Data QC Team Lead (Clinical Research

Company: Celerion
Location: Tempe
Posted on: April 5, 2021

Job Description:

Data QC Team Lead (Clinical Research) in Tempe, Arizona, US at Celerion Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion offers one of the most experienced clinical pharmacology research networks in the industry. The Data Quality Control Team Lead is a staff management position within the Data Management team of our phase one research clinic in Tempe, AZ. This position is responsible for managing the data workflow through Quality Control (QC) and Data Entry (DE) for clinical studies, maintains timelines for client deliverables, and ensures regulatory compliance.-- This is a fulltime position which coordinates the work product of approximately 15 Data Entry & Data QC associates, and is accountable for the work flow and process management and of these two work teams. Additionally, this role collaborates with other departments and clinical sites and engages with Sponsors.-- We seek an excellent communicator, people manager, and process manager who is well-versed in the data entry and data QC process of phase one clinical trial databases.-- Essential Functions:

• Responsible for staff management in accordance with the organization's policies and applicable laws
• Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees
• Communicate and provide support/guidance to appropriate groups/staff as required to ensure established, revised and/or new processes are followed to ensure quality on-time/zero defect standards
• Plan, organize and facilitate workloads and schedules of staff to ensure that timelines are met and are compliant with regulatory and internal procedure requirements.
• Attend and participate in study specific meetings related to study set up, timeline production and management, and study status
• May be required to carry out study tasks, including but not limited to, complete QC review of source data and raw data for studies, performing accurate data entry, attending internal study initiation meetings to determine QC criteria and timelines for studies
• Write QC and DE SOPs and Procedure guides and participate in SOP and Procedure Guide Reviews
• Create and track metrics associated with QC and DE responsibilities
• Present the QC processes to sponsors and auditors
• Lead Process Improvement initiatives to improve the quality of the source data Job Requirements Knowledge/Skills/Education/Licenses:
  • Bachelor's field in a related degree required.
  • 3+ years of professional experience in clinical research data work (phase one preferred)
  • 1-2 years supervisory or trainer/leader experience required.
  • Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred
  • Prior task/project management experience involving staff planning and forecasting.--
  • Ability to manage multiple projects/priorities required
  • High attention to detail required
  • Excellent oral and written communication skills required
  • Excellent organizational skills required
  • Proficiency in MS office applications required Celerion Values: Integrity Trust Teamwork Respect Are you ready to join our team? Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

Keywords: Celerion, Tempe , Data QC Team Lead (Clinical Research, Healthcare , Tempe, Arizona