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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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Senior Associate, Trial Disclosure will be responsible for providing writing support to clinical trial registration and results postings including scientific study results and or protocol/results lay summaries and meeting required deadlines. Also responsible for the planning and execution of clinical drug trial registrations per the applicable regulatory requirements. The Senior Associate, Trial Disclosure Associate will also support Agency Disclosure activities, companywide Redaction/Anonymization of clinical documents for public disclosure and Access To Data processes.
Responsibilities
- Completes writing activities to assist in ensuring timely disclosure of accurate, consistent, aligned and complete information globally.
- Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area.
- Operationalizes changes in regulatory requirements via participation in the development and implementation of Standard Operating Procedures (SOPs)/processes, creating efficiency improvements/system automation and communication and training activities.
- Communicates deliverables, writing process and timelines effectively across functional areas and within department to accomplish project objectives.
- Coordinates the review, approval, and other appropriate functions involved with the registration and writing of clinical trial results public postings and Agency Disclosure activities.
- Accountable for completing the assigned studies within established timelines and with an appropriate quality level. Held accountable for driving writing projects and registration activities to timely completion.
- Identifies conflicts and resolves or elevates them to management to ensure resolution.
- Provides writing support for unique registrations to global registries or websites, includes non-interventional safety studies.
- Writes scientific study results and/or protocol/result lay summaries to registries and websites for multiple therapeutic areas with more complex study designs per global registry requirements.
- Supports anonymization of Protected Personal Data (PPD) and redaction of Commercially Confidential Information (CCI) in clinical documents for submission to and public release by regulatory agencies.
- Supports companywide Redaction/Anonymization of clinical documents for public disclosure and Access To Data processes.
Qualifications
- Bachelor's degree (BA/BS) from an accredited college or university is required, preferably in a health or biological science field.
- 3-4 years experience in clinical trial registries, regulatory agency transparency or drug development with a clinical research, quality or regulatory background.
- Relevant industry experience in medical writing in the healthcare industry or academia preferred; American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical. 1-3 years of writing experience preferred.
- Knowledge of generally accepted project management practices. Demonstrated success in managing broad scope projects involving cross-functional teamwork.
- Excellent communication (written and verbal), organization, planning, execution, and team leadership skills are required. Relationship management, communication ability, influencing skills required.
- Ability to successfully operate in an international environment and experience building effective working relationships across geographic locations.
- Working knowledge of registration / results / lay summary / agency disclosure requirements.
- Experienced in working in Excel, Word and other systems.
- Ability to assimilate and interpret scientific content and translate information for appropriate audience.
- Superior attention to detail. Ability to independently prioritize daily responsibilities and meet deadlines. Strong working knowledge of global registration / results / lay summary / agency disclosure requirements.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Senior Associate, Trial Disclosure will be responsible for providing writing support to clinical trial registration and results postings including scientific study results and or protocol/results lay summaries and meeting required deadlines. Also responsible for the planning and execution of clinical drug trial registrations per the applicable regulatory requirements. The Senior Associate, Trial Disclosure Associate will also support Agency Disclosure activities, companywide Redaction/Anonymization of clinical documents for public disclosure and Access To Data processes.
Responsibilities
- Completes writing activities to assist in ensuring timely disclosure of accurate, consistent, aligned and complete information globally.
- Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area.
- Operationalizes changes in regulatory requirements via participation in the development and implementation of Standard Operating Procedures (SOPs)/processes, creating efficiency improvements/system automation and communication and training activities.
- Communicates deliverables, writing process and timelines effectively across functional areas and within department to accomplish project objectives.
- Coordinates the review, approval, and other appropriate functions involved with the registration and writing of clinical trial results public postings and Agency Disclosure activities.
- Accountable for completing the assigned studies within established timelines and with an appropriate quality level. Held accountable for driving writing projects and registration activities to timely completion.
- Identifies conflicts and resolves or elevates them to management to ensure resolution.
- Provides writing support for unique registrations to global registries or websites, includes non-interventional safety studies.
- Writes scientific study results and/or protocol/result lay summaries to registries and websites for multiple therapeutic areas with more complex study designs per global registry requirements.
- Supports anonymization of Protected Personal Data (PPD) and redaction of Commercially Confidential Information (CCI) in clinical documents for submission to and public release by regulatory agencies.
- Supports companywide Redaction/Anonymization of clinical documents for public disclosure and Access To Data processes.
Qualifications
- Bachelor's degree (BA/BS) from an accredited college or university is required, preferably in a health or biological science field.
- 3-4 years experience in clinical trial registries, regulatory agency transparency or drug development with a clinical research, quality or regulatory background.
- Relevant industry experience in medical writing in the healthcare industry or academia preferred; American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical. 1-3 years of writing experience preferred.
- Knowledge of generally accepted project management practices. Demonstrated success in managing broad scope projects involving cross-functional teamwork.
- Excellent communication (written and verbal), organization, planning, execution, and team leadership skills are required. Relationship management, communication ability, influencing skills required.
- Ability to successfully operate in an international environment and experience building effective working relationships across geographic locations.
- Working knowledge of registration / results / lay summary / agency disclosure requirements.
- Experienced in working in Excel, Word and other systems.
- Ability to assimilate and interpret scientific content and translate information for appropriate audience.
- Superior attention to detail. Ability to independently prioritize daily responsibilities and meet deadlines. Strong working knowledge of global registration / results / lay summary / agency disclosure requirements.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
See all 136+ 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.