Clinical Data Associate II

Clinical Data Associate II

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.

Job Summary

Performs data management activities in support of clinical research studies that includes 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 study related activities within budgeted time.

• Work with QC and QA teams to make the internal TMF ready for study deliverables in regard to data review, reconciliation and listing documentation.

• Perform study conduct activities including, but not limited to Query Management, Listing Review

• Perform 3rd party reconciliation and SAE reconciliation as assigned.

• 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

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 3 years work experience

Why SDC

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.

• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.

• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.

• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

• With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

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