OPT Clinical Data Specialist Jobs
Clinical Data Specialist jobs are a strong fit for F-1 OPT students with backgrounds in clinical research, biostatistics, or health informatics. Most roles qualify as STEM OPT extensions, giving you up to 36 months of work authorization. Employers in pharma, CROs, and academic medical centers actively hire OPT candidates for data entry, validation, and EDC management work.
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Location: Libertyville
Department: Clinical Affairs
Summary
The Specialist, Clinical Data Management (CDM) is a leader in supporting clinical studies for Hollister Incorporated medical device products and services. The CDM leads all aspects of clinical data management from study planning to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer. The CDM regularly collaborates with Global Clinical Affairs (GCA) study team members (Clinical Project Management, Biostatistics, Clinical Operations, Clinical Scientist) and cross-functional departments to ensure high data quality. The position operates under minimal supervision and independently evaluates, selects, and applies data management practices to a variety of research projects.
Responsibilities
Design and Planning
- Lead the development of data management sections of clinical protocol and corresponding Case Report Forms (CRFs).
- Develop and maintain data management essential documentation for the Trial Master File including, but not limited to; Data Management Plan, study-specific monitoring guidelines, edit checks, and user access forms, ensuring compliance with regulatory requirements.
- Support each clinical study and project team by ensuring data management plans, questionnaire development, and data handling activities are aligned to support the study objectives.
- Participate in study team meetings.
EDC Administration
- Design and program clinical study databases in EDC System including but not limited to CRFs, edit checks, data dictionaries, queries/alerts, and managing user roles based on the clinical protocol.
- Lead User Acceptance Testing (UAT) to validate build specifications.
- Train clinical research personnel on the study-specific CRF, EDC/ePRO, and other project related items as needed.
- Lead database clean, lock, export, and archiving activities.
- Oversee data management vendor relationships including EDC partners and CROs supporting DM tasks.
- Continuously assess and enhance the EDC systems to improve efficiency and data quality.
Data Monitoring
- Monitor clinical data to resolve queries and data discrepancies throughout each study according to Clinical Protocol and/or Data Management Plan.
- Coordinates AE/DD reconciliation with PI.
- Identify and communicate data issues and/or query trends to study team and/or management.
- Assist with developing metrics on study progress and routinely report out to study team and management.
Compliance and Process
- Ensure data management activities comply with Good Clinical Practice (GCP), regulatory requirements, and internal standard operating procedures.
- Contribute to the maintenance of GCA’s data management procedures and work instructions.
- Responsible for leading or collaborating on process improvement initiatives within department.
- Meet study timelines with a high degree of quality.
- Other duties as needed or required.
Essential Functions of the Role
- Communicate effectively via email, phone, and virtual platforms.
- Prepare reports and dashboards for internal stakeholders.
- Ensure data accuracy and confidentiality in compliance with company and legal standards.
- Manage multiple priorities and deadlines in a fast-paced environment.
- Demonstrate initiative in identifying process improvements or automation opportunities.
- Serve as a point of contact for internal and external stakeholders.
- Resolve inquiries and issues with professionalism and discretion.
- Adhere to company policies, including those related to ADA, data privacy, and ethics.
- Maintain secure handling of sensitive information.
Education & Work Requirements
- Bachelor's Degree with 2-5 years of related experience.
Education & Work Preferences
- Minimum of 2 years EDC database programming and Data Monitoring experience.
- Minimum of 2 years medical device and/or pharmaceutical clinical research experience.
- Certified Clinical Data Manager (CCDM) via SCDM or similar preferred.
- Equivalent combination of education, training and work experience may be accepted in lieu of degree.
- Experience with EDC Systems (e.g. Medrio, Clinpal, Medidata Rave, etc.) required.
- Understanding of clinical research regulations required.
- Experience in questionnaire development, database structure, and data management processes.
- Experience with Microsoft Suite Applications (Word, PowerPoint, Excel, Teams).
