H-1B Visa Associate Director Clinical Data Management Jobs
Associate Director Clinical Data Management roles qualify as H-1B visa specialty occupations under USCIS guidelines, requiring at least a bachelor's degree in a directly related field. Sponsors file the LCA with DOL before petitioning, and most large CROs and pharma companies have established H-1B visa filing programs for this level.
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Get Access To All JobsLocation: Cambridge, US; Gaithersburg, US; New Jersey, US
Job Type: full time
Job ID: 11678
About the Role:
As Associate Director Clinical Data Management, you will take a leading role in ensuring high-quality data management deliverables across clinical studies within your portfolio. You will lead talented teams, oversee clinical trial execution, and contribute to shaping forward-thinking strategies and processes alongside the (Senior) Director of Clinical Data Management. Your work will directly support BioNTech’s mission to develop pioneering therapies that improve health outcomes worldwide.
This role offers a collaborative and dynamic environment where your leadership and expertise will drive innovation and operational excellence. You’ll be at the heart of our clinical programs, helping to transform groundbreaking science into impactful treatments.
Your Contribution:
- Lead Clinical Data Management Teams, driving operational excellence in clinical trials
- Manage team development, resource planning, hiring, and allocation for portfolio programs
- Provide guidance on oversight and supervision of CROs/third-party vendors, including organizing training sessions
- Develop and review portfolio documents such as contracts, budgets, metrics, KPIs, and guidelines
- Identify opportunities for new technologies or tools in data management and lead their implementation
- Ensure compliance with Good Clinical Practices (GCPs), regulatory guidelines, SOPs, policies, and CDM standards
A Good Match:
- University degree in natural/life sciences or equivalent experience in Clinical Data Management within a CRO/biotechnology/pharmaceutical company
- Proven track record with at least 12 years of experience in Clinical Data Management, including team leadership and project management
- In-depth knowledge of international guidelines (ICH-GCP) for clinical research projects
- Hands-on experience with Clinical Database Systems (e.g., Medidata Rave, OCRDC, Inform)
- Strong communication skills with fluency in English (written and spoken)
- Excellent organizational skills; ability to lead teams effectively while working under pressure
- Proactive mindset with problem-solving abilities; detail-oriented approach to work
Your benefits and remuneration:
If the position is filled in the US, the Expected Pay Range is $146,300/year to $209,400/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.
Compensation at other locations may vary significantly.
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!
BioNTech - As unique as you
Location: Cambridge, US; Gaithersburg, US; New Jersey, US
Job Type: full time
Job ID: 11678
About the Role:
As Associate Director Clinical Data Management, you will take a leading role in ensuring high-quality data management deliverables across clinical studies within your portfolio. You will lead talented teams, oversee clinical trial execution, and contribute to shaping forward-thinking strategies and processes alongside the (Senior) Director of Clinical Data Management. Your work will directly support BioNTech’s mission to develop pioneering therapies that improve health outcomes worldwide.
This role offers a collaborative and dynamic environment where your leadership and expertise will drive innovation and operational excellence. You’ll be at the heart of our clinical programs, helping to transform groundbreaking science into impactful treatments.
Your Contribution:
- Lead Clinical Data Management Teams, driving operational excellence in clinical trials
- Manage team development, resource planning, hiring, and allocation for portfolio programs
- Provide guidance on oversight and supervision of CROs/third-party vendors, including organizing training sessions
- Develop and review portfolio documents such as contracts, budgets, metrics, KPIs, and guidelines
- Identify opportunities for new technologies or tools in data management and lead their implementation
- Ensure compliance with Good Clinical Practices (GCPs), regulatory guidelines, SOPs, policies, and CDM standards
A Good Match:
- University degree in natural/life sciences or equivalent experience in Clinical Data Management within a CRO/biotechnology/pharmaceutical company
- Proven track record with at least 12 years of experience in Clinical Data Management, including team leadership and project management
- In-depth knowledge of international guidelines (ICH-GCP) for clinical research projects
- Hands-on experience with Clinical Database Systems (e.g., Medidata Rave, OCRDC, Inform)
- Strong communication skills with fluency in English (written and spoken)
- Excellent organizational skills; ability to lead teams effectively while working under pressure
- Proactive mindset with problem-solving abilities; detail-oriented approach to work
Your benefits and remuneration:
If the position is filled in the US, the Expected Pay Range is $146,300/year to $209,400/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.
