Patrick Vogt
San Diego,CA
Summary
Clinical Data Management professional with 20+ years’ experience leading Phase I-III studies. Extensive experience in people and project management, CRO and vendor oversight, data cleaning activities, eCRF and database design, and regulatory standards (GCP, ICH). Committed to adopting new technologies to ensure high-quality, compliant data and successful trial outcomes.
Overview
26
26
years of professional experience
Work History
Assoc. Director, CDM
KPS Life on assignment at Acadia Pharmaceuticals
San Diego, USA
05.2025 - Current
- Lead CDM activities (DB builds, study conduct, locks, submission activities) on Phase I-III clinical trials
- Managed CROs and vendors for data collection and transfers, ensuring adherence to study timelines
- Work closely with key stakeholders in Clinical Operations, Clinical Development, Biostatistics, Safety and Programming
- Tracked timelines and data cleaning activities to support timely delivery of accurate data
- Oversaw data review and user acceptance testing for databases, ensuring compliance with study requirements
- TA: Lewy body dementia; Rett syndrome
Assoc. Director, CDM Program Lead
Bristol Myers Squibb
San Diego, USA
01.2021 - 05.2025
- Managed 9 direct reports who led data management activities on Phase II-III clinical studies.
- Oversaw CDM activities on neuroscience programs, managing DB builds, study conduct, locks, submission activities, CRO and internal oversight, budgets, and collaboration with Sr. management and functional teams to ensure timely project delivery.
- Collaborated with standards group to establish and enhance neuroscience data library, improving data accessibility for research teams.
- Served as SDV SME, involved in creating and implementing company’s tSDV strategy.
- Collaborated with department process lead to author key process documents for tSDV, study build, and CRF completion guidelines, standardizing procedures across projects.
- TA: MS; Alzheimer’s disease; Bipolar, Schizophrenia
Sr. Manager, CDM
Bristol Myers Squibb (prev. Celgene)
San Diego, USA
05.2016 - 01.2021
- Led submission DBL as DM Lead on MS study resulting in FDA approval.
- Oversaw studies across all lifecycle phases, ensuring compliance and quality.
- Collaborated closely with project teams to design eCRFs and EDC specifications.
- Led CRF review meetings to align with study requirements.
- Authored critical documents such as Data Management Plans, CRF Completion Guidelines, Coding Guidelines, Annotated CRFs, Data Transfer Specifications, and Edit Check Specifications.
- Oversaw CROs and internal data review teams.
- Conducted training sessions for site staff and data management teams on protocol requirements.
- Managed 5 direct reports.
- TA: MS; Crohn’s/Other Immunological GI diseases
Sr. Manager, CDM
Halozyme Therapeutics, Inc.
San Diego, USA
11.2015 - 05.2016
- Led DM activities on a Phase III oncology trial.
- Successfully launched DB into production in time for FSFV and supported initial study conduct activities.
- Managed CRO team operations to ensure effective project execution.
- TA: Pancreatic cancer
Clinical Data Project Manager
Baxter International
Westlake Village, USA
11.2012 - 10.2015
- Led all CDM activities and deliverables on global Phase III/IV studies.
- Managed DB builds and locks in Medidata Rave and Oracle InForm.
- Coordinated CROs and vendors to ensure alignment with study objectives.
- Reviewed and negotiated vendor contracts to secure favorable terms and compliance.
- Worked with study teams on key documents (eCRFs, protocols, protocol deviation plans, data management plans, safety review plans).
- Participated in workgroups to develop and revise SOPs and process documents for improved operational consistency.
- TA: Primary Immune Deficiency Disease
Program Data Manager, Oncology
Pfizer
San Diego, USA
05.2006 - 10.2012
- Led DM activities on oncology studies, including a submission DBL on a program that led to a subsequent FDA approval for Renal cell carcinoma.
- Designed oncology CRFs with Translational Medicine colleagues to align data collection with study objectives.
- Coordinated with CROs and alliance partners to optimize study execution and improve timelines.
