Syneos Health

Clinical Trial Manager I – FSP

Syneos Health

full-time

Posted on:

Location Type: Hybrid

Location: Bucharest • 🇷🇴 Romania

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Job Level

Mid-LevelSenior

Tech Stack

Google Cloud Platform

About the role

  • Performs 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
  • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions
  • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient
  • Demonstrates diligence in protecting the confidentiality of each subject/patient
  • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site

Requirements

  • 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
  • Must demonstrate good computer skills and be able to embrace new technologies
  • Excellent communication, presentation and interpersonal skills
  • Ability to manage required travel of up to 75% on a regular basis
Benefits
  • supportive and engaged line management
  • technical and therapeutic area training
  • peer recognition and total rewards program

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
site qualificationsite initiationinterim monitoringsite managementregulatory complianceICH-GCPGood Pharmacoepidemiological Practicesinformed consent documentationclinical data integritysafety assessment
Soft skills
judgmentexperience evaluationrecommendation skillsdiligenceconfidentiality protectioncommunication skillspresentation skillsinterpersonal skillsadaptability to new technologiestravel management
Certifications
Bachelor's degreeRN