Hector Robertson

Background

About Hector Robertson

Professional Summary As an Associate Director of Data Management (ADDM), I provide leadership of clinical data management activities across one or more clinical development programs that are low to high complexity and enabling planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and market acceptance. As the ADDM, I am also the primary point of contact to the wider clinical trial team for clinical trial data related matters such as coordinate activities across all clinical data management process, clinical data acquisition and standards, and medical coding to ensure cohesive support to clinical trial data collection, review, and reporting. Additionally, I provide a consistent approach to the gathering of data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data including ensuring adherence to defined standards, and also the responsibility for user acceptance testing to ensure high quality deliverable and inspection readiness at all times. As the ADDM, I am also accountable for CRO executed studies, implementation of the Data Quality Oversight Plan (DQOP) and for vendor oversight and ensure the CRO delivers quality data and documents. For internally run studies, I have implemented Data Quality Management Plan (DQMP) to define and document the data quality review strategy for each clinical trial. I have developed DQMP in collaboration with various study stakeholders (e.g. statistics, medical, safety, development, GCO, etc.), enabling the quality review of patient data. I have developing a strong and productive working relationship with all key stakeholders with the ability to think strategically across our broad portfolio and effectively expressing clear views to senior management. Summary of Qualifications: Thorough understanding of data management with vast work experience Excellent managerial skills with ability to handle a team of expertise in clinical research Tremendous command over spoken and written English Highly encouraging and motivating temperament Highly professional approach towards the assigned job Extra ordinary ability of maintaining coordination between functional groups