Job Description
Overview of Role:
We are seeking a highly skilled Senior Clinical Data Management (CDM) Contractor with extensive experience in oncology studies, particularly in late-phase trials and regulatory submissions. This role demands hands-on expertise in optimizing data management processes, ensuring data quality, and facilitating seamless collaboration across teams.
Role and Responsibilities:
· Lead the development and refinement of eCRF forms, specifications, and completion guidelines, ensuring alignment with study protocols and regulatory requirements.
· Proactively devise and implement robust edit checks, query logic, and data query resolution strategies to maintain data integrity and quality.
· Take ownership of Serious Adverse Event (SAE) reconciliation between clinical and pharmacovigilance databases, ensuring meticulous consistency and accuracy.
· Design and execute clinical data standards, data management plans, data transfer agreements, and data flow processes, adhering to industry best practices and regulatory standards.
· Manage vendor relationships and promptly resolve data discrepancies to guarantee the availability of complete datasets for analysis.
· Lead data migration processes and oversee database closeout activities, ensuring seamless transitions and compliance with regulatory guidelines.
· Act as a key representative of Data Management in cross-functional meetings, fostering effective collaboration and alignment on data-centric activities and deliverables.
· Provide continuous support and guidance to project teams, anticipating and resolving data-related challenges to ensure project success.
· Advocate for the standardization of data management practices across teams and studies, promoting efficiency and consistency.
· Respond to ad-hoc data requests from clinical teams, assisting in data cleaning, entry, and exploratory analysis as needed.
· Support data review processes by comparing data against protocols, amendments, and study manuals, ensuring adherence to study requirements.
Experience, Education and Specialized Knowledge and Skills:
· Bachelor’s degree from an accredited institution with a major in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience
· 8+ years of Clinical Data Management experience (oncology experience is required) in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required
· Experience with various data collection and Electronic Data Capture (EDC) systems and understanding of the MedDRA and WHODRUG coding processes
· Excellent interpersonal, communication, and leadership skills
· Consistent, detail oriented, communicative, dedicated to do a job well done
· CRO and vendor oversight experience preferred
· Strong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
Company Description
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