Job Title: Clinical Trial Monitor
Type: 6 Months Contract w/extension possibilities
Travel: Up to 50%
Responsibilities:
- Responsible for coordinating clinical monitoring activities.
- Overseeing the CRO clinical /site management activities and co-monitoring the assigned international Ph-I to Ph-III clinical studies.
- Coordinate the achievement of assigned clinical study deliverables within a matrix organization under the leadership of the Clinical Project Managers (CPM).
- Be a representative at site and build relationship with investigators.
- Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organization and preparation of the monitor and investigator meetings.
- Collaboration with the CPM in the RFP process and participation to BID defense meeting
- Participate in the ongoing clinical study data reviews in collaboration with the other study team members.
- Make appropriate and timely reporting in CTMS with regular checks for quality and accuracy.
- Ensure the agreed timelines for data collection (CRF/eCRF) and data clarifications/queries are met, sending information to data-management and monitoring CROs as appropriate.
Requirements:
- Experience coordinating clinical/site management activities for the set up and running of international registrational studies (multiple sites/countries).
- 3 years Field CRA monitor experience (CROs or Pharma Industry)
- Experience in preparing clinical study documentation for study set up, maintenance and closing
- Experience in managing and developing relationships with CROs.
- Global studies (multiple countries/sites) experience
- Therapeutic area of studies (Neuroscience OR Oncology)
