Manager Clinical Data Programming
Req ID: 4319BR
Position title: Manager Clinical Data Programming
Location US- Marlborough, MA
Job type Full-time
Summary of Responsibilities Design the database, clean the data, standardize the data, provide ad-hoc listings and reports for clinical trials. Also responsible for creation of the SDTM datasets and define file for submission. Provide technical support to data managers for all aspects of data management activities.
Essential Functions - Provide technical support for data managers from the study start up to the end.
- Develop and provide listings for SAE reconciliation.
- Participate in the programming review of Case Report Forms (CRFs), annotated CRFs, database structures and study related documentation (e.g. edit check specifications).
- Develop and review SAS programs and output as required for the management of clinical trial data, creation of SDTM datasets and define, preparation of patient data listings, graphical output, and tables for Ongoing Data Review Meeting
- Develop SAS programs for ad hoc tables and listings. Write, modify, and maintain programs that produce outputs for data review in support of Data Management.
- Perform electronic data transfer (both incoming and outgoing).
- Develop and review specifications/programs to ensure the data transfer has been produced to specification.
- Perform third vendor data reconciliation with the database extracts.
- Generate/Validate SDTM related materials such as aCRF, specifications, datasets, define.xml
- Perform Quality Testing and/or User Acceptance Testing of EDC systems prior to start of the study.
- Provide adhoc listings, reports, and graphs to various teams on request from the ongoing and legacy studies
- Develop and implement edit checks for the final databases before the database lock.
- Assist the global standards team in standardizing the database design and CRF.
Minimum education requirements Bachelors Experience required 3 - 5 Years Knowledge & skills (general and technical) Minimum of 3 years’ of hands on SAS programming and CDISC SDTM experience in a pharmaceutical environment
Understanding of clinical trial data
Understanding of relational database components and theory
Understanding of SAS Programming
Experience with SAS Drug Development is preferred
Experience with J-Review or I-Review is preferred
Experience with SAP BOXI is preferred
Experience with Rave is preferred
Understanding of regulatory requirements and guidances (e.g. GCP, ICH)
Understanding of industry standards (e.g. CDISC SDTM, ADaM, ODM, Define.XML)
Must have excellent oral and written communication skills.
Confidential Data All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance 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.
Mental/Physical Requirements Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.