CPT Senior Clinical Trial Manager Jobs
Senior Clinical Trial Manager roles in pharma, biotech, and CROs sit squarely within clinical research, public health, and life sciences degree programs that authorize CPT. Your DSO must confirm the role is an integral curriculum requirement before you begin. Protocol management, site oversight, and regulatory compliance work all qualify.
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Get Access To All JobsAbout BOSTONGENE: BostonGene is redefining cancer patient care and drug development through the integration of omnimodal data and artificial intelligence. Built and validated through an extensive real-world clinical testing network, BostonGene’s Foundation Model of cancer and the immune system integrates genomic, transcriptomic, and immune data with clinical outcomes to generate biologically grounded, actionable insights. These insights enable biopharma partners to design and de-risk trials, identify novel targets, and optimize therapeutic response prediction across all stages of development while simultaneously improving patient care through clinically integrated innovation.
Position Overview
BostonGene is seeking a bench Scientist to join our R&D next-generation sequencing (NGS) team in our laboratory located in Waltham, MA. This candidate will support assay development and technical transfer in collaboration with immunology, production, and bioinformatics teams. The candidate will be expected to support NGS protocols, such as RNA and DNA isolation from tissue, cell-free DNA isolation from plasma, library preparation, QC, and other lab processes. The role will primarily require laboratory bench work (70-80%) in a BSL-2 laboratory.
Key Responsibilities:
- Perform assay and product development experiments of NGS workflows, including WGS, WES, and liquid biopsy assays for internal and external collaborators
- Troubleshoot and support the technical transfer of workflows to the production lab
- Maintain detailed and accurate records in LIMS, ELN, and in compliance with laboratory protocols and regulatory requirements
- Assist in the development of laboratory SOPs and batch records
- Execute and assist with validation studies, bridging studies, and technical reports
- Stay informed on emerging technologies and trends in NGS to support innovation in assay development
Qualifications
- Ph.D. in life sciences or related discipline with 0–3 years of relevant experience, OR M.S. with 3–6 years, OR B.S. with 6–10 years of hands-on experience. (The job title will be commensurate with experience.)
- Strong experience in nucleic acid extraction (DNA/RNA) from FFPE, blood, or other clinical samples
- Proficiency in NGS library prep (short-read and/or long-read), including WGS and WES
- Excellent problem-solving and troubleshooting skills
- Strong organizational skills with the ability to manage sample tracking, documentation, and inventory
Preferred Skills & Experience:
- Experience working with liquid biopsy samples (cfDNA/ctDNA, cfRNA, or exosomes)
- Familiarity with NGS QC metrics and analysis tools
- Understanding of assay validation in regulated environments (GCLP, ISO)
- Demonstrated experience in SOP development and process documentation
- Strong verbal and written communication skills, with the ability to work effectively in cross-functional teams
- Proven ability to work in a dynamic, fast-paced environment with shifting priorities
- Self-motivated and accountable, with a collaborative mindset
Additional Information
- Ability to stand for prolonged periods and perform repetitive tasks inherent to laboratory work.
About BOSTONGENE: BostonGene is redefining cancer patient care and drug development through the integration of omnimodal data and artificial intelligence. Built and validated through an extensive real-world clinical testing network, BostonGene’s Foundation Model of cancer and the immune system integrates genomic, transcriptomic, and immune data with clinical outcomes to generate biologically grounded, actionable insights. These insights enable biopharma partners to design and de-risk trials, identify novel targets, and optimize therapeutic response prediction across all stages of development while simultaneously improving patient care through clinically integrated innovation.
Position Overview
BostonGene is seeking a bench Scientist to join our R&D next-generation sequencing (NGS) team in our laboratory located in Waltham, MA. This candidate will support assay development and technical transfer in collaboration with immunology, production, and bioinformatics teams. The candidate will be expected to support NGS protocols, such as RNA and DNA isolation from tissue, cell-free DNA isolation from plasma, library preparation, QC, and other lab processes. The role will primarily require laboratory bench work (70-80%) in a BSL-2 laboratory.
