Company: Pharm-Olam International
Reference: Data Programmer_SS_ India _23/11
Closing Date: 21 Jan 17
Type: Full Time
Salary (£): Competitive
Summary: Supports Data Systems personnel to ensure the timely creation, deployment and maintenance of databases required by Pharm-Olam projects. 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.
To support design and programming of data entry interface, data structures and quality rules for assigned projects and studies. Setup of Data System for study conducts (e.g. data quality checks, validity tool, coding call, SAE etc.)
Provide data in v
Assists Data Systems personnel with resolving data integrity issues and addressing database design inconsistencies over time.
Provides technical support to the Global Data Division (GDD) staff and Project Team for existing databases, user interface, reporting tools, metrics generation and CDISC standards.
Identifies process optimization to improve efficiencies. Assists Data Systems personnel with development and maintenance of standard library (global, therapeutic and client specific).
arious formats and applications to data management customers, per Pharm-Olam/client specifications.
Support of data review and reporting tools required by DM stakeholders in GDD, Clinical, Medical,zPharmacovigilance and Regulatory Affairs and where required Client Study Management Team.
May provide 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.
Ensure in conjunction with DPM adherence to Pharm-Olam standards and validation of all study related features (calculations, data mappings, etc).
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.
Performs the integration / consolidation and archival of databases in accordance with applicable Pharm-Olam, client and / or regulatory guidelines. Support and ensure the preparation, transfer and integration of clinical data from internal and external sources into the study database.
Supports studies with User Administration tasks.
Ensures that all submission data are captured and stored in a validated environment consistent with 21 CFR part 11
Education Requirements and Qualifications:
BS degree in a biological science, Statistics, Computer Science or a related field and/ or combination of education/experience preferred
2-3 years’ experience in pharmaceutical/CRO building clinical databases preferred
Good understanding of the drug development process
Very good understanding of data handling processes and preferable clinical data programming
Experience in SAS programming and/or using EDC technologies (e.g. clinical data management systems, electronic data capture, data review tools, data warehousing)
Good understanding of regulations, standards and guidelines (e.g. ICH, GCP, CDISC, European Clinical Trials Directive, Privacy rules [HIPPA])
Good oral and written communication skills
Proficient in the use of computer software systems (Word, Excel, PowerPoint, Microsoft Project, Share Point, CTMS, timesheet software, etc.)
Good problem solving, analytical, organization and time management skills
Customer focus, flexibility
The Brackens, London Road, Ascot, Berkshire
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