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Data Manager Consultant
ClinChoice. Lead data management activities for clinical trials, including database setup, study conduct, and close-out .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in data management for clinical trials, including database setup, data validation, and compliance with regulatory standards. Proficient in leading cross-functional teams to ensure high-quality deliverables and adherence to timelines.
Highest-signal resume keywords
Data Management ExperienceClinical Trial ProcessesElectronic Data Capture SystemsRegulatory Compliance (SOPs, GCP, ICH)Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Database SetupData Validation PlansUser Acceptance Testing PlansData Transfer SpecificationsEdit Rules/ChecksQuery LogicData Review PlansCase Report Form SpecificationsData Entry GuidelinesSAE Reconciliation
Soft Skills
LeadershipAdaptabilityPrioritizationCollaborationCommunication
Tools & Technologies
Medidata RaveOracle InFormOpenClinicaMedrioMicrosoft Office
Industry Keywords
Clinical ResearchPharmaceutical IndustryClinical TrialsRegulatory RequirementsGCPICH Guidelines
Tech Stack
Tools & technologiesGoogle Cloud PlatformOracle
About the role
Key responsibilities & impact- Lead data management activities for clinical trials, including database setup, study conduct, and close-out
- Ensure study deliverables meet timelines and quality standards
- Collaborate with cross-functional teams to maintain project timelines and deliver high-quality data management deliverables
- Review clinical research documents, including protocols and Case Report Forms
- Create and review electronic Case Report Form specifications
- Develop Data Management Plans, Data Validation Plans, eCRF Completion Guidelines, Data Entry Guidelines, and Data Review Plans
- Develop edit rules/checks, query logic, and query messages
- Develop User Acceptance Testing Plans and test data entry screens and edit checks
- Create and provide training to clinical teams and sites
- Perform ongoing data review and reconciliation activities and provide metrics and patient trackers
- Perform database lock/unlock and freeze/unfreeze activities for statistical review, interim analysis, and final database lock
- Coordinate archiving of study databases and related documents
- Create Data Transfer Specifications and perform external vendor reconciliation
- Perform SAE reconciliation
- Maintain and improve client satisfaction through high-quality service, communication, and clinical data management
Requirements
What you’ll need- Bachelor’s degree in clinical, pharmacy, biological, mathematical sciences, a related field, or a nursing degree
- At least 3 years of data management and/or related work experience in the pharmaceutical industry
- Working knowledge of clinical research, clinical trial processes, related regulatory requirements, and terminology
- Strong knowledge and experience with several electronic data capture systems, such as Medidata Rave, Oracle InForm, OpenClinica, and Medrio
- Perform duties in compliance with SOPs, GCP, and ICH guidelines
- Ability to prioritize and adapt quickly in fast-paced and changing industry conditions
- Ability to lead a study or data management team independently
- Ability to drive quality and efficiency to meet timelines and milestones and deliver high-quality data management deliverables
- Excellent verbal and written communication skills
- Proficient in Microsoft Office, including Outlook, Word, Excel, and PowerPoint
Benefits
Comp & perks- Professional development and continuous training
- Work-life balance
- Collaborative “one-team” culture
- Equal opportunity and diversity/inclusivity
- Career development opportunities
- Phone interview as the first step of the application process