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Lead Clinical Data Manager
Iambic Therapeutics. Serve as the primary Data Management resource on one or more clinical studies from study start-up through database lock and close-out .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical data management, including database setup, data cleaning, and compliance with ICH-GCP and FDA regulations. Proficient in managing vendor performance and leading cross-functional teams to ensure high-quality deliverables.
Highest-signal resume keywords
Clinical Data ManagementEDC Systems ManagementFDA Regulations KnowledgeOncology ExperienceCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Database SetupData CleaningQuery ManagementData Standards ApplicationMedical Coding GuidelinesData Review PlansSASExcelSpotfirePython
Soft Skills
Excellent CommunicationOrganizational SkillsLeadershipMentoringCollaboration
Tools & Technologies
Medidata RaveEDC Systems
Industry Keywords
ICH-GCPGood Clinical PracticeHIPAARECISTRANOPhase III StudiesCRO ManagementData Management PlansSOPsWork Instructions
Tech Stack
Tools & technologiesPython
About the role
Key responsibilities & impact- Serve as the primary Data Management resource on one or more clinical studies from study start-up through database lock and close-out
- Coordinate Data Management activities with sponsors, CROs, and cross-functional teams
- Manage database setup and design, Database UAT, query management, data cleaning, and third-party data reconciliation
- Author and maintain Data Management Plans, Data Review Plans, CRF completion guidelines, data review guidelines, medical coding guidelines, and data transfer agreements
- Oversee CRO and EDC vendor performance and deliverables
- Assist with vendor selection, risk assessment, timeline and resource planning, and issue escalation
- Represent Data Management on project teams, working groups, investigator meetings, and sponsor or health authority inspections and audits
- Ensure application of data standards and CDISC conventions, including CDASH and SDTM
- Contribute to process improvement initiatives, SOPs, and Work Instructions
- Ensure compliance with SOPs, Work Instructions, ICH-GCP, and applicable regulations
- Lead, mentor, and drive high-quality, on-time deliverables
Requirements
What you’ll need- BA/BS degree in a scientific discipline, nursing, business, or information systems
- 7–10+ years of clinical data management experience, including sponsor and/or CRO-side experience
- Advanced knowledge of EDC systems; Medidata Rave preferred
- Demonstrated experience overseeing CRO and EDC vendor performance and deliverables
- Strong knowledge of FDA regulations, ICH guidelines, Good Clinical Practice, and HIPAA
- Oncology experience and knowledge of RECIST/RANO response criteria
- Excellent communication, organizational, and cross-functional collaboration skills
- Ability to travel approximately 10%, or as needed for business-critical activities
- Experience supporting health authority inspections or audits preferred
- Experience with Phase III pivotal studies preferred
- Working knowledge of SAS or other programming/reporting tools such as Excel, Spotfire, or Python preferred
Benefits
Comp & perks- Company paid healthcare
- Flexible spending accounts
- Voluntary life insurance
- 401K matching
- Uncapped vacation
- Onsite gym
- Dining at the facility