Senior Clinical Data Manager
The Clinical Data Manager will provide subject matter expertise of data management for sponsor oversight of phase 1 to phase 3 clinical trials. He/she will be responsible for all aspects of data management from the creation and implementation of database systems, the collection and cleaning of study data, database lock, data analysis through the submission of clinical data. Throughout each aspect, the Clinical Data Manager will ensure the completeness, accuracy and consistency of data and data management processes to ensure that clinical data meets the applicable US Code of Federal Regulations (CFR), the International Council on Harmonization – Good Clinical Practice (ICH-GCP) and EU Directive quality standards required for reporting to regulatory bodies.
Essential Duties and Responsibilities
- Lead and conduct all data management activities required for Sanaria’s portfolio of clinical trials; serve Sanaria’s internal data management expert.
- Work alongside collaborators and data management vendors to oversee the setup, conduct and final review of all data management operations.
- Contribute to the review and development of clinical protocols, statistical analysis plans (SAPs), Data Management Plans (DMPs), Data Validation Plans (DVPs) and any other associated study documents as required to generate study database design specifications including CRF/eCRF design, edit checks, system notifications, query logic, user role setup, randomization and medical coding.
- Generate and/or review study database design specifications including CRF/eCRF design, edit checks, system notifications, query logic, user role setup, randomization and medical coding.
- Ensure CDISC’s Clinical Data Acquisition Standards Harmonization (CDASH) standards are adequately implemented into the eCRF / study database.
- Facilitate MedDRA and WHO Drug Dictionary coding reconciliation between the data management company, site and sponsor medical officers.
- Ensure quality assurance and quality control measures are implemented throughout all data management aspects.
Review data at critical time points, assess the quality of the statistical programming process; review, or as needed, generate reports, figures, tables and listings.
- Oversee and ensure proper installation, validation and change control activities are in place and verify adequate system testing and adequate quality control measures are instituted for all clinical trial databases, and as required other clinical trial software, such as eTMF and/or other Software as a Service (SAS) software used within in Sanaria. As required:
- Perform database validation
- Develop User Acceptance Testing (UAT) scripts
- Lead and or perform UAT on clinical trial databases, trial master file (TMF) software, and any other in-house SaaS as needed
- Ensure study databases and SaaS software is implemented in accordance with programming standards and validation procedures
- Track change control and work with data management vendor to ensure accurate system release records
- Lead and/or assist in the integration of external systems and data, such as sample management information from Freezerworks, external laboratory data from hematology and biochemistry machines, etc., into the clinical trial database, as required. This may be later expanded to additional systems such as quality controlled document software, interactive randomization software, etc.
- Develop, review and maintain data management documentation. This includes standard operating procedures (SOPs), Data Management Plans, Data Validation Plans and another data management documents required per the Drug Information Association (DIA) Trial Master File(TMF) Reference Model; this may also include clinical trials data management best practice guidelines as applicable.
- Ensure Data Management and Data Validation Plans are maintained up-to-date, meet all ICH-GCP and US CFR requirements and are adequately implemented throughout each study’s lifecycle.
- Ensure all appropriate database and statistical data documentation from database start-up activities through database lock and final statistical analysis are created or obtained, and that they are adequately maintained. Upload database and statistical analysis documents into Sanaria’s electronic Trial Master File (eTMF) system, Veeva Vault eTMF.
- Perform data monitoring functions as necessary:
- Become trained for all used data management systems.
- Liaise with the contracted database company for database related issues identified by the site.
- Assure the integrity of all clinical data.
- Conduct centralized monitoring; ensure proper data collection and discrepancy management.
- Issue queries, investigate data inconsistencies and ensure all data queries / anomalies (originating from the data management company, clinical monitor of self-generated) are reconciled in a timely fashion.
- Ensure protocol deviations are adequately captured in the database and reported as required.
- Identify and communicate GCP violations in the database structure, function and use such as faulty audit trails, time stamps, edit checks, user identifications or access controls as related to 21 CFR part 11 compliance, Good Clinical Data Management Practices (GCDMP), ICH-GCP and any other applicable local or national regulations.
- Lead and/or assist in clinical database training both internally and externally; externally may include remote and as necessary, on-site database training.
- Participate in regular Sponsor/Site teleconferences.
- Act as the sponsor liaison between the data management vendor, the clinical monitor(s) and the clinical trial site in regards to the clinical trial database.
- As required, support on-site clinical teams and clinical monitors in regards to data management, query resolution and compliance with the protocol and applicable regulations/ GCDMP, data accuracy and data quality.
- Manage the conversion of legacy data to acceptable formats including STDM and ADaM by working with vendors and ensuring all necessary specifications for regulatory electronic submission are met.
- Work with the Clinical Research Manager to oversee data management vendors and ensure deliverables are adequately and provided according to the required timelines.
- Ensure monitoring function capabilities are adequate in the database; work with external clinical monitors to address any database system monitoring issues.
- Contribute to the development of Risk Management Plans.
- Conduct risk assessment relating to database management, electronic data capture (EDC) system and data analysis.
- Ensure adherence to GCDMP both internally and externally.
Additional Duties and Responsibilities
- Participate in departmental and cross-departmental meetings to review progress of ongoing clinical trials.
- Assist in the creation and review of progress and safety reports as needed to ensure the accuracy, scientific excellence, and congruence of message between studies in a project.
- Aid in the establishment of a data warehouse for the integration of all Sanaria clinical trial data.
- Perform a global review of data across different trials; investigate inconsistencies within and across individual databases and reconcile any inconsistent findings.
- Support selection and implementation of a pharmacovigilance / safety database.
Assist in internal and external audits as needed.
- Review other trial or Clinical Department related documents as necessary.
- Extract raw data and data sets from previously completed clinical trials from various EDC systems, including OpenClinica.<
- Assist in the creation and review of clinical study reports.
- Prepare and implement site-specific training as necessary.
- Maintain project timelines.
- Perform other reasonable duties assigned by management.
- Understanding of Sanaria’s mission, objectives and values
- Subject matter expertise on clinical data management processes and systems
- Knowledge of study conduct and drug/biologic development process for Phase 1-3 clinical trials conducted under US Investigational New Drug Applications (INDs), from pre-initiation through study closure and final data analysis.
- Knowledge of ICH-GCP guidelines, US Code of Federal Regulations, and US FDA guidance documents.
- Knowledge of GDP and version control.
- Experience implementing and assuring relevant regulatory requirements are met, such as US CFR 21 Part 11, CDISC’s Clinical Data Acquisition Standards Harmonization (CDASH) and reporting of adverse event summary information for registered trials per 42 CFR Part 11.
Education, Work Experience and/or Licensure
- Required: BA/BS (Masters preferred) in a health, science or computer science related field
- Required: 5-7 years of experience working with clinical data management systems as the data manager level or higher
- Required: GCP certification
- Required: Excellent oral and written communication skills
- Ability to adapt to changing needs of the program
- Leadership and project management abilities
- Strong organizational skills
- Team-player, adaptable to a dynamic environment
- Mission focus
- High professional standards
- Flexible thinking in response to complex data, ambiguity and criticism
- Ability to identify innovative pathways to achieve objectives
- Solid judgment, reasoning and planning
- Good listening skills, patience, and composure
- Previous involvement with database warehouse set-up and maintenance
- Ability to extract and create reports with SAS databases
- Experience with supervision of data management and data entry personnel
- Experience extracting data from various databases, notably OpenClinica