Clinical Project Manager II

Clinical Project Manager II

CROMSOURCE

Home-based, Germany

As a Clinical Project Manager II, you will be responsible for managing the clinical projects and ensuring the quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines, and other applicable regulations.

Main Tasks and Responsibilities:

• Manage and coordinate the assigned clinical projects;
• Manage all project-specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.);
• Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members;
• Keep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned;
• Knowledgeable in the application process for clinical studies, in force in the country/ies of work;
• Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.);
• May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas;
• Assure the proper timelines of the assigned projects;
• Manage the budget for the project;
• Monitor the workload and the performance of the project team;
• Plan and monitor the tasks of the team in the specific areas;
• Coordinate the Clinical Research Associates and Clinical Monitors activity;
• Collaborate with Clinical Trial Administrators and Clinical Research Associates in terms of local authorities' approval activities;
• Collaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.);
• Collaborate with the CTAs in archiving activities;
• Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports;
• Deliver project-specific training;
• Organise and participate in Monitor and Investigator Meetings;
• Organise or take part in the periodic project update meetings;
• Provide project updates to the Sponsor, Senior Project Manager, and Project Director/Leader as required;
• Inform the Project Director/Leader about any issues;
• Perform co-monitoring visits for the assigned clinical projects as necessary;
• Act as a tutor for Project Coordinators and Project Managers I;
• Maintain relationships with the Sponsor, including providing project updates;
• Prepare the SOPs relating to clinical research activities in collaboration with the Quality System Unit;
• Collaborate in complying with enforcing Company procedures.

Education and Experience Required:

• University Degree in scientific, medical, or paramedical disciplines;
• Proven experience in clinical project management activities, 5 plus years in the CRO/pharmaceutical industry including previous experience as a CRA or similar;
• Excellent knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements;
• Fluent in English and local language(s);
• Proficiency in Microsoft Office (e.g., Word, Excel, Outlook);
• Willingness to travel.

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Germany      Clinical Research      Manager and Executive      Quality Assurance      CROMSOURCE