The Clinical Project Manager is a key operational role where you will act as the primary point of contact between OPIS and the client to provide customer-focused leadership.
Some of what you will do:
Coordinate and oversee project activities
Organize project activities and evaluate timeframes
Manage the administrative aspects of studies
Manage study materials (re-supply/drug expiration/re-labelling of drugs, various materials)
Prepare study specific procedures and tools (if applicable)
Review and approve the Investigator’s Folder and Trial Master File prototype
Verify compliance with operating procedures
Ensure that the monitoring activities are conducted as per monitoring plan requirements
Review monitoring, remote monitoring, contact and telephone contact reports
Send regular updates to the Sponsor
Ensure that the enrollment curve is on track and take actions in case of under-performance
Check compliance with timeframes, quality and contractual requirements
Propose and guarantee the implementation of action plans that resolve issues and/or improve processes
Properly and timely escalate relevant issues to his/her direct superior and to the Clinical Team (if applicable)
Update/check the Trial Master File of the studies (country) according to OPIS and/or Sponsor procedures
Ensure that the site TMF are checked by the monitoring team according to OPIS and/or Sponsor procedures Keep track of terminating studies and do the final check of the completeness of TMFs
Maintain contacts with clinical staff as necessary
Manage relationships with Data Centers
Perform co-monitoring visits with CRAs, if necessary
Coordinate/participate in Investigator’s Meeting, Monitor’s Meeting and project meetings
Participate in periodic meetings held by the Sponsor to plan activities
Plan and hold study specific meetings with CRAs, as necessary
Ensure that the monitoring team is trained on study specific procedures and aspects
May act as Clinical Project Leader for international projects
Collaborate to on-boarding of new associates and act as a mentor of junior staff
Collaborate in establishing and maintaining SOPs related to Clinical Operations Unit
Enter all the information required in the TRACK system on an ongoing basis
Moreover, the Clinical Project Manager can conduct Feasibility, Pre-study Visit, Site Initiation Visit, Monitoring Visit or Close out visit as necessary (e.g. back-up or directly allocated to the site) if the CPM is compliant with local minimum requirements for monitoring.
Requirements:
Enthusiastic, knowledgeable and proactive
University degree in a scientific/life science field
At least 2/3+ years as a CPM in a CRO setting
In depth knowledge of ICH GCP principles
Able to carry out independently all the activities related to the monitoring of clinical trials
Good knowledge of Office Suite (Word, Excel, PowerPoint)
Organizational and problem-solving skills
Excellent written and verbal communication skills including good command of English language