- Monitored project metrics and deliverables, ensuring adherence to deadlines and project milestones.
- Presented EDC training and CRF completion at Investigator Meetings.
- TA: Renal Cell Carcinoma; Breast Cancer; Prostate Cancer
Clinical Study Operations Manager
Pfizer
San Diego, USA
11.2004 - 04.2006
- Managed CDM and clinical operations for Phase III studies, ensuring alignment with project objectives.
- Oversaw site performance, query responses, database builds, and study locks to ensure timely project delivery.
- Oversaw project timelines, vendor management, and led internal cross- functional team meetings.
- Conducted audits and inspections.
- TA: Small cell lung cancer; Breast Cancer; Prostate Cancer
Sr. Clinical Data Analyst
Allergan
Irvine, USA
11.2003 - 11.2004
- Led CDM activities, ensuring adherence to project timelines and comprehensive documentation.
- Trained and managed CROs to enhance data quality and compliance.
- Facilitated external data transfers, ensuring seamless integration and accuracy.
- Designed CRFs and wrote SOPs/work instructions
- TA: Psoriasis; Metastatic melanoma; Ophthalmology
Clinical Data Coordinator
ICON
Irvine, USA
10.2002 - 11.2003
- Lead Data Manager on assigned Phase II-III studies.
- Created and managed timelines and metrics for clients.
- Reviewed data and issued queries.
- Performed SAE and vendor reconciliation.
- Assisted in audits.
- TA: Lymphoma; Stroke; Lupus
Clinical Data Associate
Vical
San Diego, USA
10.2001 - 10.2002
- Data Manager for Phase I-III studies.
- Reviewed data and issued queries to ensure data integrity and compliance.
- Trained in Oracle database builds and programming.
- Created key DM documents, including DMPs, to facilitate study execution.
- Wrote CDM SOPs and guidelines to standardize processes and enhance data management practices.
- Worked with Safety colleagues to develop AE reporting and tracking system.
- TA: Melanoma; Prostate Cancer; Infectious diseases
Clinical Database Administrator
La Jolla Pharmaceutical Company
San Diego, USA
08.2000 - 10.2001
- Managed all CDM activities for a global Phase II Lupus study.
- Validated the clinical data system (DataFax).
- Reviewed data, issued queries, wrote core CDM documents.
- Participated in on-site monitoring visits with CRAs.
- TA: Lupus
Education
Master of Public Health -
University of South Florida
Tampa, FLBachelor of Arts -
University Arizona
Tucson, AZClinical Research Professional Coursework -
UCSD
San Diego, CASkills
- Database build and lock
- Regulatory submissions
- EDC System Design
- Medidata RAVE
- Veeva Vault
- eCRF design
- eCOA
- Project Management
- Vendor Oversight
- Microsoft Office
- Cross-functional collaboration
Timeline
Assoc. Director, CDM
KPS Life on assignment at Acadia Pharmaceuticals
05.2025 - Current
Assoc. Director, CDM Program Lead
Bristol Myers Squibb
01.2021 - 05.2025
Sr. Manager, CDM
Bristol Myers Squibb (prev. Celgene)
05.2016 - 01.2021
Sr. Manager, CDM
Halozyme Therapeutics, Inc.
11.2015 - 05.2016
Clinical Data Project Manager
Baxter International
11.2012 - 10.2015
Program Data Manager, Oncology
Pfizer
05.2006 - 10.2012
Clinical Study Operations Manager
Pfizer
11.2004 - 04.2006
Sr. Clinical Data Analyst
Allergan
11.2003 - 11.2004
Clinical Data Coordinator
ICON
10.2002 - 11.2003
Clinical Data Associate
Vical
10.2001 - 10.2002
Clinical Database Administrator
La Jolla Pharmaceutical Company
08.2000 - 10.2001
Master of Public Health -
University of South Florida
Bachelor of Arts -
University Arizona
Clinical Research Professional Coursework -
UCSD