Senior Clinical Data Manager

1 month ago


Akron, Ohio, United States TechData Service Company LLC Full time
Job Overview

As a Senior Clinical Data Manager at TechData Service Company LLC, you will play a pivotal role in ensuring the integrity and quality of clinical data. This position requires a strong understanding of clinical research, regulatory requirements, and data management best practices.

Key Responsibilities

• Develop and refine eCRF forms, specifications, and completion guidelines to align with study protocols and regulatory requirements.

• Design and implement robust edit checks, query logic, and data query resolution strategies to maintain data integrity and quality.

• Oversee Serious Adverse Event (SAE) reconciliation between clinical and pharmacovigilance databases, ensuring meticulous consistency and accuracy.

• Manage vendor relationships and 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.

• Collaborate with cross-functional teams to foster effective 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.

Requirements

• 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 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, and dedicated to doing 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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