Senior Clinical Project Manager
|Job Title:||Senior Clinical Project Manager|
|Salary:||bonus, stock options|
|Start Date:||1st February 2017|
|Contact Name:||Vladyslav Babych|
|Job Published:||January 18, 2017 12:17|
- Coordinate, monitor and document activities of clinical development project progress.
- Contribute to design and required amendments of the following documents: investigator brochures, patient information and informed consent forms, case report forms, study manuals, monitoring plan, study tools, progress reports, final clinical trials reports,
- Escalate issues to management
- Ensure timely availability of critical documents and progress reports for upper management
- Ensure project planning and monitor execution of budgets and resources allocation.
- Effectively communicate the scope of work, project plan, quality expectations and timelines to project team members and stakeholders.
- Proactively anticipate and resolve issues with the project at early stages.
- Oversee directly and indirectly (through selected CRO), site selection and contracting.
- Manage relevant vendors to ensure their alignment with overall project plan and time lines
- Approve invoices from vendors and study sites
- Contribute to development and regular updates of processes, and SOPs.
- Ensure clinical documentation and submissions to IRB/ERBs and Regulatory
Agencies within appropriate project timelines, in collaboration with selected CRO and
the organisation Regulatory department.
- Ensure that all relevant documentation is updated on ongoing basis to E Trial Master File
- Ensure appropriate management of IMP supplies by assigned resources (ie vendors).
Skills & experience requirements
- Project Management and Clinical Development processes knowledge.
- Advanced scientific degree relevant to field of clinical research.
- Adequate knowledge of the clinical trial requirement according ICH/GCP and other clinical trials-related regulations/guidelines.
- Minimum 3 years clinical development experience in a clinical research environment
including leading clinical staff.
- Knowledge of oncology TA is advantage.
- Full proficiency in oral and written English
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