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Clinical Operations Manager H/F

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Company Overview:

At EndoGene.Bio, we are dedicated to advancing precision medicine in women's health. Our mission is to significantly shorten the diagnosis timeline for endometriosis from years to mere weeks through innovative biomarkers identified in menstrual blood.

We prioritize integrity over convenience, driven by scientific rigor and a commitment to hard work and compassion. When challenges arise, we collaborate as a team, striving to empower everyone involved in our mission—from patients to healthcare professionals and industry advisors. Our community is our strength.

We are committed to fostering a workplace where our employees can thrive and evolve. Embracing diversity, we aim to create an inclusive environment where everyone feels a sense of belonging. We encourage you to take charge of your career, explore new opportunities, and pursue professional development. Your success is our collective success.

We are on a journey to establish a legacy in women's health, and we invite you to be part of it.

Position Overview:

As a Clinical Manager at EndoGene.Bio, you will be instrumental in propelling our diagnostic solutions into the market. This role involves close collaboration with patient advocacy organizations, engaging with healthcare providers and hospital teams, developing clinical protocols, and managing sample procurement. Your expertise will be vital to our organization's success and expansion.

Key Responsibilities:

Clinical Trials & Protocols:

- Spearhead the creation and documentation of clinical protocols for our diagnostic offerings.
- Oversee the execution of clinical studies and trials, ensuring compliance with timelines, budgets, and regulatory standards.
- Track trial progress and identify potential challenges, implementing risk mitigation strategies as necessary.

Hospital Recruitment:

- Foster strong relationships with key opinion leaders, physicians, and hospital administrative personnel.
- Recruit and onboard hospitals for clinical trials, ensuring adherence to research criteria.
- Provide training and resources to hospital teams involved in our studies and trials.

Patient Advocacy Engagement:

- Establish and maintain connections with key patient advocacy groups focused on endometriosis.
- Collaborate with these organizations to ensure the patient perspective is integral to our clinical trials and product development.
- Represent the company at patient advocacy events, conferences, and relevant forums.

Sample Sourcing Activities:

- Manage the comprehensive process of sourcing, collecting, storing, and transporting diagnostic samples.
- Ensure the highest quality and integrity of samples, complying with all regulatory and ethical standards.
- Coordinate with laboratories, storage facilities, and transportation services.

Team Collaboration:

- Collaborate closely with cross-functional teams, including R&D, Regulatory, Quality Assurance, and Marketing, to ensure alignment on project goals and deliverables.
- Provide regular updates and presentations to senior management regarding the progress of clinical initiatives.

Qualifications:

- Medical Doctor (MD) degree or equivalent qualifications with experience in clinical studies in IVD.
- Preferred experience in Gynaecology.
- Background in clinical research or clinical project management, ideally related to diagnostics and gynaecological conditions.
- Familiarity with regulatory guidelines and ethical considerations in in-vitro diagnostic research.
- Exceptional interpersonal and communication skills, both written and verbal.
- Willingness to travel as required.
- Required languages: English, French, and Spanish.

Location:

Candidates must be based in France or Spain.

Benefits:

- Competitive salary.
- Comprehensive health benefits.
- Company perks (if on site): transport ticket, meal tickets.
- Opportunities for professional development.
- Collaborative and innovative work environment.