Notes : Candidate needs to be an individual or an independent contributor. Candidates from a complete CRO and FSP background are eligible.
The Senior Clinical Data Manager (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. This position also serves to contribute to process improvements, staff learning & development and provides input for DM services cost proposal. The Senior CDM is a member of the Data Management staff.
Responsibilities:
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) on a regular basis throughout the study
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 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.
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 reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data.
Perform Medical Dictionary for Regulatory Activities (MedDRA) and/or World Health Organization Drug Dictionary (WHO-DD) medical coding procedures
Participate in conference calls and/or meetings with vendors and sponsors.
Keep track on project timelines and manage changes of scope, budgets and resourcing needs.
Keep oversight on relevant Data Management activities within a project, as specified in the Data Management Plan
Manage the database implementation, lock and close-out processes and procedures.
Organize and distribute study data to facilitate statistical analysis and reporting.
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
Provide leadership, guidance and support to other department members.
Qualifications:
B.S. degree in life science, healthcare and/or related field
Basic knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (local) regulatory requirements
Experience with tools and systems for managing clinical studies.
Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation)
Experience in CDISC conventions, i.e., CDASH, SDTM model and hands on experience implementing these models.
Eye for detail, strong technical, analytical and problem-solving skills
Ability to simplify complex issues into understandable concepts.