CLINICAL RESEARCH PHYSICIAN F/M

Missions

Reporting to the Medical Director, the Clinical Research Physician F/M develops and drafts study protocols, presents them to the various internal and external stakeholders and is the medical referent on its projects.

The position is based in Paris or in Montpellier.

Main Activities

o Responsibility and monitoring of clinical activities:

o Participate in regulatory submissions and discussions with health authorities / ethics committee in conjunction with the regulatory department;

o Review or drafting of supporting documents for the clinical study (protocol, investigator brochure and inform consent form, case report form and patient diary, etc.);

o Review and validation of clinical data during the study and coordination of data analysis;

o Control of the progress of clinical studies;

o Management of subcontracting activities related to the production of clinical study reports;

o Control and validation of clinical study reports and publications of clinical study results;

o Responsible of the quality of clinical documents according to international standards and internal procedures

o Establishment and animation of networks of investigators and opinion leaders;

o Presentation of clinical development projects to health authorities, investigators, opinion leaders and congresses;

o Review and follow-up of adverse events, review of narratives (initial/follow-up), write or review annual safety reports

Profile

- Diploma:

o State Diploma of Doctor of Medicine or PhD or equivalent

- Prior Experience:

o At least 5 years of experience in a similar position

o Significant experience in a health industry: biotech, pharmaceutical industry, health industry provider, etc.

o Expertise in a rare disease and/or in gene therapy would be a plus

- Tongues:

o Fluent in French & English

- Crossfunctional skills:

o Have operational and fluent English

o Be comfortable and effective in communication, while being diplomatic

o Work as a team and cross-functionally ((R&D, Regulatory Affairs, Quality, Legal, Marketing and Finance)

o Have writing skills and a capacity for analysis and synthesis

o Be rigorous, autonomous and dynamic

o Have a keen sense of listening and communication

o Be flexible, adaptable and flexible

o Have ethics (respect for the patient and the confidentiality of this data)

o Comply with company policy

- Business skills:

o Have a methodological approach to clinical studies, analysis, use of study results, statistical processing and bibliographic research

o Have medical knowledge, clinical trial procedures and good clinical practices

o Know the guidelines and regulatory references in medical writing (clinical and regulatory documentation)

o Know how to write clinical study reports and scientific publications according to regulatory standards

o Analyze, interpret and synthesize data from pre-clinical / clinical studies

o Proficiency in MS Word, Excel, Powerpoint and Adobe Acrobat Professional

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STAY ALERT !

Several incidents involving organizations and individuals claiming to be fraudulently recruiting on behalf of Sensorion have recently been identified.

The objective of the fraudsters is to extort money from applicants by requesting additional expenses (medical devices, travel agency, visa fees, etc.) or obtaining personal data (bank details, address, etc.). Please note that Sensorion, its subsidiaries or the recruitment firms they appoint during the hiring process do not request financial contributions or bank details from candidates under any circumstances.

We take this situation very seriously and are taking all possible actions to identify and put an end to this type of fraud.

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