Senior/Middle Clinical Data Manager

We are seeking a highly skilled and experienced Senior/Middle-level Clinical Data Manager with specialized expertise in the Rave Medidata EDC system to oversee our data management operations. This role requires a proactive professional who can ensure accuracy and integrity in the data collection, processing, and reporting phases of clinical trials. You will play a critical role in the success of our partner trials and contribute to advancements in healthcare.

Key Responsibilities:

• Design, configure, and validate clinical databases in Rave Medidata, including CRF creation, EDC setup, and customized data validation checks.

• Develop and implement data management plans with a strong focus on utilizing the Rave Medidata EDC system to ensure the timely delivery of high-quality data for clinical studies.

• Generate and review data listings, summaries, and reports for inclusion in clinical study reports.

• Perform comprehensive data validation checks within Rave Medidata and enforce stringent quality control measures to guarantee data accuracy and completeness.

• Coordinate with cross-functional teams such as biostatistics, programming, medical writing, and project management to ensure cohesive data management strategies.

• Manage communications related to data management with internal teams and external clients, providing clear and proactive updates.

• Ensure adherence to industry standards and regulatory guidelines.

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Address critical data handling and quality assurance by implementing necessary corrective actions.

Required Knowledge and Skills:

• Bachelor’s degree in life sciences, statistics, computer science, or a related field; Master’s degree preferred.

• At least 3 years of data management experience in a CRO, pharmaceutical, or biotech environment specifically involving Rave Medidata EDC.

• Comprehensive knowledge of clinical trial processes and regulatory standards, including GCP, ICH guidelines, and FDA/EMA regulations.

• Extensive experience with the Rave Medidata EDC system and familiarity with CDISC standards.

• Expertise in industry-standard data analysis and reporting tools, including SQL.

• Advanced skills in data management software and Microsoft Office Suite.

• Proven ability to manage multiple projects simultaneously while maintaining sharp attention to detail and strong problem-solving skills.

• Strong communication and interpersonal skills.

Will Be a Plus:

• Medidata Rave Study Builder Certification.