layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Senior Clinical Data Manager at Tango Therapeutics | LAYIQ

Bachelor's degree in Computer Science, Life Sciences, Mathematics, Health Sciences, or related field
5+ years of Clinical Data Management experience within the biotechnology, pharmaceutical, or CRO industry
Experience leading Data Management activities for clinical trials in a regulated environment
Experience managing outsourced Data Management activities and providing vendor oversight
Experience managing clinical systems (incl. IRT/ eCOA) configurations and implementations, enhancements, integrations, and technology vendors; Experience leading User Acceptance Testing (UAT)
Experience supporting database build, data cleaning, external data integrations, medical coding, database lock, and submission readiness activities
Experience working within global clinical development organizations
Experience supporting audits, inspections, and inspection-readiness activities preferred
Experience using electronic data capture (EDC) platforms and clinical data technologies
Oncology clinical development experience preferred
Strong knowledge of Clinical Data Management processes and the clinical trial data lifecycle
Strong knowledge of ICH-GCP, FDA regulations, EU Clinical Trial Regulation (CTR), data integrity principles, and other applicable regulatory requirements
Knowledge of CDISC standards, including CDASH and SDTM, and associated clinical data requirements
Proficiency with EDC systems, IRT, eCOA, and related clinical technologies
Knowledge of medical coding dictionaries, including MedDRA and WHODrug
Familiarity with data visualization, analytics, and reporting tools
Strong understanding of risk-based quality management and critical-to-quality (CtQ) principles
Strong vendor management and sponsor oversight capabilities
Strong project management, organizational, and prioritization skills
Excellent collaboration skills with cross-functional stakeholders, including Biostatistics, Statistical Programming, Pharmacovigilance, Clinical Operations, and Regulatory Affairs
Strong analytical thinking, problem-solving, and decision-making capabilities
Excellent written and verbal communication skills
We are an equal opportunity employer and value diversity at our company.
We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Senior Clinical Data Manager

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