Associate Director Clinical Data Management (Shanghai)
Open for hire at one of the following locations – Shanghai. - Job ID: 6303
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As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Associate Director Clinical Data Management (Shanghai)
As part of our global Clinical Data Management team, you'll contribute to our corporate success by supporting the roll out of the clinic programs in China. The Associate Director Clinical Data Management provides solid core and comprehensive data management expertise to provide high quality data management deliverables on clinical studies within his/her portfolio/platform program(s). He/She is overlooking the execution of clinical trials, with regard to operational and administrative aspects. This includes day-to-day project management, resource planning to the respective clinical portfolio/platform program(s). The ADCDM is working closely with the (Senior) Director Clinical Data Management to develop forward strategies and processes.
Your main responsibilities are:
• Organizes and conducts project team meetings.
• Provides guidance to project teams on the oversight and supervision of CRO/third party vendors and organizes trainings as needed. Acts as a mentor for new incomers or may delegate to appropriate team member this activity. Provides continuous feedback to develop team members.
• Contributes to the development and review of portfolio documents (includes contracts, guidelines, budgets, metrics, KPIs..)
• Complies with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
• Identifies the needs of new technology or tools for Data Management and takes active role during development and implementation.
• Supervises clinical data management activities within his/her portfolio/platform program and ensures it is per BioNTech standards and strategy.
• Escalates unresolved data or compliance issues to the functional manager(s).
• Provides guidance to Subject Matter Experts with regard to standard process developments.
• Ensures the trials processes are aligned within his/her portfolio/platform program(s) and escalates any deviations or foreseen non-compliance.
• Provides expert support to the Clinical Development Team, on study design issues for BioNTech development projects and portfolio/platform program(s).
• Represents his portfolio/platform program(s) team among other department leads and functions, and supports cross-functional interactions and problem solving.
• Participates in strategic vendor selection processes for Clinical Data Management, and actively participate in vendor relationship management, includes escalation.
• Provides input on developing, revising, and maintaining core operating procedures and templates.
• Provides support or assist Quality assurance department in conducting audits involving data management activities.
What you have to offer:
• Natural/ life sciences or scientific background (university degree) or former experience in a CRO/ biotechnology/ pharmaceutical company in a Clinical Data Management position
• Minimum 8-10 years of experience in Clinical Data Management with wide practice in oversight of DM activities as a Lead and DM project management
• Profound knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects and experience with Clinical Database Systems and processes
• Experience with Clinical Database Systems and processes
• Experience in leading project teams and resource planning
• Mandrin is must-have; Very good English (written and spoken)
• Effective communicative skills, active listener
• Excellent organizational skills
• Able to motivate and lead a team/ used to work in a team
• Able to work under stressful conditions
• Ready to take over responsibilities
• Able to recognize problems and provide solutions
• Detail oriented
• Experience in usual software (Word, Excel, Power Point)
• Experience with at least one Clinical Data Management System (Medidata, OCRDC, Inform, …)
• Independent and pro-active way of working
Benefits for you
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.
Click here to find out more about what we do, the careers we offer and also the benefits we provide.
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.
Have we kindled your pioneering spirit?
This vacancy is to be hired at one of the following locations – Shanghai. Apply now for your preferred job and location through our careers site.
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!