Compensation at other locations may vary significantly.
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!
BioNTech - As unique as you
See all H-1B Visa Associate Director Clinical Data Management Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Associate Director Clinical Data Management
Verify your degree aligns with the role
USCIS scrutinizes degree-to-job fit for CDM director-level roles. A degree in biostatistics, health informatics, or life sciences maps cleanly. A general business degree may trigger an RFE, so gather transcripts and a credential evaluation before applying.
Target CROs and mid-size pharma sponsors
Contract research organizations and mid-size pharmaceutical companies file H-1B petitions for CDM leadership positions more consistently than small biotech startups. Search Migrate Mate to filter employers by verified LCA filing history for this specific role.
Check prevailing wage before negotiating offers
Your employer must certify your salary meets the DOL prevailing wage for your location and job level. Run your title and metropolitan area through the OFLC Wage Search before salary discussions to avoid offers that can't clear LCA certification.
Document CDISC and regulatory experience explicitly
H-1B petitions for CDM roles benefit from evidence tying your credentials to specialty occupation standards. Highlight CDISC CDASH and SDTM expertise, FDA submission experience, and any 21 CFR Part 11 compliance work in your resume and support letters.
Time your petition to avoid cap-gap gaps
If you're on OPT, your employer must file by April 1 for an October 1 start. A gap between OPT expiration and H-1B activation can disqualify you from continuing work. Confirm your employer's internal filing deadlines at least 90 days before your EAD expires.
Request premium processing for director-level offers
USCIS premium processing adjudicates the I-129 petition within 15 business days. At the Associate Director level, employers are often willing to pay for this, and it removes uncertainty during onboarding timelines for projects with fixed study startup dates.
H-1B Visa Associate Director Clinical Data Management: Frequently Asked Questions
Does an Associate Director Clinical Data Management role qualify as an H-1B specialty occupation?
Yes. Associate Director CDM roles require at least a bachelor's degree in a directly related field such as biostatistics, health informatics, computer science, or a life science. USCIS defines specialty occupation as a role where that specific degree is a minimum requirement, not merely preferred, and CDM director-level positions consistently meet that standard based on the technical and regulatory expertise required.
Which employers regularly sponsor H-1B visas for CDM director roles?
Large contract research organizations, top-50 pharmaceutical companies, and mid-size biotech firms with active clinical pipelines are the most consistent H-1B sponsors for CDM leadership positions. You can browse employers with verified LCA filing history for this role on Migrate Mate, which filters listings by actual DOL Labor Condition Application data rather than self-reported sponsorship policies.
What documents should I prepare before applying for CDM director roles as an H-1B candidate?
Prepare a credential evaluation if your degree is from outside the U.S., official transcripts, and a detailed resume that maps your experience to CDISC standards, FDA regulatory submissions, and any therapeutic area specializations. For the H-1B petition itself, your employer will also need a specialty occupation support letter and evidence that your role requires the specific degree USCIS scrutinizes at this seniority level.
How does the DOL prevailing wage requirement affect CDM director H-1B offers?
Your employer must file an LCA certifying that your offered salary meets or exceeds the DOL prevailing wage for your job title and work location before submitting the H-1B petition to USCIS. Offers below the prevailing wage cannot be certified, and the wage level assigned reflects your supervisory scope and years of experience. Use the OFLC Wage Search to look up the applicable wage before entering salary negotiations.
Can I switch employers as an H-1B holder in a CDM director role?
Yes, under H-1B portability rules established by AC21, you can start working for a new employer as soon as they file an H-1B transfer petition with USCIS, as long as your current H-1B status is valid and the new role is in the same or a similar occupational classification. You don't need to wait for USCIS to approve the transfer before starting, but your new employer must file promptly and the role must remain a specialty occupation.