Clinical Data Manager Resume

CLINICAL DATA MANAGER

Proven success in investigation and management of drug safety, development, analysis, and evaluation of toxicity data, and organization of disparate research data. Systematic leader focused on overall accuracy in the administration, reconciliation, and summation of AE/SAE data/clinical trial reviews from multiple sources and the composition of narrative case synopses of reportable adverse events for IRB, DSMB, CTEP, and the sponsor.

* Expert in AE/SAE reporting and the management of drug safety processes, including adverse events classification, grading detailed documentation, and writing case narratives.

* Expertise in FDA, ICH, and GCP regulatory guidelines and policies; generation/analysis of clinical data reports and summaries, quality data, and case summaries.

* Highly skilled in EDC data management, including design and development of eCRFs, discrepancy management, and validation rules creation.

* Performance-driven leader and supervisor focused on mentoring and cultivating excellence.

CLINICAL EXPERIENCE

ABC Services (NIH Contractor), Denver, CO, 20xx-Present

POB-NOB-DB Team Leader / Senior Clinical Data Manager 3 (SCDM3): Collect clinical research/toxicity data from disparate sources, analyze, and input data records in study databases. Establish processes to measure study drug compliance and accountability; report research findings. Lead a team of Senior Clinical Data Managers and Clinical Data Managers across several National Cancer Institute branches, manage schedules, review and assign workload, set expectations, evaluate/quality check work, and execute annual reviews based on objectives.

* Restructured patients’ data to improve timelines and consistency of Oracle Clinical C3D data, and initiated mandatory use of EDC QA/QC tools. Controlled timetables through a ten-day rule that required EDC to input all data within ten days of enrollment. Met the metrics for the first time in three quarters.

* Analyzed, summarized, and assessed AEs from PEs, labs, consultations, and patient diaries based on clinical signs and symptoms; substantiated/determined relationships to the study drug.

* Maintained AE documentation, reconciliations, and responses in databases and developed narrative case synopses of reportable adverse events for DSMB, continuing review, CTEP, and the sponsor.

* Investigated, corrected, and reconciled data inconsistencies across three databases (C3D, Excel, and CDS).

BCD Services (NIH Contractor), Denver, CO, 20xx-20xx

Senior Clinical Data Manager: Contributed to development of operational procedures and data reporting of clinical trials. Ensured compliance with all review/data flow processes and procedures, safety, and FDA requirements. Performed detailed research of experimental drug statistics of R11577/placebo protocol data, presentation of toxicity levels, accumulation/disease progression, adverse events, and placebo database updates.

* Designed/produced a data dictionary to link three databases, the outdated Oracle Clinical Discoverer reporting tool, the OC C3D data collection tool, and Oracle Clinical iReview applications.

* Streamlined data collection, reporting, and organization potential through production and implementation of a CRF tracking inventory log to target missing data. Coordinated, monitored, and verified research data submitted to the National Cancer Institute by seven medical/research centers to enhance levels of correctness, consistency, and compliance.

EDUCATION & PROFESSIONAL DEVELOPMENT

Certified Psychiatrist, Psychiatry/Substance Abuse
XYZ Medical Academy, XYZ University, 20xx

Medical Doctorate, Internal Medicine/Psychiatry
XYZ Medical Academy, XYZ University, 20xx

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