Syneos Health

Syneos Health

Clinical Trial Manager II

CAN-QC-Montreal · Mid

Sponsorship not specifiedDetected 3 days ago
GCPComplianceProject ManagementClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceResearchLeadershipCommunicationProblem SolvingCritical ThinkingGxP

About the role

  • Clinical Trial Manager II Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.
  • Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed.
  • Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements.

Responsibilities

  • Further, nothing contained herein should be construed to create an employment contract.
  • We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
  • Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
  • We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.
  • We are committed to building an inclusive culture - where you can authentically be yourself.
  • Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
  • We are continuously building the company we all want to work for and our customers want to work with.

Requirements

  • Demonstrated expertise in site management and monitoring (clinical or central)
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Moderate travel may be required, approximately 20%
  • Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
  • 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.
  • Demonstrates understanding of clinical trial management financial principles and budget management
  • 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
  • Get to know Syneos Health

Nice to have

  • Preferred experience with risk-based monitoring

Benefits

  • Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.
  • 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.
  • Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Company info

  • The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
  • The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
  • The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Visa & Work Authorization

  • 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 timeline
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This listing is sourced directly from Syneos Health's careers page and normalized into a canonical job model.