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Data Manager – Inhouse
ClinChoiceData Manager leading data management for clinical trials at ClinChoice. Responsible for high-quality deliverables and team collaboration in a hybrid role.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Data Management activities, including the development of critical documents and adherence to regulatory requirements. Proficient in leading teams and ensuring high-quality deliverables in clinical research settings.
Highest-signal resume keywords
Data ManagementClinical ResearchElectronic Data Capture SystemsRegulatory ComplianceTeam Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data Management PlanData Validation PlanECRF SpecificationsEdit RulesUser Acceptance TestingData ReviewDatabase LockData Transfer SpecificationsSAE ReconciliationMetrics Tracking
Soft Skills
Excellent CommunicationAdaptabilityQuality FocusPrioritization
Tools & Technologies
Medidata RaveOracle InFormOpenClinicaMedrioMicrosoft Office
Industry Keywords
GCPICH GuidelinesSOPsClinical Trial ProcessPharmaceutical Industry
Tech Stack
Tools & technologiesGoogle Cloud PlatformOracle
About the role
Key responsibilities & impact- Lead Data management activities and ensure study deliverables meet timelines and quality standards.
- Review of Clinical research documents (e.g. protocols, Case Report Forms).
- Create and review electronic Case Report Form (eCRF) specifications.
- Develop critical DM documents such as the Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan.
- Develop edit rules/checks, query logic and query messages.
- Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.
- Create and provide training to the clinical team and sites.
- Perform ongoing data review/reconciliation activities and provide metrics and patient trackers to monitor data clean up.
- Perform database lock/unlock and freeze/unfreeze activities as appropriate for statistical review, interim analysis, and final database lock.
- Coordinate the archiving of study databases and related documents.
- Create Data Transfer Specifications and perform external vendor reconciliation.
- Perform SAE reconciliation.
- Work to maintain/improve client satisfaction by ensuring high quality service, communication and management of clinical data.
Requirements
What you’ll need- Bachelor’s degree in clinical/pharmacy biological/mathematical sciences or related field or nursing degree.
- Atleast 3 years data management and/or related work experience in a pharmaceutical industry.
- Working knowledge of Clinical research and clinical trial process and related regulatory requirements and terminology.
- Strong knowledge and experience in 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 to adapt quickly in fast-paced and changing industry conditions.
- Ability to lead a study or data management team independently.
- Proactively drive quality and efficiently to meet timelines and milestones to deliver high-quality data management deliverables.
- Excellent verbal and written communication skills.
- Proficient in the use of Microsoft Office (Outlook, Word, Excel, PowerPoint, etc)
Benefits
Comp & perks- Health insurance
- Professional development opportunities
- Flexible work arrangements
- Paid time off