Sr. Manager, Clinical Trial Management

at  BioNTech AG

Schleswig-Holstein, Schleswig-Holstein, Germany -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate15 Feb, 2025Not Specified16 Nov, 2024N/AGood communication skillsNoNo
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Description:

JOIN OUR TEAM OF PIONEERS!

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.

HOW TO APPLY:

Apply now and simply send 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 by using our online form.

Please note:

  • Only applications sent via our online form shall be considered.
  • Only Candidates with the right qualifications and relevant experience shall be shortlisted and
  • Incomplete applications shall be rejected.
  • Please note that BioNTech will run a background check during the hiring process

We are looking forward receiving your application.
*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!
BioNTech - As unique as you
www.biontech.co

Responsibilities:

  • Lead and Drive study delivery in China
  • Support in preparation of regular status reports to local DCO and global CTM/Platform Lead, including presentation of project status in meetings
  • Overlooking the clinical operation trial budget in country level
  • Opportune contact with PM and ADCO in case of divergences from the project plan
  • Oversight on project timelines and deliverables in country level
  • Set-up or oversight of study related documents such as Trial Management Plan, Monitor Manual, etc.
  • Contribution to and review of study core documents and contribute to local customization, e.g. synopsis, investigator’s brochure, patient informed consent documents etc.
  • Coordination of project activities with other internal departments or external vendors from start-up to close out of a clinical trial
  • Support in planning and conduct of project training prior to starting project activities, oversight
  • 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
  • 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
  • China KOL engagement ability with the support from clinical dev and GMA
  • Engage with and provide oversight to our CRO partners in China
  • 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
  • Ensure the quality and integrity of outsourced clinical trials
  • Actively identify and manage any internal and external risks to the business
  • Build and maintain strong relationships with local vendors including but not limited to CROs, patient advocacy groups and SMOs at strategic and operational levels
  • Build processes and actively support CROs to achieve best in class site activation timelines for outsourced trials in China
  • Work on the efficient collaborations with our strategic development partners in China
  • Provide operational oversight of joint clinical trial programs including verifying partner company SOP, system, staff qualification, etc.
  • Serve as a point of escalation in case of challenges in project activities
  • Play an active role in helping to bridge cultural gaps and language barriers


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

A medical profession such as nurse or medical technical assistant or pharmaceutical technical assistant

Proficient

1

Schleswig-Holstein, Germany