- Knowledge relating to continence care, critical care and/or ostomy a plus.
Competencies
- Be Agile - Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles.
- Be Customer Centric - Considers the needs, experiences and feedback of customers in all we do.
- Be People-Focused - Builds trust and collaborates with an inclusive and empathetic approach.
- Be Performance Driven - Operates with an ownership mindset, driving meaningful outcomes.
- Live The Schneiders’ Legacy, Our Noble Purpose - Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles.
Benefits Statement
Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.
- The anticipated base pay range for this position is $77,000 - $120,000 yearly. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.
- If applicable: This position is also eligible to participate in the Hollister Secure Start Bonus Plan.
- The Company’s health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.
- The Company’s 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants “safe harbor” matching contributions.
- The Company’s paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
- The Company’s additional benefits include: education assistance and adoption assistance benefit programs.
About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.
EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Job Req ID: 36304
We Make Life More Rewarding and Dignified
Location: Libertyville
Department: Clinical Affairs
Summary
The Specialist, Clinical Data Management (CDM) is a leader in supporting clinical studies for Hollister Incorporated medical device products and services. The CDM leads all aspects of clinical data management from study planning to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer. The CDM regularly collaborates with Global Clinical Affairs (GCA) study team members (Clinical Project Management, Biostatistics, Clinical Operations, Clinical Scientist) and cross-functional departments to ensure high data quality. The position operates under minimal supervision and independently evaluates, selects, and applies data management practices to a variety of research projects.
Responsibilities
Design and Planning
- Lead the development of data management sections of clinical protocol and corresponding Case Report Forms (CRFs).
- Develop and maintain data management essential documentation for the Trial Master File including, but not limited to; Data Management Plan, study-specific monitoring guidelines, edit checks, and user access forms, ensuring compliance with regulatory requirements.
- Support each clinical study and project team by ensuring data management plans, questionnaire development, and data handling activities are aligned to support the study objectives.
- Participate in study team meetings.
EDC Administration
- Design and program clinical study databases in EDC System including but not limited to CRFs, edit checks, data dictionaries, queries/alerts, and managing user roles based on the clinical protocol.
- Lead User Acceptance Testing (UAT) to validate build specifications.
- Train clinical research personnel on the study-specific CRF, EDC/ePRO, and other project related items as needed.
- Lead database clean, lock, export, and archiving activities.
- Oversee data management vendor relationships including EDC partners and CROs supporting DM tasks.
- Continuously assess and enhance the EDC systems to improve efficiency and data quality.
Data Monitoring
- Monitor clinical data to resolve queries and data discrepancies throughout each study according to Clinical Protocol and/or Data Management Plan.
- Coordinates AE/DD reconciliation with PI.
- Identify and communicate data issues and/or query trends to study team and/or management.
- Assist with developing metrics on study progress and routinely report out to study team and management.
Compliance and Process
- Ensure data management activities comply with Good Clinical Practice (GCP), regulatory requirements, and internal standard operating procedures.
- Contribute to the maintenance of GCA’s data management procedures and work instructions.
- Responsible for leading or collaborating on process improvement initiatives within department.
- Meet study timelines with a high degree of quality.
- Other duties as needed or required.
Essential Functions of the Role
- Communicate effectively via email, phone, and virtual platforms.
- Prepare reports and dashboards for internal stakeholders.
- Ensure data accuracy and confidentiality in compliance with company and legal standards.
- Manage multiple priorities and deadlines in a fast-paced environment.
- Demonstrate initiative in identifying process improvements or automation opportunities.
- Serve as a point of contact for internal and external stakeholders.
- Resolve inquiries and issues with professionalism and discretion.
- Adhere to company policies, including those related to ADA, data privacy, and ethics.
- Maintain secure handling of sensitive information.
Education & Work Requirements
- Bachelor's Degree with 2-5 years of related experience.
Education & Work Preferences
- Minimum of 2 years EDC database programming and Data Monitoring experience.
- Minimum of 2 years medical device and/or pharmaceutical clinical research experience.
