Amara Sesay
45 Wilkinson Street, Freetown, Sierra Leone
+232 76 445 821 | amara.sesay@email.com | linkedin.com/in/amarasesay

PROFESSIONAL SUMMARY

Results-driven Senior Lead Clinical Data Manager with 15+ years of progressive experience in pharmaceutical clinical research and data management. Proven expertise in leading global clinical trials across all phases, with specialized focus in oncology and complex therapeutic areas. Demonstrated success in managing cross-functional teams, ensuring regulatory compliance, and delivering high-quality data for regulatory submissions. Strong background in electronic data capture systems, CDISC standards implementation, and quality management processes.

PROFESSIONAL EXPERIENCE

Senior Lead Clinical Data Manager
Meridian Pharma Solutions, Basel, Switzerland
January 2020 – Present

• Lead clinical data management activities for 8+ global Phase II-IV oncology trials with patient populations exceeding 2,000 subjects across 25+ countries
• Manage team of 12 data managers, programmers, and data coordinators, providing mentorship and technical guidance on complex protocol requirements
• Oversee development and implementation of data management plans, edit check specifications, and data validation procedures ensuring 99.8% data quality metrics
• Collaborate with biostatistics, medical writing, and regulatory affairs teams to ensure timely database locks and support NDA/BLA submissions
• Lead vendor selection and management for EDC systems and external data management services, achieving 15% cost reduction while maintaining quality standards
• Implement SDTM and ADaM datasets in compliance with CDISC standards and regulatory requirements for FDA and EMA submissions
• Conduct audit readiness activities and serve as primary data management representative during regulatory inspections and internal audits
• Drive process improvements resulting in 20% reduction in database lock timelines and enhanced data quality across portfolio

Clinical Data Manager
Innovate Clinical Research, London, United Kingdom
June 2015 – December 2019

• Managed end-to-end clinical data management activities for 5 Phase I-III trials in oncology and neuroscience therapeutic areas
• Designed and validated electronic data capture databases using leading EDC platforms, ensuring GCP compliance and data integrity
• Developed and maintained data management documentation including DMP, data validation plans, and user acceptance testing protocols
• Coordinated medical coding activities using MedDRA and WHO Drug dictionaries, ensuring consistency and quality across studies
• Collaborated with clinical operations and site personnel to optimize data collection processes and resolve data queries within established timelines
• Conducted data review meetings and provided training to clinical sites on EDC systems and data entry standards
• Supported regulatory submissions by providing data management documentation and responding to health authority queries

Associate Clinical Data Manager
Nexus Therapeutics, Dublin, Ireland
March 2012 – May 2015

• Performed database design, validation, and maintenance for Phase I-II clinical trials across multiple therapeutic areas
• Created edit check specifications and validation rules to ensure data quality and protocol compliance
• Generated data quality metrics reports and performed regular data reviews to identify and resolve discrepancies
• Coordinated with CROs and external vendors on data management deliverables and timelines
• Participated in User Acceptance Testing for EDC system upgrades and new study builds
• Assisted in preparation of data management sections for clinical study reports and regulatory documents

Clinical Data Coordinator
Atlantic Clinical Services, Cape Town, South Africa
August 2009 – February 2012

• Supported data management activities for early-phase clinical trials including database setup and data entry oversight
• Performed data quality checks and generated discrepancy reports for clinical site follow-up
• Maintained trial master file documentation and ensured compliance with GCP and regulatory requirements
• Assisted in development of data collection forms and case report form design
• Provided EDC system support and training to clinical research coordinators and site staff

EDUCATION

Master of Science in Clinical Research
University of London, London, United Kingdom
Graduated: 2009

Bachelor of Science in Biomedical Sciences
Fourah Bay College, Freetown, Sierra Leone
Graduated: 2007

CERTIFICATIONS

• Certified Clinical Data Manager (CCDM) – Society for Clinical Data Management
• Good Clinical Practice (GCP) Certification
• CDISC SDTM and ADaM Implementation Training

TECHNICAL SKILLS

Clinical Data Management: Electronic Data Capture (EDC) Systems, Database Design, Data Validation, Edit Check Programming, CDISC Standards (SDTM, ADaM), Medical Coding (MedDRA, WHO Drug, ICD-9-CM)

Software & Tools: SAS Programming, Microsoft Excel (Advanced), Microsoft Word, Statistical Analysis Support

Quality & Compliance: Good Clinical Practice (GCP), Quality Assurance, Quality Control, Regulatory Requirements, Audit Preparation, Internal Audit Support, Data Integrity

Therapeutic Expertise: Oncology, Cancer Research, Biomarkers, Neuroscience

Project Management: Cross-functional Team Leadership, Vendor Management, Outsourcing, Resource Planning, Budget Management

LANGUAGES

• English (Native)
• French (Professional Working Proficiency)
• Krio (Limited Working Proficiency)

PROFESSIONAL SKILLS

• Strategic Leadership and Team Development
• Cross-functional Collaboration and Communication
• Regulatory Submission Support
• Process Improvement and Optimization
• Stakeholder Management
• Risk Assessment and Mitigation
• Training and Mentorship

PROFESSIONAL AFFILIATIONS

• Society for Clinical Data Management (SCDM) – Member
• Drug Information Association (DIA) – Member