Senior Cra/cra Ii

Il y a 2 mois

RueilMalmaison, France Labcorp Temps plein

Clear and confident health care decisions begin with questions. At Labcorp, we’re constantly in pursuit of answers. With unparalleled diagnostics and drug development capabilities, we accelerate innovation and provide insight to improve health and improve lives. Whether you’re a patient, provider, researcher or in the pharmaceutical industry, we’re here for you. More than 70,000 employees strong, we serve clients in more than 100 countries.

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

**What you can expect from us**:

- flexible working hours, capped overtime and compensatory time off in lieu
- travel time = work time
- highly competitive compensation packages
- subsidized meals and transportation allowances
- bonus schemes / profit sharing
- regular, merit-based salary adjustments
- significant employer contribution to an attractive pension scheme
- extensive insurance coverage, including medical, life, short as well as permanent disability and accidents
- excellent training and career development opportunities as well as support with furthering your education
- strong support from Line Management and more than 20'000 colleagues worldwide
- the world's most renowned pharmaceutical companies as our satisfied, repeat customers for many years

**Your responsibilities**:

- Own all aspects of site management as described in the project plans.
- Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study.
- Protect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by diligently reviewing source documents. Monitor data for missing or implausible entries.
- Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; submit accurate and timely trip reports.
- Review progress of projects and initiate appropriate actions to achieve target objectives.
- Act as a primary contact for clinical trial suppliers and other vendors.
- Own the entire process of Serious Adverse Event (SAE) reporting
- Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems

**Education**:

- Degree in a relevant field such as life sciences, biology, health care (management), nursing, pharmacology, (veterinarian) medicine, etc.
- In lieu of the above, a valid certification in health / life sciences by an accredited institute

**Experience**:

- Solid independent monitoring experience in France as CRA, with a focus on complex clinical trials (phases II and III)
- Proven experience in a variety of therapeutic areas, preferably including oncology
- Awareness of applicable clinical research regulatory requirements such as local regulations, GCP / ICH and the French regulatory authorities landscape
- IT-literate, including Microsoft Word, Excel, PowerPoint, and preferably eTMF solutions such as Veeva Vault
- Effective time management and organizational skills and a keen attention to detail
- Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders
- Excellent communication skills in both French and English - spoken and written - are a must

**Did you know?**

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in th

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