Senior Clinical Data Manager

CATO SMS is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. CATO SMS is a non-laboratory environment.

We are currently recruiting for two Senior Clinical Data Managers I or II to join our team in the Cary, NC location with the option to work remotely. The Senior Clinical Data Manager I (CDM I) 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 I 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.

Requirements

Qualifications:

• B.S. degree in life science, healthcare and/or related field
• Minimum 5-10 years of relevant work experience
• Minimum 5-10 years of experience in drug development and/or clinical research
• 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

Skills:

• 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
• Experience with electronic data capture (EDC) software systems
• Administrative excellence

Equal Employment Opportunity and Affirmative Action

Cato Research LLC is committed to Equal Employment Opportunity and Affirmative Action. We recruit, hire, train and promote qualified persons in all job titles and ensure that all other personnel actions are administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, marital status, military and/or veteran status, or disability. Furthermore, to the extent required by applicable laws and/or Executive Orders, we take affirmative action to ensure that minority group individuals, females, disabled veterans, recently separated veterans, other protected veterans, Armed Forces service medal veterans, and qualified disabled persons are introduced into our workforce and considered for promotional opportunities. Cato Research, LLC is committed to providing reasonable accommodations to employees and applicants with disabilities to the full extent required by the Americans with Disabilities Act - ADA. If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 919.361.2286.