Clinical Trial Manager

Clinical Trial Manager

Location:

DEU-Remote

• Perform site qualification, site initiation, interim monitoring, site management activities and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance; evaluate overall site and staff performance and provide recommendations, communicate/escalate serious issues, and develop action plans.
• Verify informed consent procedures are performed and documented for each subject/patient; protect confidentiality; assess factors that may affect subject safety and data integrity, including protocol deviations, violations and pharmacovigilance issues.
• Conduct source document review, verify clinical data entered in case report forms is accurate and complete, resolve queries remotely or on‑site, and ensure adherence to electronic data capture requirements.
• Perform investigational product inventory, reconciliation, storage and security reviews, and ensure the product is dispensed and administered per protocol; manage IP labeling, import, release and return.
• Review Investigator Site Files for accuracy, timeliness and completeness; reconcile contents with the Trial Master File; ensure archiving of essential documents per local guidelines.
• Document activities via confirmation letters, follow‑up letters, trip reports, communication logs and required project documents; support subject recruitment, retention and awareness; enter data into tracking systems to monitor observations, status and action items.
• Understand project scope, budgets and timelines; manage site‑level activities and communication to meet project objectives and deliverables; promptly adapt to changing priorities with oversight from the Lead CRA.
• Act as primary liaison with project site personnel or collaborate with other CRAs or Central Monitoring Associates; ensure all assigned sites and project‑specific site team members are trained and compliant.
• Prepare for and attend investigator meetings and sponsor face‑to‑face meetings; participate in global clinical monitoring/project staff meetings; attend clinical training sessions as required.
• Provide guidance toward audit readiness standards and support preparation for audits and required follow‑up actions.
• For Real World Late Phase, perform site support throughout the study lifecycle from site identification to close‑out; maintain knowledge of local requirements for real world late phase study designs; conduct chart abstraction activities and data collection; collaborate with sponsor affiliates, medical science liaisons and local country staff.

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Strong computer skills and ability to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.
• US ONLY:
  Employment may require deployment to sites that need medical and other personal information for facility access; compliance with site requests is required and failure to provide requested information may result in barring from entry and potential employment risk.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at