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Sr. Project Manager
Academic CRO Division
Primary responsibility as Project Manager is the management, conduct administration of European multi-country clinical studies
- Develop, review and manage appropriate study documentation in the trial master File (TMF)
- Periodically review study files for accuracy and completeness.
- Develop study related documents (FAQ, Guidance, forms, etc.)
- Manage study related invoice and track study-specific payments
- Set up and maintain tracking systems and tools
- Oversight of the monitoring activities at site and CRA’s/monitors
- Attendance at the study team teleconferences/face to face meetings and to write the meeting minutes
- Organisation of other meetings: CRAs, Study Investigators, Steering Committee, Data Safety Monitoring Board, etc.
Project Manager helps the Chief Investigator and scientific team of Studies in the development of their protocol and study documents
- Review protocol and patient consent forms: design, protocol writing, editing
Support the participating institutions making constant liaison with the centres, investigators and Sponsor spread over Europe for all activities related to implementation of the Clinical trial locally.
- Facilitate Site selection visit Identify the national coordinating investigator
- Collect, review and approve regulatory and ethical documents & register approval in the appropriate document tracker and save document in the electronic and paper file
- On-site visit and training to Investigators
- Investigator fee budget reports distribution to the sites
Project Manager Oversee the Clinical Research Associates (CRAs) spread over Europe for all activities related to monitoring of the Clinical trial locally.
- Selection of CRAs
- Monitoring Guidelines
- Training of CRAs
- CRAs teleconferences for coordination of monitoring
- Site initiation Visits
- Co-Monitoring Visits
- Data collection and data cleaning coordination and monitoring
- Monitoring report review
- Budget review and invoice tracking
Project Manager Oversees the Clinical Trial Assistant (CTAs) for all activities related to the Quality maintenance of the Clinical Trial Master File.
- Selection and coaching of CTAs
- Training of CTAs
- CTAs teleconferences for coordination of TMF activities
- Lead and coordinate during client in-house audits
- Budget review and invoice tracking
Project Manager acts as a central contact for the clinical team for project communications and roll out of all steps related to the clinical projects
- Liaison between the study sponsor and site, attend regular Project Teleconferences
- Provides Report to the Research Manager and to the study Sponsor on study steps, budget and recruitment
- Organise study meetings/phone conference and write meeting minutes with both the Sponsor and the CRAs/monitors
- Write and Send study specific Newsletter/Reports
Project Manager collaborates with the Data Manager and study statistician assigned to the project
- Project Manager reviews the DM documents such as the patient questionnaire, the database web-based questionnaire, data cleaning documents. You will also communicate on statistics with the assigned Biostatistician.
- Take part in the review of the study questionnaire (paper CRF)
- Take part in the review of database and web-based questionnaire (eCRF): plan, enforcement, process, testing
- Communicate with DM regarding need for reports on data entry follow-up to track investigator fees payments
- Data cleaning coordination: plan, process and reporting
- Statistics & report writing coordination: plan, process and reporting
Project Manager reports to the Research Manager and escalate issues to Research Manager and Study Sponsor
- Use the escalation process during weekly team meetings or proactively seek for meetings to escalate any issue
Project Management related activities for other Research projects as needed, including EU funded projects for which the organisation has a role. This will be decided by the Research Manager.
Skills and personality
- Time Management, good organisational skills
- Team player with the ability to work independently and autonomously
- Leadership skills
- Profound knowledge of Microsoft Office (Word, Excel, PowerPoint and Outlook) and internet use
- Knowledge of good clinical practices and standard operating procedures
- At least 5 years of relevant experience in project management within Pharmaceutical Clinical Trial sector
- At least 2 years’ experience of monitoring sites. Experience of overseeing CRAs including reviewing monitoring visit reports, training CRAs and co-monitoring is a plus.
- Ability to use judgment to effectively solve problems
- High degree of initiative and self-motivation with a strong sense of accountability
- Excellent communication skills in English both oral and written. Any other language is a plus
minimum 5 years
Higher Scientific Degree
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