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.
Clinical Study Manager，Animal Health
Your tasks and responsibilities
- Ascertaining which studies need to be conducted with consideration to the regulatory requirements for each trial. Develop a clinical studies plan for each project, including a decision tree for different scenarios andoutcomes.
- Proposing investigators - appropriate investigators for the study are selected based on experience in the trial area and ability to perform the study to required standard.
- Compliance to Bayer international Standard Operating Procedures and GCP/GLP GL .
- Study Management - Schedule monitoring visits to ensure sites performing studies comply with predetermined standards. Maintain an internationally acceptable query rate in respect to trials.
- Relationship Management - building and maintaining positive relationships with appropriate study providers ensuring to be a strong advocate for Bayer's interests.
- Alignment with Head of Clinical Development RI for clinical development activities in China. Liaise and cooperate with functions directly or indirectly related to clinical study management, i.e. local regulatory affairs, QA management, project management, drug safety, clinical development etc in DRI and globally.
- Budget management -Forecasting budget for the studies, regular review of specific trial budget to ensure that the trial budget is not exceeded, with monthly reports submitted. All parties are paid on time as required.
- Close out of trial - to ensure that theDRI China obtains the final trial write up in an appropriate timeframe. To ensure that the study results and reports are provided in a format that is appropriate for the targeted Regulatory Authority.
Who you are
- Plans and Aligns
- Drives Results
- Manages Complexity
- Focus on Customer Needs
- Tertiary qualified in Animal Health field (preferably a Veterinarian)
- Broad experience in the design and conducting of animal studies
- Experience in Residue, Efficacy, Safety, Bioequivalence studies
- Excellent planning, organizational and administrative skills
- Strong analytical skills, good knowledge of Statistics
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.
Location: BeiJing, Shanghai, GuangZhou, ChengDu