Manager, Clinical Data Management Cover Letter

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

In my previous role, I was responsible for fDA, EMA, and ICH guidance and other regulatory expertise to support internal procedures in maintaining required compliance and to provide awareness and training.

Please consider my qualifications and experience:

• Demonstrated initiative, sound judgment and flexibility
• Experience using SAS/EG to facilitate data review preferred
• Competence with MS Office programs, particularly Word, Excel and PowerPoint
• Self-motivated, collaborative team member
• Passion for outthinking cancer
• Advance knowledge of Data Management
• Effective risk management and problem solving skills
• Experience relevant to area of research

I submit this application to express my sincere interest in the manager, clinical data management position.

In my previous role, I was responsible for leadership and content expertise for Clinical Data Management activities from start-up through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities.

Please consider my qualifications and experience:

• Preserve strong relationships with NIAID laboratories and internal team members through open, efficient and timely communications
• Ensures review and quality control against associated project protocol, NIAID laboratory requirements, CRF standards templates, Good Clinical Data Management Practices (GCDMP), and where applicable CDISC Clinical Data Acquisition Standards Harmonization (CDASH) standards
• Plan and lead database setup with NIAID laboratories, ensuring appropriate database documenting
• Perform database validation User Acceptance Testing (UAT), and document databases in accordance with programming standards and validation procedures
• Understand and comply with Good Clinical Practices (GCP), SOPs, Regulatory requirements and GCDMP
• Meet objectives as assigned and interact with the NIAID project teams to organize timelines, responsibilities and data management deliverables
• Developing, implementing, testing and quality control of new technologies with guidance from the Clinical Trials Data Management team more experienced team members
• Develop clinical data management training and mentorship programs present at Clinical Data Management training events and workshops

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

In my previous role, I was responsible for global oversight and support for global clinical studies management databases and systems, including data collection, accuracy, and reporting.

Please consider my experience and qualifications for this position:

• Knowledge of data entry systems, quality control, basic SQL, dataset creation and maintenance, experience with relational databases
• Previous experience with FDA and Department of health and Human Services (DHHS) regulated clinical research
• Knowledge or regulatory requirements, FDA regulations, GCP, international guidelines, and other guidelines for clinical research
• Strong communications skills, both verbal and written, excellent analytical, organizational and time management skills
• Extensive Data Management experience in a global organisation
• Previous experience at or oversight of outside clinical research vendors (CRO’s, central Labs, vendors, .)
• Lead all activities for complex global clinical trials
• Experience authoring DMPs, SOPs, and training materials

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

In my previous role, I was responsible for clinical study level data management oversight of outsourced clinical trials for phase I / II studies including: project management, vendor management, coordination of internal reviews, and approval of deliverables.

My experience is an excellent fit for the list of requirements in this job:

• Proven expertise in Microsoft Office Suite and related tools and systems
• Expert understanding of clinical data management procedures while identifying applications of functional knowledge and existing methodologies to complex problems
• Frequently interacts with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
• Lead briefings and technical meetings for internal and external representatives
• Capacity to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
• Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions
• Expertise in pharmacovigilance with specific compliance disciplines (non-regulated, GLP, GCP, GDP, GMP or computerized systems) preferred
• Serve as the main contact for NIAID laboratories on data management products and deliverables

I submit this application to express my sincere interest in the manager, clinical data management position.

In the previous role, I was responsible for strategic guidance for the review, development, and maintenance of processes and standard operations to ensure that data management and/or clinical programming activities are in compliance with regulatory and company requirements.

My experience is an excellent fit for the list of requirements in this job:

• Review and development of Data Management SOP and Clinical Trials Data Management Best practice guidelines
• Knowledge of data management processes and systems (specifically clinical data management systems)
• Understanding of clinical trials and the drug development process
• Strong clinical data management capabilities
• Experience with supervision of data management and data entry staff
• Knowledge of Good Clinical Practice, Drug development and clinical trials processes, clinical trial databases and applications, Quality Management, Regulatory filings and inspections, Risks analysis, Process improvement methodologies is essential
• Independence in their assignments
• In-depth knowledge of relevant regulatory guidelines, GCP and international guidelines regarding data management