Associate Director, Country Clinical Trial Management​ (Shanghai, SH, CN, 200050)

Shanghai, China   |   full time   |   Job ID: 11391

Your main responsibilities are:

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

What you have to offer:

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)

Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects

Minimum 8 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

First functional and/or disciplinary leadership experience

Very good English and Mandarin (written and spoken), refined colloquial and correspondence skills

Experience in usual software (Word, Excel, Power Point, MS Project)

Ready to take over responsibility

Able to rapidly enter in action and to work under stress conditions

Used to work in a team, experience in leading a team

Able to recognize problems and provide solutions

Good organizational skill

Good communicative skills

Pro-active way of working, used to work independent

Should have the good country level experience of global study delivering with outsourcing model

Your benefits and remuneration:

If the position is filled in the US, the Expected Pay Range is XXX,XXX/year to XXX,XXX/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

Compensation at other locations may vary significantly.

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.

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