Clinical Project Manager

Highly Competitive
  1. Permanent
  2. Project/Study Manager (CSM/CPM)
  3. Germany
Frankfurt am Main, Germany
Posting date: 15 Feb 2021
35704

Proclinical has partnered with a well-established CRO who are looking for a Clinical Project Manager to join their growing team. You will be responsible for overseeing clinical studies in Germany where you will manage also manage vendors. There is a lot of opportunity to take on a range of responsibilities whilst working in an autonomous and driven environment.

Job Responsibilities

  • Manage national and/or multinational clinical trials with innovative vaccines in the field of oncology/infectious diseases in close interaction with Contract Research Organizations (CROs)
  • Manage the budget, resources, and timelines associated with all study activities, including CRO/investigator agreements and other contractual agreements
  • Lead project teams through the start-up, study conduct, and report writing of clinical studies
  • Supervise the CRO and perform co-monitoring visits
  • Build up good working relationships with clinical sites
  • Ensure the appropriate development of all documents internally and by the CROs, including study protocols, informed consent forms, case report forms and instructions, and other project-specific documents required for the conduct of assigned studies
  • Manage the preparation, handling, distribution, filing and archiving of clinical documentation and reports. This also includes the periodic review of study files for accuracy and completeness
  • Develop, write, and implement processes, systems, and Standard Operating Procedures (SOPs), to ensure quality and compliance with GCP and regulatory requirements

Skills and Requirements

  • Several years of professional experience in clinical research at either a CRO, pharmaceutical, or biotech company
  • Understanding of the current national and international laws and guidelines regarding the conduct of clinical trials, specifically with ICH-GCP
  • Project Management Experience
  • Systematically perform activities in a timely and accurate manner
  • Service oriented approach; flexible and proactive attitude towards changing needs
  • Very good knowledge of MS Office Suite and MS Project
  • Fluency in English and German

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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