Clinical Trial Manager I
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: New Jersey • United States
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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; 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, as required/appropriate
- 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 such as protocol deviation/violations and pharmacovigilance issues
- Supports subject/patient recruitment, retention and awareness strategies
- Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
- Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets
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
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
site qualificationsite initiationinterim monitoringsite managementdata entryprotocol complianceinformed consentclinical data integritypharmacovigilancesubject recruitment
Soft skills
communication skillspresentation skillsinterpersonal skillsjudgmentadaptabilityproblem-solvingdiligenceteam collaborationaction planningconfidentiality
Certifications
Bachelor’s degreeRN