Clinical Operations Leader - Multiple Locations Available (Europe & India)
Parexel International Corporation
Working as a Clinical Operations Leader 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, line management, or other positions, we have a world of opportunity waiting for you.
Our Clinical Operations Leaders are valued members of our clinical studies teams, working from their home office base, supporting studies within their country, region or even 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 Clinical Operations Leader 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 with CROs 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.
As a core member of the global cross-functional Clinical Trial Team (CTT), participate and report study progress and issues/resolution plan at the CTT meeting; write CTT meeting minutes. Contribute to defining the Data Review Plan and participate in data review as required.
Support Associate Global Trial Director/ Global Program Trial Director in overseeing third-party Investigator Initiated Trials (ITTs) and regional and locally sponsored trials where necessary. Collaborate with local and regional teams to track study progress, update databases and support budget oversight.
Contribute to the development of clinical sections of regulatory documents such as Investigators’ Brochures, safety updates, etc.
Responsible for education, implementation, and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) including sharing lessons learned.
What you’ll need to join us as a Clinical Operations Leader:
Skills and Education:
Advanced degree or equivalent education/degree in life science/healthcare recommended.
Fluent English (oral and written).
2-5 years of experience in similar roles.
Recent Global trials experience is preferred.
Experience in Oncology trials is preferred.
Involvement in cross-functional, multicultural, and international clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities.
Excellent communication, organization, and tracking skills.
Proven ability to work either independently or in a team setting, to meet goals by managing compliance, budget, and timelines.
Proven networking skills and ability to share knowledge and experience amongst colleagues.
Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.
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