Clinical Data Associate Cover Letter

I submit this application to express my sincere interest in the clinical data associate position.

Previously, I was responsible for relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Expertise in Oracle Inform Design
• Knowledge of clinical research, FDA &
• Proficient experience using commercial clinical data management systems and/or EDC products
• Familiarity with MedDRA/WHO-Drug coding
• Knowledge of risk-based monitoring principles and associated analytics/metrics
• Proven experience in vendor oversight to meet aggressive timelines of high quality data deliverables
• Demonstrated successful experience in all relevant clinical data management activities in a BioPharmaceutical or CRO setting
• Strong Project and Risk Management

I am excited to be applying for the position of clinical data associate. Please accept this letter and the attached resume as my interest in this position.

In my previous role, I was responsible for appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators.

Please consider my qualifications and experience:

• Experience with relational database design and development (Microsoft SQL Server or Oracle) preferred
• Experience with REDCap secure research data application
• Proficiency in MS Access and MS Excel including macro design and use
• Advanced analytical, conceptual and technical problem-solving abilities
• Proficient with Microsoft Office applications, including Word, Excel, Outlook, Visio and PowerPoint
• Possess management experience
• Proficient on the design and validation of data collection instruments
• Experience in solving extremely complex and increasingly difficult problems, independently taking the appropriate corrective action, and identify and implement improvements

I would like to submit my application for the clinical data associate opening. Please accept this letter and the attached resume.

Previously, I was responsible for clinical Evidence subject matter expertise and consultation to Clinical Research Associates, Clinical Program Managers, Regulatory Affairs, Clinical Safety, Clinical Compliance, Quality Assurance, Medical Communications and other internal and external stakeholders.

Please consider my qualifications and experience:

• Clinical data management experience preferred
• Consistent, detail-oriented, communicative, dedicated to excellence
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, Powerpoint)
• Experience related to analyzing data and developing conclusions
• Experience with Oracle, InForm or Rave
• Technical experience preferred in a pharmaceutical development environment
• Prior successful troubleshooting of IT systems and enterprise applications in a pharmaceutical development environment (Phase I-IV trials)
• Knowledge of Electronic Data Capture (EDC) database design and functionality, Interactive Response Technology (IRT) functionality and relationship to EDC

Please consider me for the clinical data associate opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for clinical leadership to the interdisciplinary MagellanRx Medical Pharmacy Utilization Management - Clinical Operations team, which includes clinical/medical.

Please consider my qualifications and experience:

• Experience in working in a global team setting
• Act as a team player in client and internal projects/initiatives
• Serve as Clinical Data Scientist for clinical trials assuming responsibility for all DM&M activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence
• Act as the key scientific and technical data management expert
• Ensure work carried out by DM providers is in accordance with applicable SOP’s and working practices
• Data Integrity planning and ongoing monitoring of conformance of data quality to plan over multiple assets, through the implementation of customize central data monitoring strategies using appropriate tools and analytics
• Development experience utilizing Cerner CCL and PowerInsight
• Strong knowledge of Cerner’s data model and architecture

Please consider me for the clinical data associate opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable.

Please consider my experience and qualifications for this position:

• Articulating data flow (structure and format) from patient to analysis and apply this knowledge to data solutions
• Strong therapeutic/scientific/medical terminology knowledge in the field of research
• Technical knowledge to develop requirements and/or study/project objectives
• Experience with designing and handling of eCOA data
• Strong working knowledge with an electronic data capture (EDC) system Medidata/RAVE
• Proficient on developing request for proposals for external vendor contracts, and on evaluating external vendor contract for project procurement related to process changes and data standards
• Assess corporate goals and business strategies to identify GCDM policies for implementation
• Proficient on implementing corporate strategic plan within the department for process changes and data standards