For our further dynamic and successful company growth we are looking for dedicated and well-experienced Clinical Project Manager to lead multicenter Early Phase PK/PD, Proof-of-Concept and dose finding trials.
You will manage multidisciplinary and multinational project teams to assure the accurate and timely completion of all contracted activities, designing and implementing project plans, acting as the primary liaison with the sponsoring company and communicating project information to appropriate staff members;
Planning, coordination and follow-up of the project after consultation with the sponsor, internal departments and external vendors or cooperation partners, if applicable, after completion of the Business Development activities and handover of the project;
Overall responsibility for timelines, budget and quality;
Coordination of preparation of study documents in cooperation with the respective departments;
Coordination of compilation and submission of study documents to ethics committees and regulatory authorities.
Master of Science (Life Sciences) or equivalent experience;
Experience in PK/PD, POC and multinational studies a plus;
Sound knowledge of relevant guidelines (e.g. ICH-GCP) and regulatory requirements;
Proven experience in budget tracking, vendor management, contracting, and project accounting internally and with partner organisations;
High proficiency with full MS Office Applications, including Excel and MS Project;
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade;
High level of competence in German and English language.
At least 5 years of experience in clinical research, with at least 3 years project management experience, preferentially in a CRO;
Certified Project Management professional and/or proven project delivery capabilities in trials Phase I-III.