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Pharma Clinical Manager ID172790
30-40万/年
人 · 硕士 · 3年及以上工作经验 · 性别不限2024/09/27发布
五险一金专业培训年终奖金补充医疗保险免费班车定期体检补充公积金带薪年假人才保留奖金

中关村生命科学园区生命园路8号14号楼4层

公司信息
硕腾生物制药有限公司

外资(欧美)/50-150人

该公司所有职位
职位描述
Position Summary:
This role will be responsible for leading, coordinating and supporting GCP clinical study activities of Zoetis' pharmaceutical products to assure the study planning, execution, and monitoring are conducted in compliance with Zoetis' policies and appropriate regulatory requirements.
Essential Duties and Responsibilities:
To lead the clinical studies for Zoetis' pharmaceutical products with all study stakeholders, including study timeline planning, budgeting, study protocol preparation, risk assessment, study execution, monitoring, data records check, data auditing, data management and study reporting.
To support on clinical developing strategies, processes and activities to ensure compliance with Zoetis' requirements and study guidelines, and China GCP requirements.
Be responsible for the coordination and management of study preparation to ensure study materials and documentation are in place for study start (e.g. site filing, contract signing, ethical approval, sample supplies, DCFs etc.)
To be a study monitor, develop the monitoring plan, visit sites regularly, check the study records to ensure the protocol and monitoring plan are consistently and appropriately implemented. Track the study progress to deliver milestones and ensure the high quality of study data.
To provide study related trainings, organize discussion meetings, proactively identify and resolve study-related issues and seek opportunities to accelerate the study enrollment and study reporting.
As appropriate, to support the planning, execution, or monitoring of animal studies of Zoetis' biological products under the lab or field condition.
Requirements:
1. At least Master's degree from veterinary or relevant field in pharmaceuticals, clinical development, veterinary drugs is preferred. Knowledge on drug development process and clinical research methodology (e.g. study design, monitoring).
2. At least 3 years of experience in clinical practice and management. Be familiar with GCP and related study guidelines.
3. Self-motivated and strong team player. Excellent organizing skills and communication skills with both internal and external partners, as well as fluent in English (verbal and written).
4. Proactive in problem solving, strong sense of responsibility and has influence in interactions with regulatory authorities.
5. Willingness to work flexible hours and travel as required.

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