Clinical Operations Associate Director
Il y a 6 mois
**Presentation of the company**:
AUROBAC THERAPEUTICS is a biopharmaceutical company created in 2022 by 3 renowned life sciences innovation companies, Boehringer Ingelheim, Evotec and bioMérieux, to become a global leader in the fight against bacterial infections, Antimicrobial Resistance (AMR) and their consequences in acute hospital settings such as Sepsis. We focus our efforts to develop the next generation of antimicrobial and acute care products, following a targeted precision medicine approach, i.e. associated with rapid diagnostics to support product use.
With strong growth ahead, within an international environment, the company is now looking for a Clinical Operations Associate Director, reporting to the company’s Chief Medical Officer.
**Description**:
**Missions**:
You will report to the CMO and work closely with the executive team to conduct your mission.
- Clinical Trial Operational Coordination:
- Co-ordinate and manage all activities inherent in the conduct of a clinical trial (phases I to III)
- Co-ordinate the generation and contribute to the development of trial-related documents, including informed consent forms, case report forms, and study manuals, in compliance with applicable regulatory requirements, guidelines, and standards in close collaboration with the Regulatory Affairs manager and the CMO
- Develop and maintain detailed project management tools, timelines, ensuring alignment with overall project goals.
- Proactively identify and address potential delays, implementing corrective actions as necessary.
- Manage functionally all study stakeholders, both internal (Clinical Operations team, Data-Manager, etc.) and external (CRO, etc.)
- Budget Oversight:
- Work closely with finance and project teams to develop and manage clinical trial budgets.
- Monitor and control expenses to ensure budget compliance.
- Site Selection and Management:
- Oversee the selection and initiation of clinical trial sites.
- Establish and maintain strong relationships with investigative sites, ensuring adherence to study protocols and timelines.
- Prepare documents and organize investigator meetings
- Vendor Management:
- Select and manage external vendors, including Contract Research Organizations (CROs), central labs, and other service providers.
- Ensure vendor performance by very close monitoring and adherence to quality standards.
- Data Management and Committees coordination
- Collaborate with data management teams to ensure accurate and timely data collection and reporting.
- Supervise development of data collection tools and database design, in liaison with the Data Manager and in line with the protocol
- Oversee data cleaning and validation activities.
- Supervise statistical analysis and interpretation of results, in liaison with the statistician
- Supervise/coordinate committees involved in studies (e.g., DSMB, adjudication committees), in close collaboration with the CMO
- Risk Management:
- Identify potential risks and develop risk mitigation strategies.
- Proactively address issues to minimize impact on the trial.
- Communication and Reporting:
- Facilitate regular project team meetings to ensure effective communication and collaboration.
- Prepare and present project updates to internal and external stakeholders.
- Clinical Operations-related Quality Assurance and Compliance:
- Implement and maintain quality assurance processes to ensure compliance with Good Clinical Practice (GCP) guidelines and the company’s Quality Management System
- Implement and maintain processes to ensure compliance with data protection regulations (e.g., GDPR, HIPAA) in the regions of trial execution as well as future submission of the data.
- Supervise the filing and archiving of all study documents for audit or inspection purposes
- Conduct internal audits and oversee external audits, as required.
- Participate in audits and/or inspections, as well as in preventive/corrective actions in the event of quality problems within the framework of the clinical study.
**Personal skills**:
- Fluency in English is a must-have, French language skills would be a major plus.
- Proven expertise in international clinical trial management
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
- Detail-oriented with strong organizational and project management skills.
- Analytical and synthetic skills.
- Excellent communication, negotiation, and interpersonal skills.
- Proven ability to work collaboratively in a fast-paced, cross-functional environment.
- A forward-thinking individual who thrives in a dynamic and entrepreneurial environment.
**Professional experience**:
- Educational Background: A double cursus with an Advanced degree (PharmD, Ms, Engineering or PhD) in biotechnology or pharmaceutical sciences.
- Experience: 7 to 10 years of experience in a similar role within the biotech or pharmaceutical industry, in clinical trial management, including Phase II-III trials.
- Used to working in an
-
Clinical Research Associate
Il y a 7 mois
Lyon, France EastHORN Clinical Services Temps plein**Job summary**: As a **Clinical Research Associate **you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaison with vendors and other duties....
-
Clinical Operation Manager
Il y a 5 mois
Lyon, France EastHORN Clinical Services Temps plein**Job summary**: As an experienced **Clinical Operations Manager **you will be expected to develop and grow the team in France and support clients relationships for the assigned region. Reporting to the Executive Director Clinical Operations, you will be a key member of the **Clinical Operations team.** We are searching for an experienced, ambitious and...
-
Director of Clinical Operations
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Resourcing Life Science Temps pleinJob OverviewWe are seeking a highly experienced Director of Clinical Operations to lead cross-functional project teams globally for assigned studies in the start-up phase. The ideal candidate will assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.Key ResponsibilitiesMonitor study timelines, patient...
-
Clinical Research Associate Ii
Il y a 7 mois
Lyon, France ICON plc Temps plein**As a Clinical Research Associate** you will be dedicated to one of our global pharmaceutical clients; with whom ICON shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market. Leading by example, you can set the standard of excellence and enjoy a challenging career in our exclusive programs. **We are...
