Clinical Operations Training Lead*
Become a member of the BioNTech Family!
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.
Clinical Operations Training Lead*
Your main responsibilities are:
- Support VP, CDO and Sr. Director, Process Excellence in cross-functional efforts to build out infrastructure necessary to identify, evaluate and execute on functional growth opportunities
- Develop compliant, comprehensive, and effective training processes and sessions
- Continuously monitor training efficiency and effectiveness, proactively identify training gaps, and partner with key stakeholders to scope and ensure alignment with strategic priorities
- Identify required resources needed to support training efforts including personnel, tools, and facilities
- Develop GCP-compliant training processes and documentation
- Develop and execute training strategies for new, improved processes that support an agile working model
- Drive development and maintenance of CDO training curriculum, including Onboarding, Role-specific Process Training and Professional Development Programs ensuring all training reflects current industry best practices and regulatory standards in line with associated internal processes and systems
What you have to offer.
- Bachelor’s degree in a business, science or healthcare related field or equivalent. Master’s degree preferred.
- Many years of experience within Clinical Operations , Clinical Trial Management, Clinical Trial Monitoring or related function within pharmaceutical/ biotech/ CRO or related field is required. (i.e. CRA, Quality, Audit, Regulatory Compliance or similar)
- Significant experience in curriculum design in a pharmaceutical environment
- Ability to deliver training on critical aspects of Clinical Trial Management such as ICH/GCP Guidelines, Monitoring Oversight, Site Interactions, non-compliance, Risk management, Inspection readiness etc.
- Broad experience in the pharmaceutical industry with a strong clinical development understanding. Expert knowledge of ICH Guidelines, FDA/ MHRA/EMA regulations, EU Clinical Trial Directive and other applicable industry regulations, processes and practices is required.
- Proven ability to transfer knowledge to others and deliver training sessions that ensure maximum impact and retention.
- Successful and demonstrable track record building and executing new training initiatives
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 6480 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you