, Programming & Testing, Vendor Qualification and Management, Standards Development, IVRS/PRO development, Project Data Management, Pharmacovigilance Case Processing).
  • Led group in the expeditious transformation into a well-aligned, high-performance unit in the Global Clinical Development landscape (with sites in the US, South America, Europe and Asia, and multiple external strategic partners), meeting and exceeding strategic, operational and financial targets.
  • Successfully tackled numerous complex challenges through multiple transitions towards one common technical architecture, leading to significant financial synergies and alignment with strategic goals.
  • Developed new and very successful clinical data operations services.
  • Member of global Merck GDMS Leadership Team; participating in the development & implementation of strategic and operational improvement initiatives.
  • Member of global cross functional clinical Operational Leadership Team to prevent/resolve development issues with internal and external stakeholders.

 

Schering-Plough, Oss, the Netherlands 2008 – 2012

Senior Director Global Clinical Data Management (GCDM)

  • Accountable for all Data Operations deliverables of European GCDM group (45 FTE).
  • Led former Organon global clinical data operations HQ group in the transition into a fully integrated and very successful group in the Schering-Plough Global Clinical Operations organization.
  • Co-chair of cross functional Clinical Quality Management Improvement Project, SOP work stream.

 

Organon International, Oss, the Netherlands

Director Clinical Data Management 2003 – 2008

  • Developed global strategy
  • Initiated cultural change and implemented new global systems & processes, including - but not limited to - the global adoption of Electronic Data Capture, outsourcing of parts of Data Operations to a strategic CRO partners, adoption of CDISC standards and SAS capability within CDM, and the adoption of a flexible resourcing model
  • Lean 6-Sigma overhaul led to a significant reduction of operational costs, an improvement of speed and quality KPIs, and a strongly increased added value of CDM to the overall business and financial strategy.

 

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

Reviewing Scientist

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

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