Samuel Walter Mayer Watts
Schwetzingen
Summary
Forward-thinking professional with expertise in efficiently resolving customer issues and enhancing productivity through detailed task analysis. Proven track record of improving customer satisfaction and managing projects in cross-functional teams. Strong written and verbal communication skills complemented by project coordination experience. Committed to implementing effective management techniques tailored to local needs.
Overview
16
16
years of professional experience
Work History
Project Manager Operations
ClinFlows
Kehl
09.2021 - Current
- Manage decentralized clinical trial (DCT) platform configurations and operational oversight.
- Deliver user training, documentation, and technical support within SOP and regulatory frameworks.
- Advise clients on study design configurations, project feasibility, and workflow optimization.
- Collaborate with product development teams for platform enhancement.
Site Management Associate II
PRA Health Sciences
Mannheim
05.2016 - 08.2021
- Led site management for late-phase observational and PASS studies ensuring operational quality and regulatory compliance.
- Managed clinical trial budget evaluations, deliverable tracking, and operational metric reporting.
- Supported regulatory submissions to Health Authorities and Ethics Committees (EC/IRBs).
- Developed study materials including assessment tools, site initiation guides, and study-specific documentation.
- Conducted remote and on-site qualification, initiation, monitoring, and closeout visits.
Site Management Associate I
PRA Health Sciences
Mannheim
01.2012 - 04.2016
- Maintained study tracking systems, eTMF, and essential document management in compliance with ICH-GCP and SOPs.
- Coordinated SAE reporting processes, safety data review, and reconciliation activities.
- Delivered technical support to sales teams and participated in software validation initiatives.
- Assisted in project feasibility assessments and site recruitment for multinational studies.
Regulatory Affairs Assistant
Becton Dickinson & Co
Mexico City
06.2010 - 01.2011
- Prepared regulatory dossiers for clinical trial submissions aligned with global standards.
- Performed data review, query management, and database reconciliation activities.
- Collaborated with internal and external stakeholders for project and regulatory operations.
Education
Bachelor of Science - Biopharmaceutical Chemistry
Universidad Del Valle De México
Mexico City, Mexico12.2009
High School Diploma -
Sedbergh School
Montebello, Quebec, Canada09.2002
Skills
- Late-Phase Study Operations
- Project management
- Clinical trial coordination
- Effective communication
- Workflow optimization
- Clinical Project Management
- Real-World Evidence (RWE)
- Cross-functional Leadership
- Vendor Management
- Regulatory & Ethics Submissions
- Risk-Based Monitoring (RBM)
- Data Review & Query Resolution
- ICH-GCP Compliance
- EDC Systems (eCRF)
- Budget Management
- SAE & Safety Management
- Process Improvement
- Feasibility Studies
- Investigator Site Management
- Clinical Monitoring (Remote/On-site)
- Data Management & Query Resolution
- Site Initiation Visits (SIV)
- Closeout Visits (COV)
- Clinical Trial Management System (CTMS)
- Electronic Trial Master File (eTMF)
- Vendor Oversight
- SAE Reporting & Safety Management
- Protocol Deviation Management
- Audit Readiness
- ECRF / EDC Systems Management
- Clinical Supply & IMP Management
- Cross-functional Team Leadership
- Milestone Tracking & KPI Reporting
- Budget Forecasting & Control
- Resource Allocation
- Stakeholder Engagement
- Study Start-Up & Close-Out
- Project Status Reporting
- Contract & Vendor Management
- Change Management
- Issue Escalation & Resolution
- Operational Risk Mitigation
- Client Relationship Management
- Operational Excellence Initiatives
- Process Optimization & Lean Methodologies
- Late Phase (Phase IIIb/IV) Studies
- Non-Interventional Studies (NIS)
- Post-Authorization Safety Studies (PASS)
- Expanded Access Programs (EAP)
- Patient-Reported Outcomes (PRO)
- Regulatory Affairs & Submissions
- Ethics Committee (EC)/IRB Submissions
- Global Regulatory Compliance
- Health Authority Interactions
- Clinical Development Plan (CDP)
- Medical Writing Oversight
- Quality Management Systems (QMS)
- Decentralized Clinical Trials (DCT)
- Direct-to-Patient (DtP) Services
- Digital Health Technologies
- Patient-Centric Trial Design
- Real-Time Data Capture
- AI-driven Data Analytics
- EConsent and ePRO/eCOA Platforms
- Risk-Based Quality Management (RBQM)
- Agile Clinical Operations
- ICH E6 (R3) Compliance
- Diversity & Inclusion in Clinical Trials
Languages
- English, Bilingual/Proficient (C2)
- Spanish, Bilingual/Proficient (C2)
- German, Intermediate (B1)
Geographic Operational Experience
- USA
- Mexico
- Chile
- Argentina
- Spain
- UK
- Denmark
- Sweden
- Czech Republic
- Poland
- Netherlands
- Ireland
- Italy
- Israel
- South Africa
Therapeutic Area Experience
- Medical Devices
- Cardio-Metabolic
- Genitourinary
- Hematology
- Infectious Diseases
- Oncology
- Radiology
- Fertility
Timeline
Project Manager Operations
ClinFlows
09.2021 - Current
Site Management Associate II
PRA Health Sciences
05.2016 - 08.2021
Site Management Associate I
PRA Health Sciences
01.2012 - 04.2016
Regulatory Affairs Assistant
Becton Dickinson & Co
06.2010 - 01.2011
Bachelor of Science - Biopharmaceutical Chemistry
Universidad Del Valle De México
High School Diploma -
Sedbergh School