Clinical Trial Manager Jobs for OPT Students
Clinical Trial Manager jobs are a strong fit for F-1 OPT students with degrees in life sciences, public health, or a related field. Most roles qualify as STEM OPT extensions, giving you up to three years of work authorization while you build sponsor relationships with contract research organizations and pharmaceutical companies.
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Get Access To All JobsJob Type: Officer of Administration
Bargaining Unit:
Regular/Temporary: Regular
End Date if Temporary:
Hours Per Week: 35
Standard Work Schedule:
Building:
Salary Range: $100,000 - $110,000
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Position Summary
The Multi-Center Clinical Trials Manager will be an integral member of the senior leadership team within the Clinical Protocol & Data Management (CPDM) Office of the Herbert Irving Comprehensive Cancer Center (HICCC). The candidate is responsible for providing managerial oversight for CUMC sponsored multicenter trials including protocol development, site activations, data management, regulatory processing, auditing/monitoring, specimen collection, data analysis and publication. Assist in the development of multicenter clinical trial budgets, sub-site invoicing/payments and research fund accounting. Help facilitate multicenter trials confidentiality disclosure agreements and clinical trial contracts. The candidate is responsible for implementing policies and procedures that improve and stimulate the work environment, which is a key aspect of this position. The candidate is responsible for assessing workloads, competently, and assigning projects appropriately to ensure positive outcomes. The candidate must recognize and identify opportunities for continued improvement and operational efficiencies. In addition, the reputation of the institution relies on the quality of the clinical research team; this reputation in turn ensures continued positive relationships with private industry and other external agencies.
This position reports to the Assistant Director, Clinical Research Operations and is primarily based out of 400 Kelby Street, Fort Lee, NJ.
Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.
Responsibilities
- Coordinating the Multi-Center Trials Operational activities of the CPDM, while providing supervision and delegation of work assignments and evaluation of the CPDM Multi-Center Coordinators; creating and promoting professional development opportunities (both internally and externally) for staff; Implementing processes and that improve, streamline, and stimulate the work environment; continually assessing trial complexity/workload and resource allocation to ensure patient safety and clinical research excellence; ensuring and promoting positive relationships and outcomes with private industry and other external agencies; assists the departmental finance administrator in maintaining accurate and up-to-date invoice statuses/payments across MCT trials.
- Posts/justifies new and replacement positions, screens applicants, on-boards and trains staff (protocol, university, departmental training). Liaises with the HICCC HR representative for scheduling of HR-related functions. Makes appropriate salary recommendations for new and existing staff based on prior experience and conducts annual staff performance reviews (including establishing and continually monitoring FY goals).
- Monitors, directs, and supervises staff in a manner that facilitates efficient level of operations. Determines workloads and protocol assignments. Develops quality control mechanisms to ensure accurate regulatory submission practices on behalf of the department. Assists with IND management/submission/oversight on behalf of all applicable Sponsor-Investigator held MCT INDs.
- Provides MCT protocol management and research/regulatory expertise by participating in discussions pertinent to projects at collaborative research meetings. Organizes projects and collaborates with multidisciplinary team and other health care personnel as needed to complete assigned tasks. Attends regularly scheduled conferences and meetings.
- Assist the CPDM Leadership Team in developing, implementing, and executing departmental Standard Operating Procedures (SOPs). Develop standardized forms, study tools, and promote cross-coverage with CPDM Leadership to ensure coverage, provide appropriate staff updates, in-services, trainings, etc.
- Collaborates with all members of the office with special attention to compliance and monitoring of MCT portfolio.
- Provides protocol management and research expertise by participating in discussions pertinent to projects at collaborative research meetings.
- Collaborates with investigators to develop multicenter protocols including budget development.
- Perform other related duties and responsibilities as assigned/requested.
Minimum Qualifications
Bachelor's Degree or equivalent plus four years of related experience.
