Clinical Data Manager II

The Clinical Data Manager I (CDM) leads and coordinates Data Management (DM) deliverables 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 II is a member of the Data Management staff.

• Serve as primary contact for DM with all relevant parties both internally (e.g. Project Management, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, external vendors, investigational sites)
• Plan and project the resources required including management of tasks, timelines, risk and quality
• Keep track on budget, forecasts and manage changes of scope requests
• 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
• Develop, review and maintain project-specific DM documents including data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements
• Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks
• Create training materials for EDC users and provide project-specific training as required
• Review and validate clinical data to ensure consistency, accuracy, integrity and completeness
• Create data cleaning plan in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
• 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 reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
• Assist in medical coding tasks as assigned

• Participate in conference calls and/or meetings with vendors and sponsors
• Recognize and solve potential problems and evaluate effectiveness
• Manage the database implementation, lock and close-out processes and procedures
• Maintain documentation on an ongoing basis and ensure that all filing is up to date
• Plan and create necessary documentation to support internal and external audits; participates in such audits assigned
• Help to align data management and clinical programming best practices, standards and conventions within the company

• Actively support staff learning & development within the company
• Develop and deliver applicable DM departmental meetings
• Train and mentor data management
• Participate in the interview process for new recruits
• Proactively track data management development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes

Requirements

• Life science, healthcare and/or related field
• Minimum 3-6 years of relevant work experience
• Minimum 3-6 years of experience in drug development and/or clinical research
• Basic knowledge of ICH-GCP(R2), GDPR/HIPAA and applicable (local) regulatory requirements
• Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation)
• Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models

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