Senior Lead International Clinical Trial Managers, Trial Management, Clinical R&D
Trial Management is responsible for planning and execution of clinical trials in phase 2 to 4 within all therapeutic areas in Ferring. High quality trial data and adherence to timelines are important for us. To optimize the achievement of this a good and constructive teamwork and strong leadership abilities in accordance with our values are critical success factors. We have many exiting clinical trial going on and are hence looking to expand the department.
You will be responsible for the delivery of an agreed trial as defined in the trial outline/protocol and operational plan, to the agreed quality, budget and timelines together with clinical operations members and clinical team members. You may have a main role in larger programs involving several regions with high complexity and/or high company priority.
Your essential tasks will be:
- Collaboration with the Clinical Project Leader and lead the clinical trial team and coordinate and manage all activities related to clinical trials through the clinical trial team
- CRO selection process and communication of expectations to be met by the CRO. Give input to and review CRO contract with respect to tasks, budget, timelines
- Liaison with clinical trial team members regarding trial design and protocol preparation and ensure the production of the final trial protocol
- Development of operational plan and risk management plan for the conduct of the clinical trial
- Develop sponsor oversight plan and carry out Day to day responsibility of the CROs on the given studies
- Planning, delivery and conduct of all clinical trial activities (start-up, operational conduct and closure)
- Communicate timelines, identify milestones, handle trial budget and report progress for the clinical trials
- Facilitator in start-up of trials to other clinical TM teams if applicable
- Mentoring and training of CTMs using a training plan endorsed by the Line Manager
We expect you to have a university degree within medicine or life sciences, extensive experience within clinical drug development and preferably at least 7 years’ experience in managing clinical trials (phase 1 or phase 2/3, as applicable). You have GCP certification and experience with multi-country and multi-center studies.
The successful candidate is bright, ambitious with an easy yet assertive personality. We expect you to be a true team player but also to be able to work independently on your own tasks.
You will need to be detail oriented with high quality standards. In addition, it is essential that you are well organized, pro-active and flexible with the ability to work on multiple tasks in a multicultural environment.
Excellent knowledge of MS Office and fluency in English with good verbal and written communication skills is a given.
For additional information, please contact Associate Director Cecilia Hemert, phone +45 28787506 or Director Klas Rådberg, phone +4528787508. Please send your application and CV in English via the application button as soon as possible but no later than 25th September 2016 as we will review incoming applications on an ongoing basis.