Preferred Qualifications
- At least one year of supervisory experience. Experience in clinical research setting necessary, including a thorough understanding of ICH-GCP and CFR guidelines.
- Excellent interpersonal and organizational skills.
- Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).
- Preferred certification as a Clinical Research Professional through a national accrediting body such as ACRP, RAPS, PRIM&R CIP, and/or SOCRA.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Job Type: Officer of Administration
Bargaining Unit:
Regular/Temporary: Regular
End Date if Temporary:
Hours Per Week: 35
Standard Work Schedule:
Building:
Salary Range: $100,000 - $110,000
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Position Summary
The Multi-Center Clinical Trials Manager will be an integral member of the senior leadership team within the Clinical Protocol & Data Management (CPDM) Office of the Herbert Irving Comprehensive Cancer Center (HICCC). The candidate is responsible for providing managerial oversight for CUMC sponsored multicenter trials including protocol development, site activations, data management, regulatory processing, auditing/monitoring, specimen collection, data analysis and publication. Assist in the development of multicenter clinical trial budgets, sub-site invoicing/payments and research fund accounting. Help facilitate multicenter trials confidentiality disclosure agreements and clinical trial contracts. The candidate is responsible for implementing policies and procedures that improve and stimulate the work environment, which is a key aspect of this position. The candidate is responsible for assessing workloads, competently, and assigning projects appropriately to ensure positive outcomes. The candidate must recognize and identify opportunities for continued improvement and operational efficiencies. In addition, the reputation of the institution relies on the quality of the clinical research team; this reputation in turn ensures continued positive relationships with private industry and other external agencies.
This position reports to the Assistant Director, Clinical Research Operations and is primarily based out of 400 Kelby Street, Fort Lee, NJ.
Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.
Responsibilities
- Coordinating the Multi-Center Trials Operational activities of the CPDM, while providing supervision and delegation of work assignments and evaluation of the CPDM Multi-Center Coordinators; creating and promoting professional development opportunities (both internally and externally) for staff; Implementing processes and that improve, streamline, and stimulate the work environment; continually assessing trial complexity/workload and resource allocation to ensure patient safety and clinical research excellence; ensuring and promoting positive relationships and outcomes with private industry and other external agencies; assists the departmental finance administrator in maintaining accurate and up-to-date invoice statuses/payments across MCT trials.
- Posts/justifies new and replacement positions, screens applicants, on-boards and trains staff (protocol, university, departmental training). Liaises with the HICCC HR representative for scheduling of HR-related functions. Makes appropriate salary recommendations for new and existing staff based on prior experience and conducts annual staff performance reviews (including establishing and continually monitoring FY goals).
- Monitors, directs, and supervises staff in a manner that facilitates efficient level of operations. Determines workloads and protocol assignments. Develops quality control mechanisms to ensure accurate regulatory submission practices on behalf of the department. Assists with IND management/submission/oversight on behalf of all applicable Sponsor-Investigator held MCT INDs.
- Provides MCT protocol management and research/regulatory expertise by participating in discussions pertinent to projects at collaborative research meetings. Organizes projects and collaborates with multidisciplinary team and other health care personnel as needed to complete assigned tasks. Attends regularly scheduled conferences and meetings.
- Assist the CPDM Leadership Team in developing, implementing, and executing departmental Standard Operating Procedures (SOPs). Develop standardized forms, study tools, and promote cross-coverage with CPDM Leadership to ensure coverage, provide appropriate staff updates, in-services, trainings, etc.
- Collaborates with all members of the office with special attention to compliance and monitoring of MCT portfolio.
- Provides protocol management and research expertise by participating in discussions pertinent to projects at collaborative research meetings.
- Collaborates with investigators to develop multicenter protocols including budget development.
- Perform other related duties and responsibilities as assigned/requested.
Minimum Qualifications
Bachelor's Degree or equivalent plus four years of related experience.
