Clinical Operations Manager – Regulatory, SSU Management
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇸🇦 Saudi Arabia
Visit company websiteJob 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 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; immediately communicates/escalates serious issues to the project team and with guidance develops action plans
- 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
- Assesses factors that might affect subject/patient’s safety and clinical data integrity
- Supports subject/patient recruitment, retention and awareness strategies
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings
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
- 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 managementprotocol complianceinformed consentclinical data integritysubject recruitmentretention strategiespresentation skills
Soft skills
communicationinterpersonal skillsjudgmentproblem-solvingaction planningteam collaborationadaptabilityorganizational skillspresentationleadership
Certifications
Bachelor’s degreeRN