Tryphosa Gera
Clinical Data Analyst
South Plainfield,NJ
Summary
Detail-oriented team player with strong Interpersonal and organizational skills. Strong knowledge of GCP, ICH and regulatory requirements. Proven Track record of ensuring data quality, integrity and compliance with regulatory standards. Familiarized in data visualization and statistical analysis tools. Hardworking and passionate job seeker eager to secure entry-level clinical data management position. Ready to help team achieve company goals.
Overview
4
4
years of professional experience
6
6
years of post-secondary education
Work History
Clinical Data Manager
Algorithme Pharma
09.2016 - 03.2018
- Performed development and review of study documents like eCRF Completion Guideline, Data Management Plan, External Data Reconciliation guideline.
- Reduced data discrepancies through implementation of robust validation checks and error resolution procedures.
- Prepared and executed test scripts for database User Acceptance Testing (UAT)
- Performed thorough review of clinical protocols to identify potential risks or inconsistencies in study design.
- Coordinated efforts with biostatistics teams for insightful analysis reports that informed key decision-making processes.
- Managed transition to electronic data capture systems, resulting in increased productivity and reduced manual errors.
- Assisted with database upgrades and migrations by performing user acceptance testing.
- Minimized manual system errors with streamlined data entry process.
- Ensured quality, compliance and privacy of data by following GDP and GCP guidelines.
- Performed out of Range checks for Lab data. Handled Lab normal handling conventions documents and also maintained Lab administration module or Metadata form in backend of database.
- Performed SAE reconciliation. Maintained clarification tracker to coordinate with vendor for any kind of issues on data with sender.
- Enforced strict data validation rules to maintain accuracy and completeness of clinical data.
- Coordinated controlled review of data ( source data verified or not, PI signatures completed or not) prior to database lock.
- Comply with institutional policies, standard operating procedures (SOPs) and other guidelines.
Clinical Data Coordinator
Cytel
03.2014 - 05.2015
- Played an integral role in preparing final study reports, utilizing expert knowledge of dataset structures and content.
- Continually sought opportunities for professional growth, staying current with industry trends and best practices in clinical data management.
- Extensively worked with database developers on the design, data model, testing and implementation of study databases.
- Worked on medical coding dictionaries like MedDRA, WHO Drug and in integration of OC and TMS.
- Generated queries to clarify and improve the quality of data, resolve them or initiate their resolution either via clinical research associate or directly with the investigational site or relevant departments.
- Learned industry best practices in CRO clinical study procedures and data management.
- Streamlined data entry and review procedures for improved efficiency and reduced errors.
- Collaborated with cross-functional teams to ensure timely completion of clinical trials.
- Facilitated clear communication between stakeholders through concise status updates and informative progress reports.
- Participated in quality assurance reviews to verify accuracy and reliability of data.
- Enhanced data accuracy by implementing thorough quality control processes in clinical data management.
- Improved overall clinical trial outcomes by maintaining strict adherence to established timelines and milestones throughout all stages of the process.
- Liaised with IT department to address technical issues related to EDC systems, minimizing downtime during critical periods.
- Assisted in the development of study protocols, contributing to the design of effective clinical trials.
Education
Master of Science - Chemical Engineering
Dr. B.R.Ambedkar National Institute of Technology.
Punjab, India 04.2012 - 08.2014
Bachelor of Science - Biotechnology
Jawaharlal Nehru Technological University
Kakinada, India 06.2008 - 06.2012
Skills
Data reporting
Data Interpretation
Electronic Data Capture
Data Cleaning
HIPAA knowledge
Accurate Documentation
Effective Communication
Discrepancy management
SOP Development
Multitasking Abilities
User Acceptance Testing
Timeline
Clinical Data Manager
Algorithme Pharma
09.2016 - 03.2018
Clinical Data Coordinator
Cytel
03.2014 - 05.2015
Master of Science - Chemical Engineering
Dr. B.R.Ambedkar National Institute of Technology.
04.2012 - 08.2014
Bachelor of Science - Biotechnology
Jawaharlal Nehru Technological University
06.2008 - 06.2012