My client is a European clinical CRO providing premium support for the management of global clinical trials from phase I to IV as well as pre- and post-marketing medical device investigations.
Founded in 1998, the company has 20 years of extensive experience in a wide range of therapeutic areas. Its recent oncology/immuno-oncology portfolio amounts to over 400 trials.
Their strength lies in its people and its specialized teams who assist clients from A-Z with medical writing, scientific and statistical consultancy for trial design and skilled teams of operational staff across Europe that ensure high quality project execution.
The Senior 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.
The Senior Clinical Project Manager, under the supervision of the Clinical Operations Manager, carries out the following activities:
- 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)
- Prepare feasibility questionnaires (if applicable)
- Manage the vendors involved in the study
- 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 the company’s and/or Sponsor procedures
- Ensure that the site TMF are checked by the monitoring team according to the company’s 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
- Degree in a scientific field
- In depth knowledge of GCP and techniques for the monitoring of clinical trials
- At least two years of work experience as Clinical Project Manager
- Able to coordinate all the activities related to the management of local and international projects, monitoring of clinical trials, guaranteeing the security of information
- Reading: good Writing: good Speaking: good
- Able to work independently under the supervision of the Head of Clinical Operations Unit and Clinical Operations Manager
- Able to interact with personnel properly.
- Able to manage the monitoring activities of CRAs
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
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