(Associate) Clinical Trial Manager

HMNC Brain Health defines the future of depression and anxiety therapy. We develop innovative personalized therapies with the aim of shortening the time to improvement, improving therapy outcomes and reducing the risk of relapse. The core activities of our company are preclinical and clinical development as well as commercialization of innovative medications for depression and anxiety disorders and laboratory tests. With this unique approach of developing compounds together with accompanying biomarker tests, we can leverage the potential of our medications as targeted therapeutics for the patient groups who respond best.

And you can go the way with us. Join our team and define tomorrow’s treatment success as

(Associate) Clinical Trial Manager (m/w/d) - Fulltime

Location:

Job Summary:

The (Associate) Clinical Trial Manager will oversee the day-to-day operations of clinical trials with a focus on CRO and vendor oversight from study start-up to study closeout, patient enrolment, monitoring, compliance, and data flow and metrics from clinical sites. The successful candidate will work closely with cross-functional teams to ensure timely execution of clinical trials, adherence to protocol, and compliance with regulatory requirements.

Responsibilities:

• Oversee day-to-day clinical trial operations, including CRO and vendor oversight from study start-up to study closeout.
• Manage study timelines, budgets, and resources to ensure successful completion of clinical trials.
• Ensure that clinical trials are conducted in compliance with study protocols, ICH/GCP guidelines, and applicable regulatory requirements.
• Manage site selection, study start-up, enrolment, monitoring, and closeout activities.
• Conduct site visits and monitoring activities to ensure the quality of data collected, the safety of study participants, and compliance with the study protocol and regulatory requirements.
• Provide regular updates to the Vice President Clinical Operations and cross-functional teams regarding study status, issues, and risks.
• Contribute to the development of clinical trial documents, such as protocols, informed consent forms, and case report forms.
• Ensure that all clinical trial documentation is complete, accurate, and maintained in accordance with the company's SOPs and applicable regulatory requirements.
• Develop and maintain relationships with key stakeholders, including clinical investigators, study coordinators, and CROs/vendors.
• Assist with the preparation and conduct of regulatory inspections and audits.

Requirements / Professional Expertise:

• Bachelor's degree in life sciences, nursing, or related field required.
• 2+ years of relevant experience in clinical research, preferably in the pharmaceutical or biotech industry.
• Thorough understanding of ICH/GCP guidelines and applicable regulatory requirements.
• Experience in managing clinical trials from study start-up to closeout preferable.
• Experience in vendor and CRO management preferable.
• Excellent written and verbal communication skills.
• Strong organizational and project management skills.
• Ability to work independently and as part of a team.
• Flexibility to travel domestically and internationally, as required.

Why HMNC?

• An inspiring work environment in a young, motivated and international team with flat hierarchies.
• A permanent position with a competitive salary in an early stage, growing and dynamic company based in Munich.
• Multiple learning and development opportunities.
• A growing benefit portfolio including a yearly career development budget.
• Flexible and family-friendly working hours with the possibility of individual solutions.
• Good connection to public transportation as well as a parking garage in the office building.
• We value diversity – regardless of gender, nationality, ethnic and social origin, religion/belief, physical abilities, age as well as sexual orientation and identity.

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