Senior Clinical Data Associate

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 experience 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, positive work/life balance and 401k matching (US), we are able to attract some of the most talented people in the industry.

WHY SDC:

• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling out growth in this ever- evolving industry.
• 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 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 strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
• With a proven track record, SDC has been successfully executive client clinical programs since 2005.

Take a look at how you can join our team!

The Senior Clinical Data Associate coordinates data management activities in support of clinical and/or non-clinical research studies including document management, query management, database setup and testing, and quality control of the data and project deliverables.

Primary Responsibilities

• Assist Clinical Data Manager in allocating and prioritizing workloads for multiple projects, as needed
• Maintain quality control of the data, project deliverables and closeouts
• Perform data entry and query management including data listing review, query creation and resolution
• Mentor and train Clinical Data Analysts in query management and other CDA activities
• Assume Clinical Data Manager responsibilities for small studies
• Generate, send and track receipt of Training Forms for new database users; complete User Access Request Forms
• Track and maintain audit-ready clinical study documentation within the electronic and/or hard copy Trial Master Files for multiple projects
• Participate and/or lead internal and external team meetings, as necessary
• Participate in database setup including programming specification document creation and review, data entry screen and validation check writing and testing, Case Report Form Completion Guidelines development, etc.
• Serve as an interim resource for study issues pertaining to data management in the absence of the Clinical Data Manager

Requirements

• Familiarity of regulatory guidelines (FDA/CFR, ICH/GCP)
• Working knowledge of clinical trials and data management’s role in the clinical trials process
• Proficiency with Microsoft Word and Excel software and other MS office products (MS PowerPoint, MS Project, etc.)
• Excellent organizational skills and attention to detail
• Ability to work well in a team environment
• Effective communications skills both written and verbal
• Additional skills include the following: familiarity with electronic data capture systems and/or clinical research coordinator role
• Ability to successfully work on multiple projects and prioritize daily tasks and responsibilities
• Possess strong problem-solving skills, be solution-oriented

Education Or Equivalent Experience

• Bachelor’s degree, preferably in applied or life science, with 1-3 years of experience in data management of clinical trials or equivalent education and work experience.

Benefits

What you can expect from us:

• Short-Term & Long-Term Disability
• Life Insurance (Basic, Voluntary & AD&D)
• Health Care Plan (Medical, Dental & Vision)
• Family Leave (Maternity, Paternity)
• Retirement Plan (401k)
• Work From Home
• Paid Time Off (Vacation, Sick & Public Holidays)
• Profit based incentive
• Training & Development