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.

• 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.
• Programming experience in SAS, JavaScript, or Python.

Companies on the stop list:
Intego, Covance, CS Ltd / Veranex Labcorp, Clintec is an IQVIA

The steps in the hiring process:

1. General Interview.
2. Technical Interview(Manager of SAAS department, DM)
3. Interview with VP Engineer.

Team:
20 specialists, including 15 SAAS engineers, Head, Compliance Manager, DM, and department manager.

Additional information:
Working on the specific American project.