Senior Manager, Clinical Research
Shanghai, China | full time | Job ID: 9278
Your main responsibilities are:
Team Leadership & Strategic Planning
- Lead and manage a national/regional CRA team and guide two individual teams leads (CRM) (Northern & Southern Region), for CRA group goal-setting, performance evaluation, and career development planning.
- Optimize clinical monitoring workflows, develop standardized SOPs, and ensure compliance with GCP, ICH guidelines, and local regulations.
- Collaborate cross-functionally (Clinical Dev, Data Management, Regulatory Affairs) to ensure trial milestones (enrollment, data quality, study closure) are achieved.
- Quality Assurance & Risk Management
- Oversee high-risk sites and complex projects (e.g., Phase I-III innovative drug trials, oncology/immunotherapy studies), resolving critical issues (SAE reporting, protocol deviations, data discrepancies).
- Conduct periodic reviews of monitoring reports and KPIs (e.g., SDV completion rate, query resolution time), and lead internal/external audits and regulatory inspections.
- Drive adoption of digital tools (eTMF, EDC systems) to enhance monitoring efficiency and data accuracy.
Resource Allocation & Productivity
- Manage clinical trial budgets (CRO outsourcing, travel expenses) and negotiate vendor contracts to reduce costs while maintaining quality.
- Evaluate and onboard high-performing CRO partners to ensure scalable and compliant trial execution.
- Regulatory Compliance & Industry Engagement
- Monitor updates to global clinical trial regulations (NMPA, FDA, EMA) and ensure team adherence.
What you have to offer:
- Master’s degree or higher in Clinical Medicine, Pharmacy, Life Sciences, or related fields. GCP certification is mandatory.
- Fluent in English
Your Benefits:
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.