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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Data Management and Reporting, utilizing tools such as SQL, Python, and Power BI to support clinical programming and analytics. Strong understanding of FDA regulations, GxP guidelines, and the System Development Lifecycle is essential for effective collaboration and problem-solving in clinical research environments.
Highest-signal resume keywords
Clinical Data ManagementSQL/PL SQLPower BIGood Clinical Practice (GCP)FDA Regulations
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Data ManagementData ReportingData ReviewData ProcessingData EntryClinical ProgramsClinical ResearchPythonSASDatabricks
Soft Skills
Excellent CommunicationOrganizational SkillsProblem-SolvingMultitaskingCustomer Focus
Tools & Technologies
OracleVeevaMS WindowsMS OfficeWeb-Based Applications
Industry Keywords
Drug Discovery ProcessesGxP GuidelinesICHSystem Development Lifecycle ManagementClinical Monitoring
Tech Stack
Tools & technologiesOraclePythonSpringSQL
About the role
Key responsibilities & impact- Assume responsibility for clinical programming, reporting, and analytics deliverables using Oracle, Veeva platforms, and external clinical-study data
- Design, build, maintain, test, and document data reviews based on written specifications
- Review technical feasibility of study-team programming and reporting proposals and implement them
- Communicate issues and ideas across the team and understand study protocols
- Support data-cleaning, medical-review, clinical-monitoring, and safety-report development and reporting
- Provide ongoing support for In-Life Reports
- Fully document, obtain sign-off for, track, and report Change Requests and Incident Reports to upper management
- Participate in study-improvement task forces, automation initiatives, new-system testing, training, and mentoring
Requirements
What you’ll need- B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant Pharma skills and experience
- Must currently hold a B.A. or B.S. degree in a preferred field, or receive one no later than spring 2027
- Good technical proficiency in Clinical Data Management/Reporting Systems such as Power BI, SQL/PL SQL, Databricks, Python, SAS, and AI-related tools
- Solid knowledge of MS Windows/Office software and exposure to web-based applications
- Solid knowledge of System Development Lifecycle Management and system validation
- Ability to establish and maintain working relationships with different functional areas
- Strong customer focus and sense of urgency
- Excellent communication, organizational, problem-solving, multitasking, and independent-work skills
- Desire and ability to learn new processes and technologies
- Understanding of drug discovery processes, FDA regulations, GxP guidelines, and ICH
- Required skills include Clinical Data Management, Clinical Programs, Clinical Research, Data Entry, Data Management, Data Processing, Data Reporting, Data Review, Good Clinical Practice (GCP), and Protocol Management
- US and Puerto Rico residents only
- Valid driving license required
- No visa sponsorship
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Hybrid flexible work arrangement
- 10% travel requirement