Key Responsibilities:
- Perform assay and product development experiments of NGS workflows, including WGS, WES, and liquid biopsy assays for internal and external collaborators
- Troubleshoot and support the technical transfer of workflows to the production lab
- Maintain detailed and accurate records in LIMS, ELN, and in compliance with laboratory protocols and regulatory requirements
- Assist in the development of laboratory SOPs and batch records
- Execute and assist with validation studies, bridging studies, and technical reports
- Stay informed on emerging technologies and trends in NGS to support innovation in assay development
Qualifications
- Ph.D. in life sciences or related discipline with 0–3 years of relevant experience, OR M.S. with 3–6 years, OR B.S. with 6–10 years of hands-on experience. (The job title will be commensurate with experience.)
- Strong experience in nucleic acid extraction (DNA/RNA) from FFPE, blood, or other clinical samples
- Proficiency in NGS library prep (short-read and/or long-read), including WGS and WES
- Excellent problem-solving and troubleshooting skills
- Strong organizational skills with the ability to manage sample tracking, documentation, and inventory
Preferred Skills & Experience:
- Experience working with liquid biopsy samples (cfDNA/ctDNA, cfRNA, or exosomes)
- Familiarity with NGS QC metrics and analysis tools
- Understanding of assay validation in regulated environments (GCLP, ISO)
- Demonstrated experience in SOP development and process documentation
- Strong verbal and written communication skills, with the ability to work effectively in cross-functional teams
- Proven ability to work in a dynamic, fast-paced environment with shifting priorities
- Self-motivated and accountable, with a collaborative mindset
Additional Information
- Ability to stand for prolonged periods and perform repetitive tasks inherent to laboratory work.
Senior Clinical Trial Manager CPT: Frequently Asked Questions
Does Senior Clinical Trial Manager work qualify as an integral part of a clinical research curriculum for CPT?
It qualifies when your degree program in clinical research, public health, pharmaceutical sciences, or a related field explicitly includes industry practicum requirements. Your DSO evaluates whether the specific duties in the job description, such as protocol management, site monitoring, and regulatory submissions, map to your coursework. Generic program requirements aren't enough; the offer letter's scope of work needs to match your academic objectives.
Can I work full-time as a Senior Clinical Trial Manager on CPT while still enrolled?
Full-time CPT, defined as 20 or more hours per week, is allowed but affects your OPT eligibility. Twelve months or more of full-time CPT eliminates your standard OPT, including the STEM extension. Part-time CPT, under 20 hours weekly, doesn't carry that consequence. Most Senior CTM roles are structured as full-time, so discuss the OPT trade-off with your DSO before accepting.
How do I find Senior Clinical Trial Manager employers who are comfortable with CPT students?
Search Migrate Mate for Senior Clinical Trial Manager listings filtered by employers with Labor Condition Application history. LCA filings indicate the employer has sponsored or is actively sponsoring work visas, which correlates strongly with familiarity managing F-1 employment documentation. CROs and mid-size biotech firms tend to have more structured onboarding for students than large pharmaceutical companies.
What documents does the employer need from me before my CPT start date?
You'll need to provide your updated I-20 showing the CPT authorization with the correct employer name, start date, and end date, plus your F-1 visa stamp and passport. For Form I-9, your I-20 combined with your F-1 visa or I-94 establishes employment eligibility. Some employers also request your DSO's contact information to verify authorization directly, which is standard for clinical research roles handling GCP-regulated data.
Does CPT experience as a Senior Clinical Trial Manager strengthen a future H-1B petition?
U.S.-based clinical trial management experience directly supports the specialty occupation argument in an H-1B petition because it demonstrates that the role requires a degree-level background. ICH-GCP compliance work, protocol deviation adjudication, and IND or NDA submission experience are all documented activities that an employer's immigration counsel can reference when drafting the H-1B support letter.
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