Geneva, Switzerland
1 day ago
Project Manager in Clinical Research [F/M/X]
Who are we? Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:   

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you! 

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.   

As you know, every person is different and so is every role in a company.  That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience. 
We look forward to meeting you!

Job description Job description

Join our team and play a key role in the successful execution of clinical trials within the Clinical R&D department. As a Senior Clinical Research Specialist, you will be responsible for overseeing various aspects of clinical trial operations, ensuring compliance with industry regulations, and fostering strong relationships with internal and external stakeholders.

Your missions Manage feasibility, site selection, setup, execution, and closure of clinical trials in compliance with ICH-GCP, regulatory requirements, and company SOPs. Act as the primary point of contact for clinical trial sites, ensuring smooth communication and site management. Contribute to the development of essential trial documents, including protocols, informed consent forms, case report forms (CRF), and study manuals. Support clinical trial registration and publication processes, ensuring accurate and timely dissemination of study results. Oversee the ordering, tracking, and accountability of investigational devices and trial materials. Coordinate with site personnel, ethics committees, vendors, and internal teams to ensure effective trial execution. Supervise and collaborate with Clinical Research Associates (CRAs) for optimal site monitoring and compliance. Manage the development and execution of investigator agreements and trial-related payments. Conduct clinical data reviews to ensure data integrity and readiness for statistical analysis. Perform monitoring activities, including site qualification, initiation, interim monitoring, and close-out visits as required. Contribute to the development of global evidence generation and dissemination strategies. Provide on-site protocol compliance and data collection support when needed. Assist in post-market clinical follow-up (PMCF) planning and reporting. Support project budgeting activities and ensure compliance with financial guidelines. Mentor junior team members and contribute to process improvements within the department. Your profile Educational background: Bachelor’s degree (minimum) in Life Sciences, Physical Sciences, Nursing, or Biological Sciences. Experience: BS with at least 4 years, MS with at least 3 years, or PhD with at least 2 years of relevant experience in clinical research. Prior experience in clinical research or equivalent is required. Medical device industry experience is highly preferred. Technical competencies: Strong knowledge of clinical research processes, trends, and global trial regulations. Proven ability to support clinical project delivery on time, within budget, and in compliance with regulatory standards. Proficiency in technical writing and presentation skills. Excellent written and verbal communication in English. Leadership skills: Ability to lead study teams to achieve key milestones. Strategic mindset with the ability to develop and implement process improvements. Strong problem-solving and decision-making abilities. What we offer A collaborative and dynamic work environment that values innovation and expertise. Opportunities for professional growth and career advancement. Engagement in impactful clinical research projects with industry-leading professionals. Exposure to global clinical trial operations and best practices.

We are committed to fostering an inclusive and diverse workplace. We welcome applications from all qualified individuals regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or any other characteristic.

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