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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical data management, particularly within the pharmaceutical and biotechnology sectors, with a strong focus on oncology. Proficient in managing cross-functional teams, ensuring compliance with regulatory standards, and delivering high-quality data through effective project management.
Highest-signal resume keywords
Clinical Data ManagementOncology ExperienceProject Management SkillsEDC System KnowledgeSDTM/CDASH Experience
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 DocumentationUser Acceptance TestingData Cleaning ActivitiesECRF DevelopmentStatistical Analysis Plans Review
Soft Skills
Detail-OrientedExcellent Written CommunicationOrganizational SkillsCross-Functional CollaborationMentoring
Tools & Technologies
Medidata RaveMicrosoft Office Applications
Industry Keywords
ICH GuidelinesRegulatory EnvironmentPharmaceutical IndustryBiotechnology IndustryClinical Study Teams
About the role
Key responsibilities & impact- Lead studies within a program
- Oversee data managers and CRO/FSP resources working on assigned studies
- Serve as an active member of Clinical Study Teams
- Collaborate cross-functionally to develop timelines and ensure clinical data management deadlines are met
- Define external data transfer specifications and work with external vendors
- Review and reconcile laboratory data with lab normal ranges
- Develop or oversee development of eCRF and edit check specifications
- Work with database builders on EDC databases, edit checks and reports
- Drive and perform User Acceptance Testing activities for clinical trial database builds and modifications
- Develop or oversee study-specific eCRF Completion Guidelines and Data Management Plans
- Create and maintain data management documentation
- Ensure data cleaning activities comply with Data Validation Specifications and Data Management Plans
- Coordinate with coding groups on clinical study coding
- Define listings for data management, clinical and medical review
- Identify and troubleshoot operational problems using metrics, audit reports and project team input
- Drive data review activities and escalate potential data issues to LDM
- Train personnel on eCRFs and EDC as needed
- Coordinate with Pharmacovigilance on serious adverse event reconciliation
- Review and provide feedback on protocols, Statistical Analysis Plans, CSRs and other documents
- Support process improvement and development and maintenance of SOPs and work instructions
- Collaborate with program leads and other functions to ensure high-quality, on-time data delivery
- Mentor junior Clinical Data Managers as needed
- Perform other duties as assigned
Requirements
What you’ll need- 6+ years of experience in clinical data management in the pharmaceutical/biotechnology industry
- Oncology experience preferred
- Ability to work in cross-functional team-oriented environments
- Understanding of ICH and regulatory environment as it pertains to data management
- Experience with SDTM/CDASH
- Strong project management skills
- Excellent written, verbal and organizational skills
- Must be detail-oriented
- Proficient computer skills, including Microsoft Office applications
- Working knowledge of at least one EDC system; Medidata Rave preferred
- Ability to travel domestically and internationally as required
- Bachelor’s degree or equivalent in a health-related field preferred
Benefits
Comp & perks- Annual bonus plan eligibility for non-commercial roles
- Incentive compensation plan eligibility for commercial roles
- Discretionary equity awards
- Employee Stock Purchase Plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness benefits
- Reasonable accommodation for individuals protected by applicable laws