Job Description

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.

Senior Clinical Data Associate

Job Summary:

Performs clinical data management activities in support of clinical a research studies as a senior 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 Trial Master Files for multiple projects

• Perform query management including data listing review, query creation and resolution on multiple studies as

needed to assist lead Clinical Data Managers

• Performs independent central data review in support of various risk-based monitoring solutions; reviews

reports, graphs, visualizations, quality tolerances, listings, key performance indicators to ensure cross site

excellence and risk mitigation.

• Mentor and train Clinical Data Associates in clinical data review and other CDA activities

• Assist and create study level metrics, as necessary

• Ability to work on multiple deliverables for different studies, as required

• Identity data issues and follow-up with relevant functional teams

• Perform/ Supervise 3rd Party Reconciliation Serious Adverse Event Reconciliation

• Adhere to all aspects of the SDC\xe2\x80\x99s quality system

• Comply with SDC\xe2\x80\x99s 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

• Able to perform all Clinical Data Associate job responsibilities with minimal supervision

• Take ownership of all study deliverables assigned to Data Review Center of Excellence.

• 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

• Working knowledge of clinical trials and data management\xe2\x80\x99s role in the clinical trials process

• Proficiency with Microsoft Word and Excel software and other MS office products

• Ability to work well independently and 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

• Familiarity of regulatory guidelines (FDA/CFR, ICH/GCP)

• Additional skills include the following: familiarity with electronic data capture systems and/or clinical research coordinator role

Education or Equivalent Experience

• Bachelor\xe2\x80\x99s degree, preferably in applied or life science, with at least 3 years of experience in data management of clinical trials or equivalent education and work experience.

Why SDC

• 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\xe2\x80\x99s 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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Statistics & Data Corporation (SDC)