Description

Clinical Trial Manager, home-based, sponsor dedicated

Here at Syneos Health we are currently recruiting for a local Clinical Trial Manager to be home-based from anywhere in Germany, and work on a sponsor-dedicated role for one the world's leading Pharmaceutical companies. The role is part of our FSP 360 team (functional service provider), which is designed to successfully meet the individual needs and goals of the client you will be supporting. You will be working on international trials, and your responsibility will be local, namely for Germany.

JOB RESPONSIBILITIES

Project Leadership and Delivery:

• Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements.
• Is directly responsible in the Customer's team to ensure project launch, conduct, and closeout according to the Customer's and the Company's contractual agreement.
• Leads clinical team to ensure quality, timelines and budget management.

Reporting and Communication:

• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
• Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files.
• Provides oversight for development and implementation of project plans in accordance with Controlled Documents.
• Independently prepares, coordinates, and presents project material at internal and external meetings.
• Prepares project management reports for management.
• Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goals.

Management:

• May train and support new Project Managers. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training.

Qualifications

What we're looking for

• Min Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience is mandatory, but higher degrees (MSc/PhD are preferred)
• Prior experience in leading neurology (MS), rare diseases, respiratory, dermatology interventional trials independently, end to end, as a CTM across Germany, Austria and Switzerland is required
• Excellent communication, presentation, interpersonal skills, both written and spoken.
• Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment.
• Fluency in German and English language is mandatory

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.