Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
CRA I (m/f)
Your tasks and responsibilities
- All aspects of site management and monitoring activities for assigned applicable Phase I and all Phase II-IV clinical Investigator sites within the approved Clinical Development Plan (CDP). These global, complex studies are conducted within the standards set by Bayer Global Development, according to Good Clinical Practices (ICH - GCP) and applicable regulatory and legal requirements.
- Managing Investigator site and site activities and monitoring site data, to ensure patient safety and ethical and regulatory compliance necessary to provide quality data required for global regulatory submissions for approval of drugs.
- Managing Investigator sites to ensure the Investigator and Site Staff meet all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out.
- Rigorous regulatory guidelines exist to ensure overall patient safety related to reporting of serious or unexpected adverse drug reactions. The CRA I is responsible for training the Investigator and site staff on these strict regulations and procedures for timely reporting and as well as ensuring ongoing compliance. Strict adherence is essential to remain complaint with on time reporting from Bayer to regulatory authorities and critical for thorough and timely evaluation of patient safety.
- Due to the highly regulated clinical trial environment, the CRA I proactively identifies potential issues and develops site Corrective Actions / Preventive Actions (CAPAs). The CRA I ensures timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data.
Who you are
- Master/Bachelor of Science degree
- At least 2 – 4 years of relevant healthcare experience in the pharmaceutical industry or clinical research.
- Knowledge of the drug development process including monitoring and site management, local and international regulations, ICH – GCP, drug safety requirements, data management
- Delivery focused with a strong ability to multitask, organize and priorities.
- Communication skills
- Effective written and verbal local language and English communication skills
Place of work: Milano, Viale Certosa 210
Contract: full time, fix term contract 12 months
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.