To expand the international team we are looking for a Clinical Project Manager in Germany.
The Clinical Project Manager (CPM) is responsible for the management of all aspects of Clinical Trial Team activities for assigned project(s). The CPM, in collaboration with the Director Clinical Operations (DCO), is accountable for achieving successful delivery of the Siron Clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.
Your responsibilities will include:
- Proactively manage on a project level complex multi-center clinical research projects
- Provide updates on trial progress to the Director of Clinical Operations (DCO) with respect to project plans, trial budget and timeline management, quality standards and risk mitigation.
- Delivery of clinical research projects on time, within budget and in accordance with high quality standards
- Lead the study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
- Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
- Ensure potential study risks are escalated to the attention of the DCO when appropriate. Training, mentoring and coaching team members
- Review and approve site visit reports; ensure tracking, follow up and timely resolution of site issues.
- Being the primary point of contact to client on all project matters
- Attending bid defense meetings, participating in development of proposals and client presentations
- Other duties as assigned
- University or HBO degree, preferably in science or health related discipline;
- 10 years of experience in clinical research with increasing levels of responsibility;
- At least 1-2 years of project management experience;
Therapeutic experience (preferred) in oncology, cardiology and/or rare disease indications;
- Full working proficiency in English;
- Proficiency in MS Office applications, including MS Project/ PC skills to be able to work with MS Word, Excel, PowerPoint and MS Project;
- Excellent communication, presentation and customer-service skills;
- Ability to negotiate and build relationships at all levels;
- Team-building and organizational skills.
If this position sounds like the next step in your career, please send us your CV and a motivational cover letter via email.