Sr. Clinical Data Manager

1 week ago


Menlo Park, United States TechData Service Company LLC Full time
Job DescriptionJob 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 Descriptionwww.techdataservice.comCompany Descriptionwww.techdataservice.com

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