Senior Manager, Clinical Data Management Programming
Senior Manager, Clinical Data Management Programming
Shanghai, China | full time | Job ID: 9285
Your main responsibilities are:
- Provides Rave Application administration and technical support, including but not limited to iMedidata, Classic Rave, Rave EDC, Business Objects, and Coder.
- Provides technical support for core configuration, Medidata Rave user and site administration and overall URL ownership and maintenance including systems validation, periodic review.
- Performs programming of database screens and dynamics, as well as simple, complex, and custom function edit checks and study migrations.
- Works closely with Data Management group to create and understand EDC build specifications, develop, execute, and document test plans, provide support of application testing addressing system version upgrades, study build releases.
- Perform post-production change management.
- Serves as a member on the CDM initiatives. Participates in discussions between Clinical Data Management, IT, Clinical Operations, and Programming, to ensure proper methods are used for reporting (i.e., SAS, Business Objects, Data Visualization tools, etc.), metrics and analytics.
- Develops new reports, tools, and dashboards for EDC related metrics and data-driven insights.
- Participate in the evaluation and implementation of various CDM systems (e.g., Rave EDC, CTMS, Rave Safety Gateway) including 21 CFR Part 11 compliant systems requiring validated implementation to meet regulatory authority’s requirements, as necessary.
- Supports data standards development and implementation by ensuring system quality and compliance, and alignment to industry standards. Manages the BioNTech standard global library.
- Performs other duties as assigned.
What you have to offer:
- Bachelor's degree, preferably in computing, engineering, or scientific discipline or equivalent experience
- 8+ years of clinical data management experience in biotechnology, CRO, or pharmaceutical industry.
- 6+ years of Electronic Data Capture (EDC) study build and administration experience (EDC Study builder, Migration Programmer, CF Programmer, EDC Systems administrator) required.
- Medidata Rave EDC System administration experience required.
- Medidata applications experience required.
- Strong Programming experience in SAS and/or Business Objects preferred.
- Practical experience with programming using SAS, SQL, JREVIEW or Spotfire preferred.
- Must have strong knowledge of Data Management processes and systems.
Understanding of clinical drug development processes is required.
- Must have demonstrated problem-solving abilities in a team environment and strong organizational skills and the ability to work in a fast-paced environment.
- Excellent written and verbal communication skills are required.
- Experience and understanding of ICH and GCP are required.
- Refined colloquial and correspondence (written and spoken)
- Very good English (written and spoken)
- Able to rapidly enter in action and to work under stress conditions.
- Used to work, lead and coordinate external vendors and external teams.
- Able to recognize problems and provide solutions.
- Clinical Trial knowledge is required.
- Exceptional project management skills and high cross functional influence skills
- Excellent communication skills organized and ability to lead tasks from concept to delivery.
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.
Inspired? Become part of #TeamBioNTech.
BioNTech, the story
At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.
Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage?creativity, and develop business strategies driven by our shared passion for advancing medicine.
Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.
BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!?
