Head of Clinical Operation and Clinical Pharmacology
Job creation – Permanent contract – Full time position
Based in France
Reporting to the EVP, Clinical Development and Regulatory Affairs, you will head all clinical operation affairs worldwide for Poxel clinical activities. You will be responsible for all operational aspects of clinical trials as well as mentoring the clinical operation team.
Your main responsibilities are:
- Leading all the clinical trial's operational activities
- Managing clinical trials in accordance with project goals, SOPs, regulatory framework, ICH guidelines and GCP and ensure that the deliverables of these studies are achieved in terms of budget, timing, quality and compliance with the procedures in force, in order to use them for the registration dossiers of the products concerned with the health authorities,
- Defining the best way to monitor trials conducted abroad (EU, US and Asia),
- Structuring CRO selection process and start up activities,
- Working closely with legal and financial department to review contracts and budgets, allowing a rapid start of the trials,
- Working closely with CMC, data management, drug safety, medical, PK, QA and regulatory team to prepare and review all the critical documents and study tools,
- Acting as a referent for all operational aspects of these clinical studies between the provider and the sponsor (from start to finish),
- Establishing and meeting trial milestones e.g. ethics/IRB approval, site initiation, etc.,
- Ensuring accurate tracking and reporting of study metrics,
- Communicating clinical studies performance to Management and other departments as needed.
- Mentoring the clinical operation's team to structure and develop their expertise
- Supervising day-to-day operational activities of the team to ensure delivery of high-quality data while adhering to the study budget and timeline,
- Developing competencies in critical study-related and transversal supportive activities,
- Creating internal exchange to leverage each study team knowledge and experience,
- Structuring procedure for key steps in clinical trials to improve the selection, start-up, recruitment phases, data cleaning and database lock activities.
- Developing a strong understanding and knowledge of the CROs to support the clinical operation and development activities
- Develop metrics to evaluate CRO's activities,
- Develop an extensive knowledge of CROs to match Poxel requirement depending on the clinical phase and the disease area of a given clinical trial (CRO excellence).
- Supporting / developing in close collaboration with head of clinical development, new strategies in the field of clinical activities to improve the capabilities and pertinence of procedures in place.
- Developing vendor management processes to directly and rapidly contract with specific vendors,
- Developing new tools or new processes to improve the effectiveness of clinical operation activities (connected devices, risk base monitoring activities…),
- Developing a dedicated force for contract and budget critical review in close collaboration with the responsible departments to speed up the start-up activities,
- Developing or updating SOPs in close collaboration with QA department.
You have a diploma in Pharmacy and an excellent command of English (written and spoken).
You have at least 10 years’ professional experience in the pharmaceutical industry as Trial Manager and Clinical Operation Manager. A previous experience in a Sponsor company (pharmaceutical industry, biotech) would be an advantage as well as an experience in diabetes or cardiometabolic.
You have strong organizational and collaboration skills with ability to meet the deadlines. You are known for your strong communication and leadership skills.
You are independent, flexible, pro-active, self-motivated and passionate about Clinical Operations.
You are used to work in a rapidly changing and cross-cultural environment.
As part of our disability inclusion action plan, our company's hiring policy aims to improve the representation of employees with disabilities in its workforce.
Are you interested in this job offer? Do not hesitate to send your application to the following email address: email@example.com.
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