Syneos Health

Clinical Operation Lead – Clinical Trial Manager

Syneos Health

full-time

Posted on:

Location Type: Remote

Location: Belgium

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Job Level

Senior

About the role

  • provide supporting services to the Clinical Trial Manager/operational team in execution of the trial(s)
  • maintain effective communication with the project team through oral and written correspondence and status reports to ensure alignment with study timelines
  • reviewing, developing, and writing clinical trial documents and manuals, including study manuals, laboratory or biomarker plans, and other supporting documents
  • creation of the master ICF template and review/approve site changes (in consultation with legal, safety when warranted)
  • update template for new risks and new amendments information
  • feasibility and evaluation of investigative sites
  • working closely with the Clinical Trial Logistics group as well as coordinating and monitoring activities at investigational sites
  • review monitoring trip reports and supporting the monitoring organization
  • develop relationships with investigational sites and institutions to enhance conduct of the trial
  • oversee user acceptance testing (UAT) as needed
  • ensures access and audit trail reviews are conducted as required
  • coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.

Requirements

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
  • At least 3 years of relevant experience for the COL and at least 5 years of relevant experience for the Sr COL
  • 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) TA experience; oncology early development, infection & auto immune disease is a big pre
  • Study start-up experience in different regions (global experience)
  • Demonstrates understanding of clinical trial management financial principles and budget management
  • These are global roles and experience in multiple regions is a requirement
  • 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.
Benefits
  • career development and progression
  • supportive and engaged line management
  • technical and therapeutic area training
  • peer recognition and total rewards program
  • Total Self culture
  • employees can authentically be themselves.
Applicant Tracking System Keywords

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

Hard Skills & Tools
clinical trial managementsite managementmonitoringstudy start-uprisk managementbudget managementclinical trial documents writinguser acceptance testingdata plansprotocol specificities
Soft Skills
communicationteam leadershipproblem solvingcritical thinkingrelationship buildingorganizational skillsalignment with project milestonesadaptability in international environmentstraining coordinationcollaboration
Certifications
Bachelor’s degreeRN