job title:associate clinical data programmaer(clario)

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Attend client meetings as appropriate to understand data collection requirements. Review standard CLARIO and non-standard data specifications and interact with the Data Manager (DM) to finalize specifications. Develop programs to create Clario standard and non-standard data files. Participate in the validation of encoding programs which generates CLARIO standard and non-standard data files. Process data extracts, review encoding requests daily to run encoding programs and participate in study archival. Performing ad-hoc programming activities utilizing raw data based on internal and external requests for:

a. Esoteric quality control checks requested by QC.

b. Data resolution/Mining.

c. Other client requirements.

Get exposed to 5 modalities. Review User Requirements and create and/or review Functional and Technical Specifications. Work with data management in providing programming support for DM activities including data review.

OTHER DUTIES AND RESPONSIBILITIES:

Assist with orientation and training of personnel as determined by management. Contribute to process development. Review and development of SOPs and associated documents related to Clinical Data Programming activities. Complete administrative tasks as needed within Clinical Data Programming.

The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. The Company reserves the right to amend or change this job description to meet the needs of the Company. This job description and any attachments do not constitute or represent a contract.

QUALIFICATIONS AND SKILLS NEEDED:

(Key wording should include if degree is needed, any travel requirements, special qualifications needed, skills, etc.)

Education:

• BS/BA Degree in Life Sciences or related field preferred

or

• BS/BA Degree in computer sciences or related field

Experience:

• SAS BASE certified

• Minimum three years of experience with ADVANCED SAS products and procedures and/or one year experience in database design and data structures.

• Good understanding of the pharmaceutical drug development process.

• Strong organization, analytical and communication skills

• Detail-oriented

• Experience in implementing CDISC SDTM and Define standards. Including EG, CO, DM, RE, VS, SUPP CDISC SDTM domains.

• Experience with Windows and Microsoft Office products preferred.

• Strong written and verbal communication skills.

• Fluency in English (spoken and written).