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Wednesday, 17 May 2017

Data Standardization Services Associate (DSS Associate)

Job Location:     Trivandrum, India

Job Overview:      

The Data Standardization Services Associate supports data standardization services for all types of data collected and utilized in clinical trials in accordance with Clinipace Worldwide SOPs, ICH Guidelines, Regulatory and/or Sponsor requirements.

Job Duties and Responsibilities:

The specific job duties of a DSS Associate may include but are not limited to:

Assists with data standardization services and data management activities in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study documentation.

Study status tracking
Data Entry
Safety Data Management and Reporting -  assists with the entry and processing of defined SAE cases into the safety database and/or clinical database and creation of safety reports to assist SAE Management.
Reports generation – assists with the review and generation of reports for project management and site management activities
TM/TMF Migration and Filing – assists with the archiving of critical documents on an ongoing basis
Study Report Testing - assists with the testing of the study reports
Management of TempoCal entries
User Acceptance Testing – assists with the UAT of the clinical databases
Data Review – assists with data validation and reconciliation of clinical data with the help of clinical database, data listings, identifying the data discrepancies, query generation and updating of database with query resolutions
Perform any ad-hoc activities or related duties as assigned
Participation in appropriate project team meetings
Manages time in accordance with allocated hours for task
Participates in departmental and organisational meetings and initiatives

Supervisory Responsibilities:

This job involves no supervisory responsibilities for other employees or contractors.

Job Requirements:

Education

College graduate in life sciences, computing, or similar degree, or clinical/nursing qualifications.
Experience
Basic computer skills as relevant to the job function. Experience using any data management applications/software preferred.
Experience in medical terminology is preferred.
Skills/Competencies
Excellent organizational, communication, and time management skills
Professional approach to the work environment
Professional written and verbal communication skills
Exceptional attention to detail. Must have the ability to understand and accurately interpret procedures
Good problem-solving skills
Capabilities
Flexibility – willing to work beyond the normal hours and/or weekends on occasions to accommodate project demands
Shift requirements – willing to work in rotational shifts
Team player – effective proactive participant as a team member

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Contact : Mr.Venkat Ramana Reddy
Address :  4-38, Vikas Nagar, Near Rajadhani Theater,
DilsukhNagar, Hyderabad, Telangana-500060
Num : 8 143 145 141

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