Senior Clinical Data Associate

582

Workplace Type: On-site

The Senior Clinical Data Associate (“CDA”) will have experience in all required areas of a Clinical Data Associate. The Senior CDA is responsible for all data review associated activities for a clinical study. The Senior CDA may assist the Lead with additional data management activities.

Responsibilities:

• Exceed expectations and responsibilities of a Clinical Data Associate
• May assist in the creation of the DMP, eCCGs, Edit Check Specifications, data review listing specifications and other start-up documents
• Perform user acceptance testing
• May assist with EDC module integrations/setup (ePRO, Randomization, Dispensing, etc.)
• Review eCRFs in the database to ensure data consistency and completeness
• Perform manual data review and data listing review as defined on assigned studies
• Review and respond to answered queries by the site and issue re-queries as needed
• Generate manual queries
• Communicate potential data issues to the appropriate data management personnel
• Perform reconciliation of SAEs and external vendor data as required for assigned studies
• Identify data trends and report inconsistencies to applicable data management personnel; collaborate to develop and implement actions to address
• Perform user account management
• Collect and report on study metrics
• Perform data entry or quality control review of local lab data
• Perform Quality Control review
• Perform EDC archival tasks
• Standard Operating Procedures (SOPs)
  • Strong understanding of departmental and company procedures; ability to guide others on procedures

Qualifications: 

• Minimum of 3 years direct data management experience in pharmaceutical development or CRO environment
• Bachelor’s Degree preferred. Work experience may be substituted for degree
• Working knowledge of CDASH standards
• Excellent oral and written communication skills, organizational skills, and attention to detail are required

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

EEO Employer Verbiage:

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.