Biologist as Manager Clinical Trials (m / f / d)

BioNTech SE; Mainz; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

A leading company in immunotherapy is seeking a Clinical Study Manager to supervise clinical studies and ensure quality standards. The role involves leading teams, preparing study documents, and ensuring compliance with regulations. Ideal candidates will have a background in life sciences and experience in clinical trials.

Leistungen

Competitive remuneration packages

Qualifikationen

• Minimum of 3 years of experience in project management or clinical trial coordination.
• Profound knowledge of ICH-GCP for clinical research projects.

Aufgaben

• Lead cross functional team for study execution.
• Responsible for defining and implementing study quality standards.
• Vendor oversight and issue resolution for studies.

Kenntnisse

Project Management

Problem Solving

Organizational Skills

Communication Skills

Ausbildung

University degree in natural/life sciences or medicine

Tools

MS Projects

Word

Excel

Power Point

Jobbeschreibung

London, United Kingdom; Cambridge, US; Mainz, Germany | full time | Job ID : 9115

As a part of our Global Clinical Operations Team, you will soon take the next step with us. Together with your colleagues, you will supervise clinical studies and support BioNTech become a worldwide forerunner for modern immunotherapies against cancer.

Your Main Responsibilities Are

• Lead a cross functional team for study execution for one or several studies
• Responsible for defining and implementing the study quality standards and study objectives as agreed with the program team
• Preparation and review of study documents with CROs as well as the selection of vendors for the study
• 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
• Plan, review, and conduct of training sessions relevant to the studies as well as team and investigator meetings / PSVs / SIVs

What You Have To Offer

• Background in natural / life sciences or medicine (University degree or experience in a medical profession such as Nurse, Medical Technical Assistant, or Pharmaceutical Technical Assistant)
• Minimum of 3 years of experience in project management, regulatory submissions, monitoring of clinical trials, or clinical trial coordination
• Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
• Very good English (written and spoken)
• Experience in usual software (Word, Excel, Power Point, MS Projects)
• Able to recognize problems and provide solutions
• Good organizational and communicative skills
• Pro-active way of working & ready to take over responsibility

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.