Preferred Qualifications
- At least one year of supervisory experience. Experience in clinical research setting necessary, including a thorough understanding of ICH-GCP and CFR guidelines.
- Excellent interpersonal and organizational skills.
- Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).
- Preferred certification as a Clinical Research Professional through a national accrediting body such as ACRP, RAPS, PRIM&R CIP, and/or SOCRA.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
How to Get Visa Sponsorship as a Clinical Trial Manager
Target CROs and pharmaceutical companies with established OPT pipelines
Contract research organizations like ICON, Syneos Health, and Parexel regularly hire international candidates. These employers already understand OPT timelines and reporting requirements, making them more likely to support your authorization without lengthy internal approvals.
Confirm your degree qualifies for STEM OPT extension
Clinical Trial Manager roles typically fall under CIP codes for biological sciences, public health, or biomedical engineering. Verify your specific degree program is on the STEM OPT designated list before accepting a role, since this determines your total work authorization window.
Address OPT timelines proactively in applications
Most clinical trial hiring cycles run 6 to 10 weeks. Apply early and mention your OPT end date in your initial outreach. Employers unfamiliar with STEM extension can plan ahead once they understand you have up to three years of continuous work authorization available.
Emphasize protocol and regulatory experience in your resume
Hiring managers for CTM roles screen heavily for ICH-GCP certification, protocol deviation management, and FDA or EMA regulatory familiarity. These credentials signal readiness for independent site management and make sponsorship conversations easier to initiate with risk-averse employers.
Negotiate sponsor commitment before your OPT expires
Start H-1B or O-1 sponsorship conversations at least 12 months before your OPT ends. Clinical trial employers who value continuity on long-running studies are often willing to sponsor rather than lose a manager mid-trial, especially after protocol training investment.
Leverage your university's DSO resources for employer education
Some hiring managers confuse OPT with CPT or assume sponsorship is required immediately. Your DSO can provide employer fact sheets explaining that OPT requires no petition or employer cost, removing a common objection before salary negotiations even begin.
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Get Access To All JobsFrequently Asked Questions
Do Clinical Trial Manager jobs qualify for the STEM OPT extension?
Most Clinical Trial Manager positions qualify for the 24-month STEM OPT extension if your degree is in a qualifying field such as biological sciences, public health, biomedical engineering, or a related discipline listed on the STEM OPT designated program list. You should confirm your specific CIP code with your DSO before accepting an offer, since the job title alone does not determine eligibility.
What should I know about the 90-day unemployment limit while job searching?
F-1 OPT students are limited to 90 cumulative days of unemployment during the standard OPT period. If you receive the STEM extension, you get an additional 60 days, for 150 days total across the full OPT period. Clinical trial hiring cycles can run 6 to 10 weeks, so apply as early as possible after graduation and track your unemployment days carefully to avoid status violations.
Can I work as a Clinical Trial Manager on a freelance or contract basis during OPT?
Yes, OPT permits self-employment and independent contracting, but the work must be directly related to your degree field and average at least 20 hours per week. If you take contract assignments through a CRO or staffing agency, ensure the arrangement is documented and that your role genuinely aligns with your degree program, as DSOs may review this during reporting.
Where can I find Clinical Trial Manager jobs that are open to OPT candidates?
Migrate Mate is built specifically for F-1 OPT and international students, so every listing on the platform is filterable by visa sponsorship and OPT-friendly status. Searching there saves time compared to manually screening generic job postings that rarely disclose work authorization requirements upfront.
What reporting requirements apply to OPT students working as Clinical Trial Managers?
You must report any change in employer, job title, work address, or employment status to your DSO within 10 days, and your DSO updates SEVIS accordingly. For STEM OPT extension holders, your employer must also submit a formal training plan using Form I-983 and conduct self-evaluations at the six-month and annual marks. Failing to report changes on time can jeopardize your status even if the underlying employment is valid.
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