Clinical Data Manager II in Aliso Viejo, California

Clinical Data Manager II

Join our dynamic team as a Clinical Data Manager II, where you'll play a pivotal role in managing data for clinical studies from start to finish. This position offers an exciting opportunity to utilize your project management and analytical skills in a collaborative environment.

Responsibilities

• Develop and manage key documents such as Data Management Plans and Project Plans.
• Lead User Acceptance Testing for clinical databases and ensure timely delivery of study deliverables.
• Facilitate cross-functional meetings to support data management efforts.
• Conduct regular data reviews to identify trends and quality issues, generating queries as needed.
• Collaborate with programming teams to create customized reports for data review and cleaning.
• Assist in medical coding and reconciliation processes.
• Prepare training materials for various stakeholders involved in clinical studies.
• Contribute to the development of departmental processes and procedures.

Skills

• 2-5 years of experience in Clinical Data Management within the Pharmaceutical, Medical Device, Biotechnology, or CRO industry.
• Strong knowledge of FDA/ICH guidelines and data management practices.
• Proficiency in Electronic Data Capture systems and database concepts.
• Experience working with CDISC Standards (CDASH, SDTM).
• Excellent project management and communication skills.
• Ability to review data using various tools and generate actionable insights.

Preferred Skills

• Experience in the Ophthalmology therapeutic area.
• Familiarity with SQL, SAS, Excel, or other programming languages.
• BS or higher in biological sciences, nursing, or related health disciplines.

At Horizontal, we are committed to fostering a diverse and inclusive workplace where all individuals are valued and respected. We believe that diversity drives innovation and are dedicated to creating an equitable environment for all employees. By applying for this position, you acknowledge and agree that Horizontal Talent may contact you regarding your application using automated technology, including phone calls, SMS/text messages, or email, which may be delivered by our virtual AI recruiter, Alex.

Applications will be accepted for 4 weeks. For those that join the team, we offer competitive compensation and benefits including medical, dental, vision, and retirement. The pay range for this role is $22 - $29.23 per hour based on qualifications and experience.