Manager, Clinical Trials

Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; New Jersey, US   |   full time   |   Job ID: 9745 

Your main responsibilities are:

• Supporting and eventually leading a cross functional team for study execution for one or several studies. May also support a Assoc. Director on this activity or may be responsible for a smaller program
• Responsible for defining and implementing the study quality standards and study objectives as agreed with the team for areas of responsibility.
• Responsible for Vendor oversight and issue resolution/escalation for the responsible studies
• Responsible for ensuring study timelines are per plan or mitigations are introduced to limit timeline shifts
• Work with cross functional team and the CRO to prepare and compile documents for ethics committee and health authority submission and study plans
• Review training materials relevant to the studies to ensure relevant and accurate information for areas of responsibility for team and site training.
• Delegation and supervision of one or more clinical trial specialists assigned to the studies
• Preparation and presentation of Study status, risks, and mitigations to management and the cross functional teams
• Support the above activities as an unblinded role for one or more trials, working with the unblinded CRO and Sponsor team members to address Quality Incidents and CAPAs.

Qualifications

• A bachelor’s degree in the life sciences or a university degree with experience in a health profession
• Minimum 4 years of professional experience in pharma/biotech as a Clinical Study Manager, Project Manager, CRA/Clinical Monitor or in a similar function, with experience coordinating a cross functional team for study execution (Phase 1-3)
• Experience working in Oncology or infectious diseases a plus
• Experienced working globally a plus
• Knowledge of relevant laws and regulations (e.g. ICH GCP guideline)
• Proactive, independent way of working as well as excellent communication and organizational skills

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.