Description:
Location: Home Based - The Netherlands

Schedule: Permanent, Full-time

Do you want to join a team that is passionate about making a difference in drug and medical device development? CROMSOURCE, a growing CRO, is recruiting for a dynamic person to join our in-house team. You will work on projects from our varied client base, ranging form small to mid-sized pharma and medical device companies.

As a Clinical Project Manager you will be responsible for oversight of assigned clinical projects ensuring quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines and other applicable regulations. You may also act as Project Leader and as Clinical Team Leader in stand-alone monitoring/start-up projects.

Main Tasks and Responsibilities

• Manage and coordinate the assigned clinical projects
• Manage all project specific services required by the Sponsors (centralised lab exams, drug shipments, document shipments, etc.)
• Manage the correct development of the clinical project, interact with the Sponsor and the Investigators and properly coordinate 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.
• May act as Technical Specialist supervising the projects within specific therapeutic/technical areas
• Assure the proper timelines of the assigned projects
• Manage the budget of the projects
• Monitor the workload and the performance of the project team
• Plan and monitor the tasks of the team in the specific areas
• Coordinate Clinical Research Associates and Clinical Monitors activities, ensuring compliance with ICH-GCP guidelines and applicable laws and regulations
• Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities
• Collaborate with the Clinical Trial Administrators in archiving 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.)
• Assist the Medical Monitor in preparing protocols, Case Report Forms and final Clinical Study Reports
• Deliver project specific trainings
• Organise and participate in Monitor's and Investigator's Meetings
• Organise and/or take part in the periodic project update meetings
• Provide project updates to the Sponsor, Senior Project Manager and/or Project Director/Leader
• Inform the Project Director/Leader about any issues
• Perform, if necessary, co-monitoring visits for the assigned clinical projects
• Carry out the monitoring of the sites for the assigned projects, where applicable
• Act as mentor for Project Coordinators and Junior Project Managers
• May act as Feasibility Associate after appropriate and documented training
• Keep contact with the Sponsor to verify the consistency with contract requirements and Sponsor satisfaction
• Prepare the SOPs relating to clinical research activities in collaboration with the Quality System Unit
• Collaborate in complying and enforcing Company procedures

Education and Experience Required

• University Degree in scientific, medical or paramedical disciplines
• Significant experience in clinical project management in the CRO/pharmaceutical industry
• 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

The Application Process

Once you have submitted your CV, you will receive an acknowledgement email. If you have the requirements we need, you will be invited for phone interview as the first step.

If you would like to discuss the role before applying through the website @ www.cromsource.com/careers/job-vacancies please contact careers@cromsource.com for more information.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Senior Project Manager, Clinical Project Manager, Clinical Study Manager, Study Manager, Project Manager, Clinical Trial Manager, Trial Manager, Research Manager, CRO, Clinical Research Organisation, Contract Research Organisation, Clinical, Drugs, Medical Devices, Medical Device, Project Management, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, The Netherlands, NL

Skills: Clinical Project Manager Location: Netherlands Share:

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