Clinical Data Manager I

The Clinical Data Manager I (CDM I) supports Data Management (DM) activities from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.

The CDM I works on studies with appropriate supervision from a CDM II or Senior CDM.

The CDM I is a member of the Data Management staff.

• Participate in the review of study documents (e.g. protocol, (electronic) case report forms (eCRFs), safety plans/manuals and statistical analysis plan).
• Provide support on clinical study database set-up, including eCRF design and database validation requirements.
• Provide support in developing, reviewing and maintaining project-specific DM documents including data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements.
• Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks.
• Support creating training materials for EDC users and provide project-specific training as required.
• Support in reviewing and validating clinical data to ensure consistency, accuracy, integrity and completeness.
• Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance etc.
• Perform and/or coordinate various data transfers and data reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data.
• Assist in medical coding tasks as assigned.
• Assist in training of other DM personnel and project teams.
• Help to align data management and clinical programming best practices, standards and conventions within the company.
• Explore and propose initiatives for improving efficiency.
• Participate in internal and external audits.
• Maintain documentation on an ongoing basis and ensure that all filing is up to date.
• Assist in managing the database implementation, lock and close-out processes and procedures.
• Recognize and solve potential problems and evaluate effectiveness.
• Participate in conference calls and/or meetings with vendors and sponsors.

Requirements

Qualifications

• Life science, healthcare and/or related field degree
• Minimum 2-4 years of relevant work experience
• Minimum 2-4 years of experience in drug development and/or clinical research
• Basic knowledge of ICH-GCP(R2), GDPR/HIPAA and applicable (local) regulatory requirements
• Good understanding of CDISC data conventions
• Good understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation)
• Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required
• Strong written and verbal communication skills including good command of English language
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Administrative excellence

• Eye for detail, strong technical, analytical and problem-solving skills
• Strong project management skills
• Ability to translate guidelines, rules and regulations in clear and usable recommendations