Associate Director, Clinical Data Management
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Experteer Overview In this role you will lead and oversee Clinical Data Management (CDM) activities for multiple clinical studies, ensuring timely, accurate data capture and processing. You will partner with cross-functional teams and external vendors to drive data quality and study success within a fast-paced oncology environment. You will define data management strategy, manage timelines, and mentor the internal team while ensuring regulatory compliance. This is an opportunity to shape how data supports pivotal trials in a mission-driven company advancing RAS-targeted therapies. Compensation / Benefits * Define and execute data management strategy at project level * Oversee external data vendors and CROs; manage relationships and deliverables * Ensure data accuracy, consistency and completeness; handle SAE reconciliation, data reconciliation, coding, deviations, and query resolution * Lead CDM oversight of outsourced/partner trials; scope, project manage, review deliverables * Plan and coordinate CDM tasks across clinical studies; manage timelines * Review CRO proposals; act as liaison with EDC vendors and data suppliers * Review CRFs and CRF completion guidelines; lead data listings, table validation, and data transfer specs * Ensure Data Management Plans are followed; standardize data models across projects * Mentor and manage internal CDM team; lead SOP development and department initiatives * Handle data issues, vendor documentation, reconciliation; support audits and regulatory reviews Tasks * 11+ years of experience designing and running early/late-stage clinical trials * MS, BS/BA degree or equivalent relevance * Experience with clinical databases, medical terminology, coding dictionaries, quality control and auditing * Strong knowledge of ICH, FDA and GCP regulations * Proven leadership and teamwork; ability to thrive in a collaborative, high-energy environment * Excellent written and verbal communication; ability to multitask and prioritize in interdisciplinary teams * Industry experience essential Key requirements * competitive compensation * equity awards * strong benefits * learning and development opportunities
Requirements
and coordinate CDM tasks across clinical studies; manage timelines * Review CRO proposals; act as liaison with EDC vendors and data suppliers * Review CRFs and CRF completion guidelines; lead data listings, table validation, and data transfer specs * Ensure Data Management Plans are followed; standardize data models across projects * Mentor and manage internal CDM team; lead SOP development and department initiatives * Handle data issues, vendor documentation, reconciliation; support audits and regulatory reviews Tasks * 11+ years of experience designing and running early/late-stage clinical trials * MS, BS/BA degree or equivalent relevance * Experience with clinical databases, medical terminology, coding dictionaries, quality control and auditing * Strong knowledge of ICH, FDA and GCP regulations * Proven leadership and teamwork; ability to thrive in a collaborative, high-energy environment * Excellent written and verbal communication; ability to multitask and prioritize in aaaaaaaaaaa 94064, teams * Industry experience essential Key requirements * competitive compensation * equity awards * strong benefits * learning and development opportunities
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