Our client is a leading, therapy-focused data services CRO providing expert clinical trial services: Biostatistics and eClinical Services to ensure your clinical data is ready for submission. They combine advanced Biostatistics, regulatory and medical expertise, and innovative integrated eClinical Solutions to increase efficiency and mitigate risks throughout the drug development process.
The Project Manager is the key client contact for projects. The company is performing multiple tasks (randomization & trial management systems (RTSM), clinical data management, client support and system validation, biostatistics, and/or medical writing). His/her role will be to ensure that the project is completed on time, within budget, and with high quality meeting the client’s expectations.
As a Project Manager, your key responsibilities will be to:
- Oversee the project team providing RTSM, clinical data management and statistical analyses for clinical trials.
- Ensure optimal relationship with clients by day-to-day communication, project meetings, reporting, and quality assurance.
- Ensure a positive relationship between different departments to ensure optimal data processing and efficient communication.
- Ensure that appropriate documentation is filed in the Trial Master file and that the services are produced and maintained for each project.
- Create and maintain the project planning and ensure that milestones and Team Lists are up to date and communicate to team in case of modifications.
- Assist Quality Assurance to prepare customer audits of their projects, and attend the audit as necessary.
- Detect, resolve and/or escalate project problems and conflicts.
- Review contract and budget amendments.
- Perform regular project budget analysis in order to ensure that the project is on time and in budget.
- Ensure that team members assigned to the project receive the appropriate project specific training.
- Develop and update SOPs/WINs/Guidance documents with respect to Project Management processes.
A unique opportunity to work in an innovative, dynamic and future-oriented company. A strong international environment.