Associate Director, Clinical Data Management Programming

New Jersey, US; Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany | full time | Job ID: 9750

Job Summary:

We are seeking a strategic and experienced Associate Director of Clinical Data Management Programming to support and enhance our clinical programming and database setup capabilities. This role plays a key part in ensuring regulatory compliance, operational efficiency, and data integrity across global clinical trials and submissions. The Associate Director will lead technical initiatives, contribute to process optimization, and collaborate closely with cross-functional teams to deliver high-quality data solutions in a fast-paced, innovative environment

Responsibilities:

• 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.
  
  

Qualifications:

Education

• Bachelor's degree, preferably in computing, engineering, or scientific discipline or equivalent experience
  
  

Experience

• 10 years of clinical data management experience in biotechnology, CRO, or pharmaceutical industry.
• 8 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.
  
  

Expected Pay Range (US): $176000/year to $215000/year benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

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.