Principal Clinical Data Associate

847

Workplace Type: Remote

The Principal Clinical Data Associate (“CDA”) will have experience in all required areas of a Senior Clinical Data Associate. The Principal CDA is responsible for data review associated activities and support to the Lead Data Manager for assigned studies. The Principal CDA will be assigned to complex studies and is expected to coordinate and review the work of other CDAs assigned to their studies as supplemental support.

 Responsibilities: 

• Follow departmental and company procedures with quality
• Provide input on database design and associated documentation
  1. Review and provide input on draft eCRFs and participate in eCRF screen review meetings
  2. Review and provide input on edit check specifications
  3. Review and provide input on Data Management Plan
• Author and maintain eCCGs
• Author and maintain study-specific training slides for SIVs
• Conduct user acceptance testing; including, but not limited to, eCRFs, edit checks, database roles, database modules such as RTSM, ePRO, etc.
• Draft database change log and conduct MSU impact assessment
• Draft Data Transfer Specifications
• Write programming specifications for data review, reconciliation, metric report and custom report outputs
  1. Responsible for test data entry and UAT
• Responsible for data review activities as specified for the study; including coordination of activities for CDAs assigned to the study for supplemental support
  1. DM Review
  2. Discrepancy management
  3. Manual data/data listing review
  4. External vendor reconciliation, maintenance of issue tracker and communicate with vendor regarding issues
  5. SAE reconciliation
• Run and report on study metrics
  1. Identify and address trends and inconsistencies
  2. Maintain the clean patient tracker
• Responsible for local lab data handling data entry of reference ranges, quality control and tracking; including coordination of activities for CDAs assigned to the study for supplemental support
• Perform user account management
• Perform data quality control review; including query QC, audit trail and user accounts
• Actively participate in sponsor meetings (depending on time zone)
  1. Take meeting minutes
  2. Facilitate data related discussions
• Perform EDC archival tasks
• Maintain awareness of the contracted scope of work for assigned studies and communicates status updates to the assigned Lead Data manager as necessary
• Serve as subject matter expert
• Provide training and mentoring for other Clinical Data Associates
• Participate in department initiatives and process improvements
• May participate in the development and revision of department SOPs
• May be expected to perform the duties of the Lead Data Manager role as needed, based on business requirements and competency in the role
• Perform other duties as requested by management

Qualifications: 

• Education
  1. Bachelor’s Degree preferred, equivalent combination of education and relevant experience may be considered
• Training
  1. Working knowledge of clinical research best practices preferred
  2. Excellent oral and written communication skills, organizational skills, and attention to detail are required
• Experience
  1. Minimum of 4 years direct data management experience in pharmaceutical development, CRO, or clinical research environment

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.