Clinical Project Manager
Aktiia, Switzerland
Job Description
Aktiia was founded out of a passion to create the best solution for the diagnosis and management of hypertension.
We are a venture-backed startup that recently closed a new financing round. Our technology is based on (15+) years of research by our founders at the prestigious Swiss research institution, CSEM. Aktiia's solution has been validated through extensive trials in acute and low-acute settings, with its accuracy receiving worldwide acknowledgment from medical and scientific experts. The Aktiia team (45 employees) is smart and driven, with colleagues who are all focused on bringing to market an innovative and impactful solution.
To strengthen our clinical team, we are looking for a:
CLINICAL PROJECT MANAGER
to start at the earliest convenience (100% position) in Switzerland or the UK.
Job Overview
We are seeking an experienced and highly motivated Clinical Project Manager to lead and execute large-scale clinical studies and projects. The successful candidate will be responsible for overseeing all aspects of clinical project management, including study planning and preparation, submission, execution, and logistical operations. Reporting to and collaborating with the Clinical Operations Manager and the Chief Medical Officer, the Clinical Project Manager will play a pivotal role in ensuring the successful completion of clinical projects and trials, adhering to regulatory guidelines, and maintaining the highest standards of quality.
Responsibilities:
- Develop and implement comprehensive project plans, timelines, and milestones for large-scale clinical studies and data-gathering projects.
- Manage all aspects of clinical trials, including preparation of all study documentation, regulatory submissions to competent authorities and ethics committees, site selection, recruitment progress, and monitoring activities.
- Monitor and track project progress to ensure successful conduct of clinical studies, identifying potential risks and developing mitigation strategies.
-Conduct training and regular project team meetings to keep all stakeholders informed and aligned.
- Collaborate with data management teams to design and maintain electronic data capture systems and high quality clinical databases.
- Collaborate with cross-functional teams to ensure alignment of project goals with organizational objectives.
- Ensure compliance with good clinical practice and other regulatory requirements throughout the entire clinical projects.
- Collaborate with clinical investigators, study coordinators, and other stakeholders to facilitate smooth study conduct.
- Create compelling visual materials and reports to be shared with Investigators and Aktiia personnel.
- Coordinate logistical aspects of clinical operations, including device supply management, central laboratory services, and other study-related services.
- Manage budget and resource allocation for clinical projects.
Requirements
- Minimum bachelor's degree (preferably in the life sciences or other relevant field)
- Minimum 3-5 years' experience as a Clinical Project Manager, with a track record of successfully managing small and large-scale clinical studies within medical device, healthcare or pharmaceutical industries (previous experience within a CRO a plus).
- Working understanding of clinical trial regulations and guidelines (ICH-GCP, FDA, EMA).
- Experience and skill with Microsoft Suite of tools.
- Expertise with Electronic Data Capture (EDC) tools.
- Comfort working in a dynamic, creative, research-oriented group
- Experience in managing several ongoing concurrent projects at any one time.
- Excellent organizational and communication skills.
- Effective interpersonal and relationship-building skills, with experience amp; success working cross functionally with clinical, data management, technology, commercial and other relevant teams
- Proficient in project management tools and software.
- Ability to speak French is a plus.
- Preferably based in UK or Switzerland.
Benefits
- Competitive salary and benefits package.
- Ability to work remotely, with limited travel.
- Opportunity for professional development and advancement.
- Collaborative and dynamic work environment.