Clinical Trial Manager

Syneos Health

Clinical Trial Manager ensuring regulatory compliance and site performance in clinical trials. Collaborating with global teams to achieve patient progress and project objectives.

Posted 7/14/2026full-timeRemote • 🇩🇪 GermanyMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Good Clinical Practice (GCP) and ICH Guidelines, ensuring compliance and integrity in clinical trial processes. Proficient in site management, data verification, and effective communication with site personnel to support project objectives and audit readiness.

Highest-signal resume keywords

Good Clinical Practice (GCP)ICH GuidelinesSite ManagementData VerificationClinical Trial Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site QualificationSource Document ReviewInformed Consent VerificationClinical Data Integrity AssessmentQuery Resolution Techniques

Soft Skills

Excellent Communication SkillsInterpersonal SkillsPresentation SkillsAdaptability

Tools & Technologies

Electronic Data CaptureTracking SystemsClinical Monitoring PlanSite Management Plan

Certifications & Qualifications

Bachelor’s DegreeRegistered Nurse (RN)

Industry Keywords

Clinical MonitoringPharmacovigilanceTrial Master File (TMF)Investigator Site File (ISF)Audit Readiness

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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
For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes
Conducts Source Document Review of appropriate site source documents and medical records
Verifies required clinical data entered in the case report form (CRF) is accurate and complete
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture
Verifies site compliance with electronic data capture requirements
May perform investigational product (IP) inventory, reconciliation and reviews storage and security
Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
Verifies issues or risks associated with blinded or randomized information related to IP
Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned
Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness
Reconciles contents of the ISF with the Trial Master File (TMF)
Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
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
For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets
May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA)
Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings
Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions

Requirements

What you’ll need

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

Comp & perks

We are passionate about developing our people, through career development and progression
supportive and engaged line management
technical and therapeutic area training
peer recognition and total rewards program
We are committed to building an inclusive culture – where you can authentically be yourself