-
Clinical Research Associate
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Pharmiweb Temps pleinJob Title: Clinical Research Associate - Pharmaceutical IndustryJob Summary: We are seeking a highly motivated and experienced Clinical Research Associate to join our team in the pharmaceutical industry.Key Responsibilities:* Conduct site visits and manage investigator sites for assigned studies* Develop effective relationships with investigator site staff...
-
Senior Clinical Research Associate
Il y a 5 mois
Lyon, France Proclinical Temps pleinProclinical are recruiting for a Senior Clinical Research Associate for a CRO. This role is on a permanent basis and is located in France. *** **Responsibilities**: - Perform qualification, initiation, supervision and close-out visits for research sites in compliance with the approved protocol. - Guarantee GDP are being adhered to and discussing protocol...
-
Clinical Research Associate
il y a 2 semaines
Lyon, Auvergne-Rhône-Alpes, France Pharmiweb Temps pleinInHouse Clinical Research Associate - An opportunity to shape the future of clinical development with ICON plc, a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment driving innovation and excellence. Key Responsibilities: Support the execution and management of clinical trialsConduct site feasibility...
-
Clinical Sales Development Associate
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Intuitive Temps pleinJob Description: As a Clinical Territory Associate at Intuitive, you will play a critical role in developing and executing sales strategies to drive growth and adoption of our da Vinci Surgical Systems. You will work closely with the Clinical Sales Manager to gain a deep understanding of our business, including technical, clinical, and sales aspects.Key...
-
Sales Associate
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Intuitive Temps pleinJob Summary: We are seeking a highly motivated and detail-oriented Clinical Territory Associate to join our team at Intuitive. The successful candidate will work closely with the Clinical Sales Manager to gain knowledge in all aspects of our business, including technical, clinical, and sales.Key Responsibilities:Train to be a da Vinci Surgery technical and...
-
Clinical Territory Associate
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Intuitive Temps pleinJob SummaryThe Clinical Territory Associate will work closely with the Clinical Sales Manager to develop surgical robotics programs in the assigned territory. This role requires a high level of commitment and involves training to be a da Vinci Surgery technical and sales expert across all primary surgical specialties.Key Responsibilities:Provide technical...
-
Clinical Research Associate
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Pharmiweb Temps pleinJob SummaryWe are seeking a highly motivated Clinical Research Associate to join our team in France. As a CRA, you will be responsible for managing investigator sites for assigned studies, planning and conducting site visits, and developing effective relationships with site staff.Key Responsibilities:Full ownership of investigator sites for assigned...
-
Clinical Territory Associate
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Intuitive Surgical Temps pleinCompany OverviewAt Intuitive Surgical, we are driven by a mission to advance minimally invasive care through innovative technology and collaboration with healthcare professionals. Our team is committed to fostering an inclusive and diverse environment where great ideas can thrive.We are seeking a Clinical Territory Associate to join our team and contribute...
-
Clinical Territory Associate
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Intuitive Surgical Temps pleinJob SummaryWe are seeking a highly motivated Clinical Territory Associate to join our team at Intuitive Surgical. As a key member of our sales and support team, you will work closely with our Clinical Sales Manager to develop and execute strategies to maximize the utilization of our da Vinci Surgical Systems in assigned territories.Your primary function will...
-
Clinical Territory Associate
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Intuitive Temps pleinAbout the RoleThe Clinical Territory Associate will work closely with the Clinical Sales Manager to gain knowledge in all aspects of our business, including technical, clinical, and sales. This role is a developmental position that requires high commitment and a strong work ethic.Key ResponsibilitiesProvide guidance and training to surgical teams on the use...
-
Clinical Territory Associate
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Intuitive Temps pleinAbout IntuitiveWe are a pioneering company in robotic-assisted surgery, dedicated to expanding the potential of physicians to heal without constraints. Our mission is to make minimally invasive care a reality for patients worldwide.Job DescriptionThe Clinical Territory Associate will work closely with the Clinical Sales Manager to develop surgical robotics...
-
Clinical Research Associate II in Oncology
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Pharmiweb Temps pleinJob SummaryWe are seeking a highly skilled Clinical Research Associate II in Oncology to join our team. As a key member of our clinical development team, you will be responsible for ensuring the successful execution of clinical trials in oncology.Key Responsibilities:Perform site qualification, site initiation, interim monitoring, site management activities,...
-
Clinical Territory Representative
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Intuitive Temps pleinWe are seeking a highly skilled Clinical Territory Associate to join our team at Intuitive.The successful candidate will work closely with the Clinical Sales Manager to gain a deep understanding of our business, including technical, clinical, and sales aspects.Key Responsibilities:Technical and Clinical Expertise: Develop surgical robotics programs in the...
-
Clinical Territory Associate
Il y a 2 mois
Lyon, France Intuitive Surgical Temps pleinCompany DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team,...
-
Clinical Territory Associate
Il y a 2 mois
Lyon, France Intuitive Temps pleinCompany Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse...
-
Clinical Territory Associate
il y a 4 semaines
Lyon, Auvergne-Rhône-Alpes, France Intuitive Temps pleinAbout IntuitiveWe are a pioneering company in robotic-assisted surgery, committed to making a difference in the world of minimally invasive care. Our mission is to expand the potential of physicians to heal without constraints, and we strive to foster an inclusive and diverse team to help us achieve this goal.Job DescriptionThe Clinical Territory Associate...
