Senior Clinical Project Manager
- Experience Level
OPIS 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.
OPIS’s 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.
OPIS is the number one Italian CRO. It was founded in 1998 and it is now present throughout Europe.
We offer a great opportunity as Senior Clinical Project Manager to manage international clinical trials.
Some of what you will do:
- Coordinating and overseeing project activities
- Organizing project activities and evaluating timeframes
- Managing the administrative aspects of studies
- Managing study materials (re-supply/drug expiration/re-labelling of drugs, various materials)
- Managing the vendors involved in the study
- Reviewing and approving the Investigator’s Folder and Trial Master File prototype
- Verifying compliance with operating procedures
- Ensuring that the monitoring activities are conducted as per monitoring plan requirements
- Reviewing monitoring, remote monitoring, contact and telephone contact reports
- Sending regular updates to the Sponsor
- Ensuring that the enrolment curve is on track and take actions in case of under-performance
- Checking compliance with timeframes, quality and contractual requirements
- Updating/checking the Trial Master File of the studies (country) according to OPIS and/or Sponsor procedures
- Ensuring that the site TMF are checked by the monitoring team according to OPIS and/or Sponsor procedures
- Coordinating/participating in Investigator’s Meeting, Monitor’s Meeting and project meetings
- At least two years of work experience as Clinical Project Manager
- In depth knowledge of GCP and techniques for the monitoring of clinical trials
- Able to work independently and to manage the monitoring activities of CRAs
- Good knowledge of English
- Good planning, organization and problem-solving abilities
- Good communication and interpersonal skills
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.
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything.