Washington, DC · On-site
$90K - $140K/yr
Master's or PhD in Data Science, Biostatistics, Health Economics, Epidemiology, Public Health ... Experience working with data in Medicare Standard Analytic Files (SAF), Research Identifiable Files ...
Quick apply
Washington, DC · On-site
$90K - $140K/yr
Master's or PhD in Data Science, Biostatistics, Health Economics, Epidemiology, Public Health ... Experience working with data in Medicare Standard Analytic Files (SAF), Research Identifiable Files ...
... e.g., clinical trial and marketing applications) in alignment with global filing plans and ... Doctorate degree and 2 years ofregulatory experience OR Master's degree and 4 years of regulatory ...
... e.g., clinical trial and marketing applications) in alignment with global filing plans and ... Doctorate degree and 2 years ofregulatory experience OR Master's degree and 4 years of regulatory ...
Manassas, VA · On-site
$170K - $205K/yr
... filed for FAA Part 23 type certification, and carries 2,000+ intent to purchase from operators ... Bonus Points * Master's Degree or MBA. * Experience participating in a full-cycle ERP ...
Manassas, VA · On-site
$170K - $205K/yr
... filed for FAA Part 23 type certification, and carries 2,000+ intent to purchase from operators ... Bonus Points * Master's Degree or MBA. * Experience participating in a full-cycle ERP ...
Manassas, VA · On-site
$170K - $205K/yr
... filed for FAA Part 23 type certification, and carries 2,000+ intent to purchase from operators ... Bonus Points * Master's Degree or MBA. * Experience participating in a full-cycle ERP ...
Manassas, VA · On-site
$170K - $205K/yr
... filed for FAA Part 23 type certification, and carries 2,000+ intent to purchase from operators ... Bonus Points * Master's Degree or MBA. * Experience participating in a full-cycle ERP ...
Manassas, VA · On-site
$170K - $205K/yr
... filed for FAA Part 23 type certification, and carries 2,000+ intent to purchase from operators ... Bonus Points * Master's Degree or MBA. * Experience participating in a full-cycle ERP ...
Quick apply
Manassas, VA · On-site
$170K - $205K/yr
... filed for FAA Part 23 type certification, and carries 2,000+ intent to purchase from operators ... Bonus Points * Master's Degree or MBA. * Experience participating in a full-cycle ERP ...
$12.39 - $18.84
4% of jobs
$18.84 - $25.29
9% of jobs
$28.59 is the 25th percentile. Wages below this are outliers.
$25.29 - $31.75
24% of jobs
The median wage is $37.51 / hr.
$31.75 - $38.20
15% of jobs
$38.20 - $44.65
16% of jobs
$49.01 is the 75th percentile. Wages above this are outliers.
$44.65 - $51.10
11% of jobs
$51.10 - $57.55
10% of jobs
$57.55 - $64.01
8% of jobs
$64.01 - $70.46
0% of jobs
$70.46 - $76.91
2% of jobs
$76.91 - $83.36
2% of jobs
$12
$42
$83
To thrive in a Trial Master File (TMF) Specialist role, you need meticulous organizational skills, comprehensive knowledge of regulatory requirements for clinical trials, and often a bachelor's degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, document management platforms, and relevant GCP (Good Clinical Practice) certifications is commonly required. Attention to detail, proactive communication, and the ability to collaborate effectively across clinical research teams are key soft skills. These competencies ensure regulatory compliance and seamless documentation, which are critical for the successful conduct and audit-readiness of clinical trials.
A Trial Master File (TMF) job involves managing and maintaining essential documents related to clinical trials to ensure compliance with regulatory requirements. Professionals in this role organize, track, and audit critical trial documentation to support inspections and submissions. They work closely with clinical teams, sponsors, and regulatory authorities to ensure proper documentation is accurate, complete, and audit-ready throughout the trial lifecycle.
As a TMF Specialist, your main responsibilities include managing, organizing, and maintaining all essential clinical trial documentation to ensure compliance with regulatory standards. On a daily basis, you will review and upload documents to eTMF systems, track document status, resolve discrepancies, and support study teams during audits or inspections. You'll collaborate closely with clinical research associates, project managers, and quality assurance teams to ensure the TMF is complete and inspection-ready at all times. The work is detail-oriented and deadline-driven, offering opportunities to develop expertise in regulatory standards and advance into roles such as TMF Manager or Clinical Trial Associate.
$90K - $140K/yr
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 16 days ago
About Us
ADVI Health: Expert Advice. Clear Vision.
Since 2013, clients have sought ADVI Health’s expert advice, informed by data and guided by a clear vision of the complex intersection of life sciences/healthcare innovation, economics, policy, and patient impact. Our aim is to be the leading and most knowledgeable go-to-market access and commercialization partner for life sciences and healthcare innovators, worldwide.
We are a collaborative team of consultants and advisors, all of whom are veterans of top healthcare and life sciences organizations, the federal government, state government, top consultants, nonprofits, commercial payers, or data and analytics companies. Our work cuts through complexity across asset, franchise, corporate, and executive level strategy, shapes markets, and enables therapies to launch faster, smarter, and at scale in multiple therapeutic areas, lifecycle stages, and areas of the world. Our global client roster includes biopharma manufacturers, MedTech, precision medicine diagnostics and tools companies, and cancer provider and patient organizations, from the C-suite down and across the product lifecycle. We solve complicated problems with data-informed commercialization, market access, and policy expertise. Based in Washington, DC and Austin, TX, the company delivers insight- and data-informed advice and vision for leaders in healthcare business and policy. ADVI offers a comprehensive perspective by integrating business, policy, and science to find creative solutions through data, learned insight, and compelling strategy to help clients make decisions across all healthcare segments.
ADVI is at the forefront of healthcare delivery transformation, payment reform, public and private payer coverage, and healthcare merger and acquisition deal flow within the US and abroad. Learn more... visit us at www.advi.com
Position Overview:
We are seeking a Data Scientist to join our growing Strategic Analytics, Value, and Economics team. In this role, you’ll leverage advanced data science and health economics methods to help shape access to life-saving therapies and innovations. You’ll work with rich, real-world healthcare data including Medicare and Medicaid claims to uncover insights that directly inform policy, pricing, and patient access decisions across the life sciences sector. This position offers the opportunity to apply your analytical expertise to real-world evidence (RWE), health outcomes, and market access challenges while making a measurable impact on how treatments reach the patients who need them most.
The person in this role will perform healthcare claims-based analytics for a variety of internal and client-facing teams. Analytics work will include health economics and outcomes research (HEOR), market basket assessment of diseases or treatment usage, and related evidence-generation studies.
Job Duties
• Designing and executing analyses in Medicare and Medicaid healthcare claims
• Lead in the development and production of deliverables (Excel workbooks and power point decks) as well as communicating results to shareholders
• Manage data analysts and assist in the QA of programs and analyses
Location
Candidates can be based anywhere in the U.S., with a preference for those operating in the Eastern or Central Standard Time Zone. Candidates based in Washington, DC or Austin, TX, will have the option of hybrid work arrangements.
Compensation and Benefits
The salary range is $90,000-$140,000 annual base salary plus bonus plan. Exceptionally qualified candidates will be evaluated according to experience levels. Please include your salary requirements with your application if they exceed the posted range. ADVI offers an outstanding benefits package, including the following:
· Medical, dental, and vision
· 8 paid holidays, including one ADVI Anniversary Day per calendar year
· 401(k) retirement contribution match, up to 3 percent of salary, with immediate vesting
· Health Reimbursement Account
· Life and short-term and long-term disability insurance
· Paid vacation and sick leave
Diversity Statement
ADVI’s commitment to diversity, equity, inclusion, and collaboration is key to building extraordinary teams. We hire people with exceptional talents, abilities, and potential, then build an environment where you can become the best version of yourself.
Our Vision
To be the leading and most knowledgeable go-to-market access and commercialization partner for life sciences and healthcare innovators worldwide.
Our Mission
To provide life science and healthcare innovators the benefit of our team’s wisdom, empathy, and creativity that, through data-informed strategy, generates evidence to optimize outcomes and, through tech-enabled access solutions, creates opportunities and expands care.
Our Values
Act with Integrity
Strive for Excellence
Make an Impact
Think smart, Stay curious
Celebrate the Journey, not just the results
We look forward to hearing from you!
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