Shanghai, China | full time | Job ID: 9276 Your main responsibilities are: <ul> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Lead and Drive study delivery in China <ul> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Support in preparation of regular status reports to local DCO and global CTM/Platform Lead, including presentation of project status in meetings</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Overlooking the clinical operation trial budget in country level</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Opportune contact with PM and ADCO in case of divergences from the project plan</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Oversight on project timelines and deliverables in country level</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Set-up or oversight of study related documents such as Trial Management Plan, Monitor Manual, etc.</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Contribution to and review of study core documents and contribute to local customization, e.g. synopsis, investigator’s brochure, patient informed consent documents etc.</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Coordination of project activities with other internal departments or external vendors from start-up to close out of a clinical trial</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Support in planning and conduct of project training prior to starting project activities, oversight</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Responsible for the execution of clinical trials, mainly with regard to operational and administrative aspects. This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. S/he performs activities related with leading the operational project team, the supervision/ control of third party providers, the timely performance of all services, as well as the problem management by interacting with all departments involved</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Support on clinical operational function development in China with the guidance of DCO, including but not limited to support on GCO initiative delivery in China</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">China KOL engagement ability with the support from clinical dev and GMA</li> </ul> </li> </ul> <ul> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Engage with and provide oversight to our CRO partners in China</li> <li style="list-style-type:none"> <ul> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">CRO and other vendor (including but not limited to SMO, referral company, QC/QA vendor, etc.) collaboration and oversight to ensure the high quality and full compliance</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Ensure the quality and integrity of outsourced clinical trials</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Actively identify and manage any internal and external risks to the business</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Build and maintain strong relationships with local vendors including but not limited to CROs, patient advocacy groups and SMOs at strategic and operational levels</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Build processes and actively support CROs to achieve best in class site activation timelines for outsourced trials in China</li> </ul> </li> </ul> <ul> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Work on the efficient collaborations with our strategic development partners in China</li> <li style="list-style-type:none"> <ul> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Provide operational oversight of joint clinical trial programs including verifying partner company SOP, system, staff qualification, etc.</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Serve as a point of escalation in case of challenges in project activities</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Play an active role in helping to bridge cultural gaps and language barriers</li> </ul> </li> </ul> What you have to offer: <ul> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Natural/ life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant)</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Minimum 5 years of experience in project management, regulatory submissions, monitoring of clinical trials or clinical trial coordination with practice in project planning and structuring within the biotechnology/pharmaceutical industry</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">First functional and/or disciplinary leadership experience</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Very good English and Mandarin (written and spoken), refined colloquial and correspondence skills</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Experience in usual software (Word, Excel, Power Point, MS Project)</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Ready to take over responsibility</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Able to rapidly enter in action and to work under stress conditions</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Used to work in a team, experience in leading a team</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Able to recognize problems and provide solutions</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Good organizational skill</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Good communicative skills</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Pro-active way of working, used to work independent</li> <li style="font-size:11.0pt;font-family:'Henderson BCG Serif', serif">Should have the good country level experience of global study delivering with outsourcing model</li> </ul> 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.

Senior Manager, Clinical Trial Management (Shanghai, SH, CN, 200050) @ BioNTech SE

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