Working as a Senior Global Trial Manager at Parexel FSP offers tremendous long-term job security and prospects.
We undertake vital clinical studies for sponsors including the leading global Biotechs and Pharma top 50, and we have an incredible pipeline of work.
Whether you see your future path in project management or other positions, we have a world of opportunity waiting for you.
Our Senior Global Trial Managers are valued members of our clinical studies teams, working from their home office base, supporting studies globally.
'Manageable' is our mantra.
Expect exciting professional challenges on inspiring studies, but with time for your outside life.Purpose of the role:Parexel FSP supports clinical studies across the full range of oncology and non-oncology therapeutic areas, and we have longstanding partnerships with a vast client base.
Dedicated to one key Oncology-focused sponsor, the Senior Global Trial Manager contributes (with appropriate oversight) to all aspects of the assigned global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance, and performance standards.What you'll be doing:At Parexel FSP we believe strongly in work/life balance; we'll take your well-being just as seriously as we do that of our patients.
To us, that's what 'working with heart' is all about.
Contributing to all operational trial deliverables, responsibilities include (but are not limited to):Development of specific sections of the protocol and related documents.Development of study tools, guidelines, and training materials.Organization and logistics of various trial advisory committees (e.G., Data Monitoring Committee, Steering Committee).Ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.G., trial results registries).Contributing to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations; managing interface withCROs in cooperation with outsourcing management and line functions; ensuring vendors meet quality standards; contributing to the development/amendment of vendor contracts.Contributing to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, and statistical programmer.Implementing issue resolution plans.Acting as point of contact for all site-related issues and procedural questions.When necessary, ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.Resource Management - support the Global Program Trial Director with the development, management and tracking of the trial level life cycle budget including forecast and annual cost targets.#J-18808-Ljbffr
