senior associate - CDISC
Creative Solutions Services LLC - Cambridge, MA

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We?re looking for a contractor with technical experience managing clinical data using the CDISC SDTM standard to fulfill the role of the CIDR Metadata Analyst. The CIDR Metadata Analyst works with internal and offshore teams to load clinical data into the Clinical Integrated Data Repository (CIDR).

This role focuses on the application of study specific metadata for the loading of clinical data into, and creation of analysis schemas out of, CIDR.

It is expected that the candidate will have had experience as either a Clinical Programmer or Statistical Programmer working on studies in support of a regulatory submission. This role will require extensive experience with the SDTM model, specifically reviewing and mapping clinical data to ensure SDTM compliance.

The candidate will be expected to have strong communications skills, as she/he will work with the Senior Metadata Analyst to direct and QC the work of the CIDR offshore team. Ideally the candidate will have experience working with, directing or leading an onshore or offshore team. This role also works with other roles in the organization focused on clinical data standards and metadata operations to promote efficiency in the loading and exchange of data throughout the Biogen Idec enterprise.

Works with the Senior Metadata Analyst & CIDR offshore team on the population of CIDR with clinical data. Includes:
? Directs and completes clinical source data assessments in preparation for loading into CIDR.
? Reviews study specific load requests and study or program analysis extract requests for consistency and quality.
? Assists with derivation of operational metrics for reporting.
? Completes quality control activities to ensure data integrity.

? (Must Have) Minimum of 5 -8 years of clinical data management, and programming or statistical programming experience working in the biotechnology or pharmaceutical industry; preferably with global experience; work with CROs highly desirable.
? (MH) Education: BS/BA or equivalent in a discipline related to Clinical Data Management Systems.
? (MH) Demonstrated experience with CDISC SDTM standards and manipulating data into standard format required.
? (MH) Metadata Management and SQL or SAS experience required, with demonstrated database and programming language experience.
? (MH) Technical/Software Skills: Experience with Oracle Clinical or other clinical data management software; familiarity with medical coding dictionaries, especially MedDRA and WHO. General software skills: Outlook, MS Access, MS Word, MS Excel, MS Project, Visio, Business Objects, SQL, SAS.
? (Nice To Have) Aware of current global regulatory guidelines relevant to Clinical Data Management, as well as related Pharma Development SOPs, guidelines and Best Practices In-depth knowledge and understanding of the drug development process and data management process.
? (NTH) Knowledge of GCP and other regulations.

Soft Skills
? (MH) Excellent oral and written communication skills.
? (MH) Ability to manage multiple projects and processes simultaneously.
? (MH) The candidate should be detail oriented, identify issues and assist in problem solving in a timely manner.
? (MH) Ability to handle multiple (changing) priorities under tight timelines.
? (NTH) Proven ability to build relationships and manage expectations with key data management service providers who represent single or multiple functions.
? (NTH) Internal customer management, team effectiveness and enhancement, timeline management, proactive problem solving ability.
? (NTH) Ability to work well in a fast-paced environment.

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