Clinical Data Scientist and Manager
Sanaria, an innovative Rockville, MD biotechnology company working on novel malaria vaccines, has an opening for an experienced Clinical Data Scientist and Manager.
The Clinical Data Scientist and Manager (CDSM) will have two main functions:
1. Sanaria has completed or will soon complete more than 20 clinical trials of its PfSPZ vaccine candidates. The CDSM will be responsible for systematically depositing de-identified data on all subjects from these clinical trials into an NIAID repository such as IMMPORT or some other public repository that is designated as FAIR (findable, accessible, interoperable and reusable). In addition, the CDSM will perform a meta-analysis of the data to look for associations between key independent variables such as history of malaria exposure or age and the immune responses to vaccination, and will plan to publish this meta-analysis.
2. Provide subject matter expertise of data management for sponsor oversight of ongoing and future Phase 1 to Phase 3 clinical trials. The CDSM 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. The resulting data sets will be then be deposited into the public repository as described above.
Essential Duties and Responsibilities:
Data Management Duties and Responsibilities
1. For data deposition function on previous clinical trials
- Acquire all databases
- Appropriately structure databases
- Deposit databases
- Conduct meta-analysis of databases
2. For data management for sponsor oversight for ongoing and future clinical trials
- 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.
- 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.
- Perform data monitoring functions as necessary.
- 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 regarding the clinical trial database. As required, support on-site clinical teams and clinical monitors for 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.
- Knowledge and Abilities (required):
- Understanding of Sanaria’s mission, objectives and values
- Subject matter expertise on clinical data management processes and systems including the use of SAS or similar statistical programming languages.
- 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: 2 years of experience working with clinical data management systems at the data manager level or higher
- Required: GCP certification
- Language Skills
- Required: Excellent oral and written communication skills
- Additional Skills
- Ability to adapt to changing needs of the program
- Leadership and project management abilities
- Team-player, adaptable to a dynamic environment
- Mission focus
- High professional standards and attention to detail
- 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
- Experience 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
To apply, send cover letter with salary requirement and resume to firstname.lastname@example.org, subject line “Clinical Data Scientist.” Candidates must have long-term eligibility to work in the US without sponsorship. Sanaria is an equal opportunity employer. For more information, see our website, www.sanaria.com.