Description:
Manages Data Systems to ensure the timely creation, deployment and maintenance of databases required by companies projects. Analyzes study protocol and project requirement(s), identifies data quality rules, and design data entry interfaces in accordance with DMP, SOP, client requirements, and regulatory guidelines.
Provides technical support for the Data Systems employed in processing and management of study data encompassing reporting tools for data review and DM metrics, performance and quality, generation
Resolves data integrity issues and addresses database design inconsistencies over time.
Manages and monitors interactions with project specific third party vendors.
Identifies process optimization to improve efficiencies. Develops and maintains standard library (global, therapeutic and client specific).
Provides technical support to the Global Data Management (GDM) staff and Project Team for existing databases, user interface, reporting tools, metrics generation andCDISC standards.
Responsibilities:
- Deploy complete, accurate and efficient database(s) for the purpose of Data Management and Data Processing. To conduct and support design and programming of data entry interface, data structures and quality rules for assigned projects and studies.
- Support and ensure the preparation, transfer and integration of clinical data from internal and external sources into the study database.
- Provide data in various formats and applications to data management customers.
- Ensure high quality deliverables, good cooperation with internal and client partners and active participation in project teams.
- Setup of Data Management tools for study conduct. (e.g., data quality checks, validity tool, coding call, SAE, etc.)
- Full study programming and validation responsibility - Develop, program, test and maintain computer edit/validation checks.
- Develop programs for transformation of the acquisition of data from the ‘core’ Data Systems to a definitive study database to meet companies/ client project standards.
- Ensure in conjunction with Data Project Manager adherence to companies standards and validation of all study related calculations and data mappings.
- Full responsibility for data exchange with external parties, for example, client, third party vendors (Labs, ECG, etc.) and Safety / Independent Data Monitoring Committees.
- Provide ongoing day to day end-user support to the GDM team to ensure all systems and programs are executing correct and efficiently.
- Setup and support of data review and reporting tools required by DM stakeholders in GDM, Clinical, Medical, Pharmacovigilance and Regulatory Affairs and where required Client Study Management Team.
- Provide technical expertise and programming support for companies projects and data management staff.
- Communicate project status and key project issues to DPM.
- Assist in developing new Data Systems programming procedures and processes.
- Keeps current with technological advances and coordinates activities with Global Training and Information Technology Team in an effort to maximize their potential use in managing data.
- Provide mentoring and training of others.
- Assist in delegating work.
- Run and review department metrics, plus perform some root cause analysis.
- Manages Data Systems and support projects at company with special attention to the administration and evaluation of Data Systems including but not limited to CDMS, EDC, Safety, Clinical and Regulatory Systems, ensuring that all submission data are captured and stored in a validated environment consistent with 21 CFR part 11.
- Supports, maintains and utilizes standardization of CRF and eCRF modules, data quality rules, data structures, data libraries, code lists, and dictionaries in conjunction with input from other functional areas and project teams and in accordance with CDISC standards.
- Provides technical expertise to project teams in the operational aspects of Data Systems and support, ensuring consistency among systems to avoid redundancy, inefficiency, or potential problems; and keeps current with technology trends as they affect data systems management.
- Manages and coordinates activities of EDC vendors through the project cycle of all EDC studies from study start up to archival ensuring adherence to companies procedures and policies.
- Provides training in use of systems, including but not limited to Oracle / Clinical and EDC, as well as, the application and use of CRF and eCRF modules, data quality rules, data structures, data libraries, code lists, and dictionaries to other functional areas and project teams.
- Manages and coordinates external vendors’ activities ensuring their adherence to contract specifications.
- Manages and coordinates the integration / consolidation and archival of databases in accordance with applicable company, client and / or regulatory guidelines.
- Evaluates external vendors and technologies as to their ability to perform in accordance to companies goals, procedures, and quality standards prior to contract finalization.
- Identifies areas of process improvement that may be provided by standardization and/or technology to increase efficiency, quality and timeliness of data management processes and deliverables.
- Provides metric reports for monitoring the progress of projects and processes for reporting to management and project teams.
Working Relationships:
- Reports to Manager, Data Systems
- Collaborates with all departments
- Liaise with sponsors
- Liaises with external vendors
Qualifications:
- BA/BS in a life or computer science, Master’s Degree in Science/Biological or computer science preferred or a combination of education and experience
- 5 to 8 years pharmaceutical/Data Management
- Excellent oral and written communication skills
- Proficient in the use of computer software systems (Word, Excel, PowerPoint, Microsoft Project, Share Point, CTMS, timesheet software, etc.)
- Excellent problem solving, analytical, organization and time management skills
- Customer focus, flexibility
- Good project management skills
- SAS programming experience preferred
- Strong experience in using data management technologies (clinical data management systems, electronic data capture, data review tools, data warehousing)
- Expert in clinical databases, CDMS such as Clintrial or Oracle Clinical, SAS, SQL+
- Expert in EDC system(s) such as Merge, DataTrak, Datatrial, Phase Forward, Rave
- Experience in developing data management standards
- Ability to apply 21 CFR Part 11 standards to Data System deployment
- Experience managing vendors
- Demonstrate knowledge in research design, system validation, CDISC, standard coding dictionaries