Clinical Data Programming Manager in Marlborough, MA at Integrated Resources, Inc

Date Posted: 6/26/2020

Job Snapshot

Job Description

Perform the clinical data programming activities for trials from end to end (i.e. Study database build to SDTM and e-sub deliverables).
Provide technical support for standardization/process initiatives.
Acquire/develop/maintain/share/explore/implement global clinical trials practices, methodologies, procedures, industry standards, regulatory requirements and recommendations.
Essential Functions
• Manage clinical data programming tasks for multiple studies.
• Provide programming support for study team members from the study start up to the end.
• Review/generate specifications for the database, data transfer, SDTM mapping specs to ensure that documents and specification are consistent and comply with internal/industry standards.
• Perform data reconciliation, data quality control, and program SAS edit checks.
• Generate all necessary outputs (table, listing, figures) for ongoing data review meetings and RBM using SAS and Spotfire.
• Review/generate/validate electronic submission deliverables such as SDTM datasets, Define.XML, aCRF, Reviewers Guide.
• Perform Quality Testing/User Acceptance Testing of EDC systems.
• Provide adhoc listing, reports and graphs to various teams on request from the ongoing and legacy studies.
• Support quality control and quality audit of deliverables.
• Contribute to activities in validation and implementation including standard reporting systems, SAS macro utility programs and associated tools.
Minimum education requirements
Experience required 5 - 7 Years

Knowledge & skills (general and technical)
• Minimum of 5 years' of hands on SAS programming experience in a pharmaceutical environment.
• Strong understanding of clinical trial data.
• Strong understanding of relational database components and theory.
• Strong understanding of SAS Programming.
• Experience with SAS Drug Development.
• Experience with Pinnacle 21 Enterprise to validate and design studies.
• Experience with Medidata Rave.
• Experience with Sportfire.
• Experience with Python and/or R highly desired but not required.
• Strong knowledge of regulatory requirements and guidance (e.g. GCP, ICH).
• Strong knowledge of industry standards with at least 5 years of hands on experiences (e.g. CDISC SDTM, ADaM, ODM, Define.XML).

Other requirements (licenses, certifications, specialized training, physical or mental abilities required)
Must have excellent oral and written communication skills.

Confidential Data
All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best " industry practices and the highest ethical standards.