Global Senior Clinical Trial Manager

Open for hire at one of the following locations –  Cambridge Erie Street, Mainz iNeST Facility. - Job ID: 7189 

 

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.

 

Global Senior Clinical Trial Manager 

 

The Senior Clinical Trial Manager (SCTM) is responsible for the execution of large-scale complex trials in early or late-stage development. They are also the Subject Matter Expert with regard to operational aspects. This implies preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP), and applicable SOPs. You will perform activities such as leading the cross-functional operational study team lead, independent oversight of third-party providers, and ensuring the study is on time with good quality. Escalating risks and issues. Timely problem and issue resolution across departments as necessary.

 

Responsibilities:

 

• Support the global clinical protocol development process in collaboration with Clinical Operations Management and Clinical Development (Medical Monitor): Contribute to the development of global clinical protocols, amendments, and related documents; drive and/or contribute to the development of trial-related documents and processes.
• Lead the global development of study tools, guidelines, and training materials to support effective and accurate execution of clinical trial activities.
• Develop relationships with global Investigators and Site Staff as primary contact for clinical conduct of the trial.
• Manage global study start-up activities, including regulatory documents, budgets, and clinical trial agreements, under the guidance of Clinical Operations Management.
• Participate in the ongoing review and cleaning of the clinical trial data.
• Chair study team meetings, collecting input from all functional lines.
• Participate in global site identification; attending PSVs and SIVs as necessary.
• Assist in the management of 3rd party vendors, including CRO, central lab, and imaging vendors.
• Manage global tracking, logistics and quality operations for biological samples supporting clinical trials from collection to analysis ensuring that sample inventories are accurate, complete, and up to date through effective interactions with global internal teams, sites, central reference labs, specialty lab partners, external collaborators (e.g. Academia) and third-party vendors.
• Ensure global GCP QA compliance for the lifecycle of your project.
• Communicate with management to ensure transparency throughout the course of the trial(s) regarding study metrics and overall status.
• Participate in global process improvement projects (as necessary).
• Ability to work independently as a senior associate.
• Ability to mentor junior staff in GCP/ICH guidelines as well as guide junior staff through the trial process.

 

Requirements:

 

• Bachelor’s degree in the life sciences or a university degree in a related field, with experience in a medical profession such as Nurse, Medical Technical Assistant, or Pharmaceutical Technical Assistant, with a minimum of 5 years experience in pharmaceutical/biotech or related industry.
• A minimum of 5 years of professional experience as a Clinical Study Manager, CRA/Clinical Monitor, or in a similar function, with at least 3 years managing a cross-functional team for study execution (Phas