Syneos Health® is a leading fully-integrated life sciences services organization dedicated to accelerating customer success. We partner with innovators throughout the drug development and commercialization continuum, helping them navigate complexity and drive progress.

Our Clinical Solutions team members operate with a drug development mindset, leveraging their extensive experience to understand customer needs and shape effective solutions. In this role, you will work in either a Functional Service Provider partnership or a Full-Service environment, collaborating with passionate problem solvers to help our customers achieve their goals. We are agile and committed to delivering results for one another, our customers, and ultimately, those in need.

About the Company

Syneos Health has collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products over the last five years, conducting over 200 studies across 73,000 sites and 675,000+ trial patients.

The Role

As a Clinical Data Manager, you will perform activities related to Phase I-III clinical trials, ensuring compliance with ICH/Good Clinical Practices (GCP) and relevant guidelines. You will manage assigned trials to ensure timely completion, budget adherence, and high-quality standards.

Responsibilities

• Serve as the primary data management representative on multidisciplinary project teams, ensuring effective communication.
• Communicate key clinical data management metrics and collaborate with the study team to determine appropriate actions.
• Review, develop, and write clinical trial documents and manuals, including Case Report Forms and Data Management Plans.
• Participate in User Acceptance Testing (UAT) and Quality Control (QC) as required.
• Collaborate with Clinical Database Programmers to develop Data Flow Charts and Data Transfer Specifications.
• Assist with site and vendor training on CDM-related topics.
• Provide data review training and guidance to Sr. Clinical Data Coordinators.
• Perform data review and discrepancy resolution as needed.
• Archive trial documentation upon completion.
• Ensure adherence to Good Clinical Practice and applicable regulations.

Requirements

• Minimum of 5 years of data management experience.
• Bachelor's degree or certification in a related allied health profession preferred; equivalent experience will be considered.
• Experience with Electronic Data Capture (EDC) systems required; familiarity with Oracle Inc.'s Inform™ EDC preferred.
• Oncology and/or inflammatory therapeutic area experience preferred.
• Project management experience within Data Management preferred.
• Previous work history at a Clinical Research Organization (CRO) or CRO management experience in data management preferred.

Join us at Syneos Health and be part of a team that is shaping the future of healthcare. Discover more about us at http://www.syneoshealth.com.