H-1B Visa Senior Clinical Project Manager Jobs
Senior Clinical Project Manager roles sit squarely within H-1B visa specialty occupation requirements, with employers routinely sponsoring petitions for candidates who hold a relevant bachelor's degree or higher. Pharma, biotech, and CRO sponsors file LCAs through DOL before submitting your I-129, so understanding that two-step process sharpens your search.
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INTRODUCTION
The Senior Clinical Project Manager is responsible for the management of all aspects of clinical trial conduct at the TRIAD Center including regulatory compliance, patient safety, data quality and personnel management. The ideal candidate will have proven senior management experience with excellent organizational, communication, and leadership skills. Under the direction of the Center Director and Associate Director, this person will independently manage, coordinate, and provide oversight of clinical research study conduct across multiple research studies and trials at multiple clinical sites. In addition, this person will serve in a key management and administrative role for all clinical research projects conducted at the TRIAD Center through the management of the clinical research team and ensuring compliance with established protocols, study timelines as well as institutional, local, and federal requirements.
The Clinical Research Project Manager is required to have an advanced knowledge of protocol requirements and good clinical practices as set forth by federal regulations. In addition, the Clinical Research Project Manager will support the development of research projects including proposal applications, scientific study design, IRB protocols, budgets, contracts, personnel recruitment, hiring, and training, as well as reports on expenses, progress, and effort in collaboration with the Associate Director. The Clinical Research Project Manager will work closely with superiors and executive-level management to define strategic goals for the Center as well as develop and implement operational plans in order to achieve said goals. Furthermore, the candidate will develop, oversee, and maintain relationships with Institutional Review Board, internal and external investigators, other personnel at external clinical sites, funding sponsors, vendors, and other key stakeholders.
BASIC QUALIFICATIONS
- Bachelor’s degree required
- At least three (3) years management experience
PREFERRED QUALIFICATIONS
- Preferred Master’s, Ph.D or M.D
- 5+ years of experience managing and training clinical research staff
- 5+ years of experience conducting cardiovascular research studies
- Certification as a Certified Clinical Research Coordinator (CCRC through the Association of Clinical Research Professionals or ACRP) OR Certified Clinical Research Professional (CCRP through the Society of Clinical Research Associates or SoCRA) is strongly desired.
- Regulatory Affairs Certification (RAC), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or Certified IRB Professional (CIP) preferred
- Proven ability to plan and manage operational processes for maximum efficiency and productivity
- Outstanding organizational, negotiation, communication, and leadership, and people skills demonstrated by previous professional success
- Proven ability to develop innovative solutions for increased productivity
- Working and in-depth knowledge of FDA, ICH GCP, and other regulatory compliance guidelines
- Working and in-depth knowledge of federal regulations and IRB procedures
- Working and in-depth knowledge of IRB submission process and requirements
- Excellent organizational, problem-solving, and leadership abilities
- Outstanding negotiation, communication and people skills
- In-depth knowledge of diverse operations functions and principles (e.g., resource management, finance)
- Ability to maintain confidentiality in all work performed
- Ability to acquire and maintain all required CITI training certificates
- Ability to acquire and maintain credentialing at all required institutions including Tulane Medical Center, University Medical Center, Touro Infirmary, East Jefferson Hospital
- Proven track record of successful clinical trial management including history of overseeing clinical research studies that are completed on time, within budget, and to the satisfaction of stakeholders
Tulane University is an equal opportunity educator and employer committed to providing an education and employment environment free of unlawful discrimination, harassment, and retaliation. Legally protected demographic classifications (such as a person’s race, color, religion, age, sex, national origin, shared ancestry, disability, genetics, veteran status, or any other characteristic protected by federal, state, or local laws) are not relied upon as an eligibility, selection or participation criteria for Tulane’s employment or educational programs or activities.
Tulane University is responsible for providing reasonable accommodations to individuals with disabilities throughout the applicant screening process. If you need assistance in completing an application or during any phase of the interview process, please contact the Office of Human Resources by phone at 504-865-4748 or by email at hr@tulane.edu.
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Senior Clinical Project Manager
Align your credentials to specialty occupation
USCIS requires your degree field to connect directly to clinical project management. A degree in life sciences, nursing, public health, or a related field strengthens your petition far more than a general management credential when responding to an RFE.
Search LCA filings by occupation code
Use the OFLC Wage Search to pull certified LCAs under SOC code 11-9111 for Medical and Health Services Managers. Employers with consistent LCA filings for that code have already demonstrated willingness to sponsor this specific role.
Target CROs and mid-size biotech sponsors
Contract research organizations and mid-size biotech companies carry high per-hire sponsorship rates for clinical roles because project headcount scales with trial volume, not company size. Filter your search on Migrate Mate to surface employers with active H-1B filing history in clinical operations.
Negotiate the timing of your I-129 filing
Cap-subject H-1B petitions must be filed for an October 1 start date. If you receive an offer outside that window, ask whether the employer will file in the next registration cycle and whether your current status allows a cap-gap extension to bridge the gap.
Document your GCP and regulatory experience precisely
USCIS adjudicators look for evidence that the role requires specialized knowledge. Your resume and support letter should specify ICH E6 Good Clinical Practice compliance, IND or NDA experience, and any Phase II or III trial oversight to establish specialty occupation clearly.
Verify the employer's prevailing wage tier
The DOL assigns your LCA wage to one of four prevailing wage levels. Cross-check your offered salary against the OFLC Wage Search for your work location before signing. A mismatch between your offer and the certified wage level can stall or invalidate your petition.
H-1B Visa Senior Clinical Project Manager: Frequently Asked Questions
Does a Senior Clinical Project Manager role qualify as a specialty occupation for H-1B purposes?
Yes. USCIS classifies Senior Clinical Project Manager positions as specialty occupations because the role normally requires at least a bachelor's degree in a directly related field such as life sciences, nursing, pharmacy, or public health. The O*NET profile for Medical and Health Services Managers supports this classification, and employers should document the degree requirement explicitly in the LCA and support letter.
Which employers sponsor H-1B visas for Senior Clinical Project Manager positions?
Pharma companies, contract research organizations, hospital systems with dedicated clinical research departments, and medical device manufacturers are the most consistent H-1B sponsors for this role. You can browse employers with verified H-1B filing history in clinical operations on Migrate Mate, which surfaces DOL Labor Condition Application data so you can see sponsorship patterns before applying.
How does the LCA process work for a Senior Clinical Project Manager H-1B?
Your employer files a Labor Condition Application with DOL before submitting your I-129 petition to USCIS. The LCA certifies that the offered wage meets the prevailing wage for your role and location, and that hiring you won't adversely affect similarly employed U.S. workers. DOL typically certifies LCAs within seven business days, but the employer must post the LCA notice at the worksite for ten days before filing.
Can I switch employers between H-1B approval and my start date?
If you're already in H-1B status, you can transfer to a new employer under H-1B portability once the new employer files an I-129 on your behalf, without waiting for approval. If you haven't started working under the approved petition yet, portability rules are more restrictive and you should confirm your specific situation with your prospective employer's immigration counsel before accepting a competing offer.
What documentation should I prepare before a sponsor files my H-1B petition?
Gather your academic transcripts and degree certificates, a credential evaluation if your degree is from outside the U.S., your current resume emphasizing clinical trial phases and regulatory frameworks you've managed, any professional certifications such as PMP or CCRP, and copies of previous visa approvals or I-94 records. Employers filing under a tight timeline appreciate having these documents ready before the petition preparation begins.