Clinical Data Associate I

1 day ago

Hyderabad, India Statistics & Data Corporation (SDC) Full time

**Clinical Data Associate I**

Statistics & Data Corporation (SDC), A global contract research organization (CRO) providing clinical trial solutions for pharmaceutical, biologic, and medical device/diagnostic companies since 2005. Our core expertise is strategic scientific consulting and clinical data services which include biostatistics, data management/EDC, and IRT/IWRS. We look forward to speaking with you to explore whether SDC is The Right Fit For You.

**Job Summary**:
Performs data management activities in support of clinical research studies, as a member of Data Review Center of Excellence, including review of clinical data, external vendor supplied clinical data, laboratory data, serious

adverse event data, unexpected adverse device events, query management (identification, generation, resolution review and close-out).

**Primary Responsibilities**
- Track and maintain audit-ready clinical study documentation in support of data and listing reviews within the
- electronic and/or hard copy Trial Master Files for multiple projects
- Perform data entry and query management including data listing review, query creation and resolution
- Perform 3rd Party Reconciliation and other study activities under supervision of a Senior or Principal CDA.
- Perform assigned study related activities within budgeted time
- Adhere to all aspects of SDC’s quality system
- Comply with SDC’s data integrity & business ethics requirements
- Perform other duties as assigned
- Adherence to all essential systems and processes that are required at SDC to maintain compliance to
- business and regulatory requirements
- The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

**Requirements**:
**Required Skills**:

- Basic proficiency with Microsoft Word and Excel software
- Ability to work well in a team environment
- Excellent organizational skills and attention to detail
- Ability to successfully work on multiple projects and prioritize daily tasks and responsibilities
- Effective communications skills both written and verbal
- Possess strong problem-solving skills, be solution-oriented
- Additional desired skills might include any of the following: medical terminology, familiarity with relational

databases/electronic data capture systems; clinical research coordinator experience; working knowledge of

clinical trials and Data Management’s role in the clinical trials process

**Education or Equivalent Experience**
Bachelor’s degree, preferably in applied or life science, and at least 1-2 years work experience.

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