Job Description

Job Description

Job Description

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

· 7+ years of Clinical Data Management experience (oncology experience is preferred) 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

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