OPT Clinical Trial Manager Jobs
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 JobsDIVISION OVERVIEW:
Acrotech Biopharma Inc. was formed as a global platform to commercialize innovative proprietary medications. The company aims to launch scientifically advanced products to address unmet needs and deliver value to patients as well as all healthcare stakeholders. Acrotech aspires to be a patient-focused, research-based organization that strives to launch treatments which are accessible to patients that need them.
Acrotech currently markets a portfolio of 5 oncology products including 2 of the leading products in Peripheral T-Cell Lymphoma (PTCL), which is a rare and aggressive blood cancer. We have also launched a novel drug for the treatment of chemotherapy-induced neutropenia (CIN).
JOB OVERVIEW:
The Clinical Trial Manager will lead key aspects of assigned clinical trial(s) and demonstrates a good level of knowledge of clinical methodologies, organizational, project management and leadership capabilities. The role works under the guidance and direction of the Clinical Program Lead. Ensures successful clinical trial planning, execution and delivery – within specified quality, time and cost parameters. Works to ensure adherence to a standardized approach to clinical trial management. Reviews, tracks and files study specific documents as well as creates and updates study specific reports. Exercises discretion and judgment in handling confidential information and will follow FDA regulations, ICH guidelines and GCP in all tasks.
Responsibilities:
- Acts as a regional lead for large global studies
- Contributes to the content and review of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF’s, monitoring visits reports etc. Coordinates and tracks the distribution and retrieval of documents.
- Assists in the set up and perform oversight of the electronic Trial Master File according to ICH-GCP, and company SOPs. Ensures all documentation is in a state of audit readiness. Prepares study related documents, i.e. clinical trial tools, trackers & templates etc.
- Coordinates with Supply Operations regarding drug forecasting and supply of study drug/comparator drug to sites
- Performs oversight of Central Lab and other ancillary vendors during start-up, conduct, and close-out. Assists with vendor management during the coordination of Investigator Meetings.
- Performs some administrative tasks to support Clinical Operations Department and team members as needed
- Demonstrates knowledge of sample collection, analysis process and sample reconciliation.
- Contributes to and reviews changes in scope and change orders
- Actively participates in the development of department initiatives; contributes ideas when asked on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations
QUALIFICATIONS - SKILLS & REQUIREMENTS:
- CRA experience and a minimum 3-5 years of direct clinical trial management experience
- Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
- A team player and ability to take initiative and lead
- Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within an organization
- Proficient written and verbal communication skills
EDUCATION & EXPERIENCE:
- Bachelor’s degree in a scientific or healthcare discipline is required; Master's degree preferred
Physical Requirements:
OFFICE POSITION - While performing the duties of this job the employee is required to:
- Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard; reach, stoop, kneel to install computer equipment
- Specific vision abilities required by this job include close vision requirements due to computer work
- Light to moderate lifting is required
- Moderate noise (i.e. business office with computers, phone, and printers, light traffic)
- Ability to sit at a computer terminal for an extended period of time
- Sedentary work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Additional Physical Requirements: No Additional Requirements
Blood/Fluid Exposure Risk: Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
DIVISION OVERVIEW:
Acrotech Biopharma Inc. was formed as a global platform to commercialize innovative proprietary medications. The company aims to launch scientifically advanced products to address unmet needs and deliver value to patients as well as all healthcare stakeholders. Acrotech aspires to be a patient-focused, research-based organization that strives to launch treatments which are accessible to patients that need them.
Acrotech currently markets a portfolio of 5 oncology products including 2 of the leading products in Peripheral T-Cell Lymphoma (PTCL), which is a rare and aggressive blood cancer. We have also launched a novel drug for the treatment of chemotherapy-induced neutropenia (CIN).
JOB OVERVIEW:
The Clinical Trial Manager will lead key aspects of assigned clinical trial(s) and demonstrates a good level of knowledge of clinical methodologies, organizational, project management and leadership capabilities. The role works under the guidance and direction of the Clinical Program Lead. Ensures successful clinical trial planning, execution and delivery – within specified quality, time and cost parameters. Works to ensure adherence to a standardized approach to clinical trial management. Reviews, tracks and files study specific documents as well as creates and updates study specific reports. Exercises discretion and judgment in handling confidential information and will follow FDA regulations, ICH guidelines and GCP in all tasks.
Responsibilities:
- Acts as a regional lead for large global studies
- Contributes to the content and review of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF’s, monitoring visits reports etc. Coordinates and tracks the distribution and retrieval of documents.
- Assists in the set up and perform oversight of the electronic Trial Master File according to ICH-GCP, and company SOPs. Ensures all documentation is in a state of audit readiness. Prepares study related documents, i.e. clinical trial tools, trackers & templates etc.
- Coordinates with Supply Operations regarding drug forecasting and supply of study drug/comparator drug to sites
- Performs oversight of Central Lab and other ancillary vendors during start-up, conduct, and close-out. Assists with vendor management during the coordination of Investigator Meetings.
- Performs some administrative tasks to support Clinical Operations Department and team members as needed
- Demonstrates knowledge of sample collection, analysis process and sample reconciliation.
- Contributes to and reviews changes in scope and change orders
- Actively participates in the development of department initiatives; contributes ideas when asked on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations
QUALIFICATIONS - SKILLS & REQUIREMENTS:
- CRA experience and a minimum 3-5 years of direct clinical trial management experience
- Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
- A team player and ability to take initiative and lead
- Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within an organization
- Proficient written and verbal communication skills
EDUCATION & EXPERIENCE:
- Bachelor’s degree in a scientific or healthcare discipline is required; Master's degree preferred
Physical Requirements:
OFFICE POSITION - While performing the duties of this job the employee is required to:
- Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard; reach, stoop, kneel to install computer equipment
- Specific vision abilities required by this job include close vision requirements due to computer work
- Light to moderate lifting is required
- Moderate noise (i.e. business office with computers, phone, and printers, light traffic)
- Ability to sit at a computer terminal for an extended period of time
- Sedentary work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Additional Physical Requirements: No Additional Requirements
Blood/Fluid Exposure Risk: Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
See all 146+ OPT Clinical Trial Manager Jobs
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Get Access To All JobsTips for Finding OPT 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 visa or O-1 visa 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.
Clinical Trial Manager OPT: Frequently 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.