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Samuel Walter Mayer Watts

Angestellt, Project Manager Operations, ClinFlows
Schwetzingen, Germany

Fähigkeiten und Kenntnisse

Operations Management
Process Optimization
Quality Management
Audit
Operations Manager
Site management
English Language
Management
Pharmaceutical chemistry
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
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
KPI
hands-on mentality

Werdegang

Berufserfahrung von Samuel Walter Mayer Watts

  • Current 4 years and 9 months, since Sep 2021

    Project Manager Operations

    ClinFlows
  • 5 years and 3 months, Jun 2016 - Aug 2021

    Site Management Associate 2

    PRA Health Sciences

  • 4 years and 4 months, Jan 2012 - Apr 2016

    Site Management Associate 1

    PRA Health Sciences

    Completes site management activities for late phase studies to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines.

  • 8 months, Jun 2010 - Jan 2011

    Regulatory Affairs Assistant

    Becton Dickinson Management GmbH & Co. KG

    Interacted with internal clients. Had some limited external interactions when directed by senior staff

Ausbildung von Samuel Walter Mayer Watts

  • 7 years, Jan 2003 - Dec 2009

    Bio-Pharmaceutical Chemistry

    Universidad del Valle de México

Sprachen

  • English

    C2 (Verhandlungssicher / Muttersprachlich)

  • Spanish

    C2 (Verhandlungssicher / Muttersprachlich)

  • German

    A1-A2 (Grundkenntnisse)

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