Clinical Operations Manager H/F
il y a 3 semaines
Company Overview:
At EndoGene.Bio, we are dedicated to advancing precision medicine in women's health. Our mission is to significantly shorten the diagnosis time for endometriosis from years to mere weeks by utilizing proprietary biomarkers identified in menstrual blood.
We prioritize integrity over convenience, driven by scientific inquiry, boldness, and the belief that dedication and compassion are paramount. When challenges arise, we unite as a team, focusing on solutions. Our community is our strength, and we strive to uplift everyone involved in our mission, from patients to healthcare professionals and industry experts.
We are committed to fostering an environment where our employees can thrive and develop. Our diverse workforce is essential to creating a sense of belonging within the organization. We encourage you to take charge of your career, explore new opportunities, collaborate with colleagues, and pursue educational advancements. Your success is our collective success.
We are on a journey to establish a lasting impact 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 bringing our diagnostic innovations to market. This role necessitates close collaboration with patient advocacy organizations, interaction with medical professionals and hospital teams, formulation of clinical protocols, and management of sample acquisition. Your expertise will be vital to our organization's success and expansion.
Key Responsibilities:
Clinical Trials & Protocol Development:
Spearhead the creation and documentation of clinical protocols for our diagnostic solutions.
Supervise the execution of clinical studies and trials, ensuring compliance with timelines, budgets, and regulatory standards.
Track trial progress and identify potential challenges, implementing strategies to address these issues.
Hospital Engagement:
Foster robust relationships with key opinion leaders, healthcare providers, and hospital administration.
Recruit and onboard hospitals for clinical trials, ensuring they fulfill all research criteria.
Provide training and resources to hospital personnel involved in our studies and trials.
Patient Advocacy Collaboration:
Establish and maintain connections with significant patient advocacy groups focused on endometriosis.
Work alongside these organizations to ensure the patient perspective is prioritized in our clinical trials and product development.
Represent the company at patient advocacy events, conferences, and other relevant gatherings.
Sample Management:
Oversee the comprehensive process of sourcing, collecting, storing, and transporting diagnostic samples.
Ensure the highest quality and integrity of samples, adhering to all regulatory and ethical guidelines.
Coordinate with laboratories, storage facilities, and transport providers.
Cross-Functional Collaboration:
Collaborate closely with interdisciplinary teams including R&D, Regulatory Affairs, Quality Assurance, and Marketing to ensure alignment on project goals and deliverables.
Provide regular updates and presentations to senior leadership regarding the status 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 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 necessary.
Required languages: English, French, and Spanish.
Benefits:
Competitive compensation.
Comprehensive health benefits.
Company perks (if applicable): transport allowance, meal vouchers.
Opportunities for professional growth.
Collaborative and innovative workplace culture.
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