Clinical Trial Manager I
Syneos Health
Google Cloud Platform
Senior Clinical Trial Manager II
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇪🇸 Spain
Visit company websiteJob Level
Senior
About the role
- Support the development and review of the Clinical Study Blueprint (CSB) and Protocol, and all Amendments and/or Administrative Changes
- Manage the execution of the CDAs; support Project Managers in the creation of overall study budget (working with the contract/budget analyst)
- Assist in development of Investigator Site Selection Plan; attend country and site selection Jams; assist with creation of Feasibility Questionnaire
- Stay informed of progress with CDAs, CSA and site budgets; support sites for contract amendments
- Oversight of site payments and vendor payments, if applicable
- Draft and facilitate the Clinical Study Budget review
- Support the planning for the clinical study timelines, finalization and update
- Assist/support in the creation/finalization of Study Specific Training (TA training, Compound, Study Design, Vendors, Eligibility, etc)
- Review updates to Data Management Plan; Interim/Final Database Lock Preparation
- Develop site closure plan
- Assist Project Managers in development of patient recruitment strategy and plan; develop recruitment materials
Requirements
- 2 years or more of experience as CTM, managing multiple countries, for regional or global trials
- Experience with vendor management is required
- Oncology Experience
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Demonstrated ability to lead and align teams in the achievement of project milestones
- Demonstrated capability of working in an international environment.
- Demonstrated expertise in site management and monitoring (clinical or central)
- Preferred experience with risk-based monitoring
- Demonstrates understanding of clinical trial management financial principles and budget management
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills
- Good communication, presentation and interpersonal skills among project team and with sites
- Strong conflict resolution skills
- Demonstrated ability to apply problem-solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
- Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
- Moderate travel may be required, approximately 20%
Benefits
- Career development and progression
- 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
Clinical Study BlueprintProtocol developmentBudget managementSite managementMonitoringRisk-based monitoringData Management PlanPatient recruitment strategyFeasibility QuestionnaireClinical trial management
Soft skills
LeadershipTeam alignmentCommunicationPresentationInterpersonal skillsConflict resolutionProblem-solvingCritical thinkingCollaborationAdaptability
Certifications
Bachelor’s degreeRegistered Nurse (RN)Good Clinical Practice (GCP) certificationICH Guidelines training
