Senior Clinical Project Manager (Munich or EU Remote)

Siegfriedstraße 8
negotiable Expired 8 months ago
This job has expired.

JOB DETAIL

Kaia is a mission-focused health technology company.
Our story began in 2016, when our founders Konstantin Mehl and Manuel Thurner, set out on a mission to bring affordable and accessible relief to millions of people with chronic conditions.  No strangers to chronic pain themselves, they decided to innovate ways to remove the obstacles many people experience in getting the leading-edge care they need in order to live their best lives.
How do Kaia apps work? Kaia uses a dynamic AI-powered algorithm. Our programs are based on multimodal rehabilitation, a holistic approach to managing chronic conditions. Our users have easy access via smartphone and tablet to our programs for back/hip/knee pain and COPD using this evidence-based approach.
Five years into our story, we are a leader in digital therapeutics, with 500,000+ users worldwide. Having raised $125 million from investors such as Optum Ventures, idInvest, and Balderton Capital. We are poised to create a global footprint in digital self-care; Kaia is patient empowerment made easy.
The regulatory landscape is quickly adapting to the digital ecosystem. Therefore, our mission and strategy bring new opportunities for exceptional talent to join our journey. With over 150 “Kaianeers” spread across the globe, we need now, more than ever, specialized talent to help take our mission further.
The Senior Clinical Project Manager will be responsible for the general management of clinical trials of medical device studies and real-world evidence projects involving digital health applications.
Location: Germany-Remote (Preferred), or Europe Remote

The key responsibilities include:

    • Take ownership of all aspects of project management and project administration throughout the entire project lifecycle for national and international clinical trials of medical devices, national and international investigator-initiated trials (IITs) and government-funded research projects, all involving digital health applications.
    • Provide project management oversight for clinical trials of medical devices outsourced to clinical research organizations (CROs).
    • Plan and manage real-world evidence and health-economics-outcome related projects as well as device-related feasibility studies.
    • Plan and conduct study start-up, site maintenance and study close-out activities. This includes planning and executing submissions to ethics committees and regulatory bodies.
    • Develop, author, edit and review clinical trial related documentation, e.g., clinical investigation plans, monitoring plans, statistical analysis plans, final study reports, handbooks, guidelines, checklists).
    • Manage clinical trial documentation and essential documents including the trial master file (TMF).
    • Develop Investigator Site Files.
    • Liaise and collaborate closely with other clinical functions, e.g., statistics, data management, service vendors or CROs as applicable.
    • Create and maintain clinical trial budgets and provide regular financial updates on assigned trials.
    • Provide support and guidance to the infield CRAs in the conduct, execution and follow-up of site selection, site initiation, interim monitoring, and close-out visits in accordance with ICH-GCP regulations, ISO 14155, other applicable regulations, and sponsor standard operating procedures (SOPs). This includes review and approval of monitoring visit reports.
    • Be the first point of contact for study-related questions and issues for the infield CRAs and any project-related escalations received.
    • Prepare and participate in Investigator’s Meetings. Lead project-specific regular update calls.
    • Mentor and support junior clinical project managers.

What you will bring to the team:

    • BA/BS degree in science/healthcare field, nursing degree, or equivalent combination of education and work experience.
    • Fluid oral and written communication in German and English (a third language is a plus).
    • Demonstrated ability to own and execute clinical study projects in a GCP regulated environment for medicinal drugs or medical devices.
    • Previous experience of at least 2 years in a (Senior) Clinical Project Manager position in a CRO or with a sponsor.
    • Excellent knowledge of ICH-GCP, applicable laws and regulations, monitoring procedures, and thorough understanding of the clinical trial process.
    • Excellent communication and interpersonal skills.
    • Advanced computer skills and readiness to work with new technologies.
    • Flexibility, as well as the ability to work independently to coordinate all necessary activities required throughout the study lifecycle, starting from set up, feasibility and site selection to study conduct including monitoring and project close-out.
    • Sound understanding of clinical trial budgeting and finances.
    • Curiosity and willingness to work in the new and rapidly evolving field of digital therapeutics, and to translate knowledge from prior roles into a pragmatic working style in a rapidly changing environment.
    • Profound understanding of the international laws and regulations for medical device trials is a plus.
Some of the benefits of being a Kaianeer:
You can directly influence the future of digital health in a team of industry experts and digital shapers.
You will work alongside serial entrepreneurs (previously founded and scaled another startup, Foodora).
You’ll enjoy accessible leaders, a hybrid (home/office) or remote work environment, and flexible vacation and working times.
We support your professional development and have a budget and PTO set aside for you just for that!
Happy hours, team events, and knowledge-sharing sessions.
Join us if you’re looking for an entrepreneurial adventure and an exciting place to grow personally and professionally.

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