- Certified Clinical Data Manager (CCDM) via SCDM or similar preferred.
- Equivalent combination of education, training and work experience may be accepted in lieu of degree.
- Experience with EDC Systems (e.g. Medrio, Clinpal, Medidata Rave, etc.) required.
- Understanding of clinical research regulations required.
- Experience in questionnaire development, database structure, and data management processes.
- Experience with Microsoft Suite Applications (Word, PowerPoint, Excel, Teams).
- Knowledge relating to continence care, critical care and/or ostomy a plus.
Competencies
- Be Agile - Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles.
- Be Customer Centric - Considers the needs, experiences and feedback of customers in all we do.
- Be People-Focused - Builds trust and collaborates with an inclusive and empathetic approach.
- Be Performance Driven - Operates with an ownership mindset, driving meaningful outcomes.
- Live The Schneiders’ Legacy, Our Noble Purpose - Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles.
Benefits Statement
Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.
- The anticipated base pay range for this position is $77,000 - $120,000 yearly. The actual salary varies based on applicant's location, education, experience, skills, abilities, and other legitimate business factors.
- If applicable: This position is also eligible to participate in the Hollister Secure Start Bonus Plan.
- The Company’s health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.
- The Company’s 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants “safe harbor” matching contributions.
- The Company’s paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
- The Company’s additional benefits include: education assistance and adoption assistance benefit programs.
About Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.
EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Job Req ID: 36304
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Get Access To All JobsTips for Finding OPT Sponsorship as a Clinical Data Specialist
Target CROs and pharma companies first
Contract research organizations like large pharma and biotech firms hire Clinical Data Specialists at scale and have established OPT and H-1B visa sponsorship pipelines. These employers process visa sponsorship routinely and are far less likely to reject your application over work authorization concerns.
Confirm your degree qualifies for STEM OPT
Clinical Data Specialist roles typically fall under STEM OPT if your degree is in biostatistics, health informatics, computer science, or a life science. Verify your program's CIP code with your DSO before applying, since your 24-month STEM extension eligibility depends entirely on this classification.
Lead with your EDC and clinical systems experience
Proficiency in Medidata Rave, Oracle Clinical, or Veeva Vault is a concrete differentiator that reduces employer hesitation around sponsorship. Specialized technical skills make the hiring decision about your qualifications, not your visa status, which shifts the conversation in your favor.
Apply before your OPT start date approaches
Hiring managers need lead time to clear legal and HR approval for OPT candidates. Starting your search at least three to four months before your authorization begins gives employers enough runway to process your paperwork without feeling rushed into a decision about sponsorship.
Address OPT directly and briefly in your cover letter
State your OPT authorization period and STEM extension eligibility in one sentence rather than avoiding the topic. Employers who see a clear 36-month window understand the timeline upfront and are more likely to proceed than those who discover work authorization details late in the process.
Use Migrate Mate to filter for OPT-friendly employers
Searching broadly wastes time on employers who never sponsor. Migrate Mate surfaces Clinical Data Specialist roles from companies with a verified history of OPT and visa sponsorship, so your applications go to employers already open to hiring international candidates in this field.
Clinical Data Specialist OPT: Frequently Asked Questions
Does a Clinical Data Specialist role qualify for the STEM OPT extension?
It depends on your degree, not the job title. If your degree is in biostatistics, health informatics, bioinformatics, computer science, or a qualifying life science with a STEM-designated CIP code, you likely qualify for the 24-month STEM extension on top of your 12-month standard OPT. Confirm your CIP code with your DSO before applying to roles, since this determines your total authorized work period.
Which types of employers are most likely to hire Clinical Data Specialists on OPT?
Contract research organizations, large pharmaceutical companies, biotechnology firms, and academic medical centers with clinical trial units are the most consistent OPT hirers in this field. These employers run ongoing clinical data operations that require specialized skills, and many have existing immigration counsel and HR processes for handling OPT work authorization. Migrate Mate filters specifically for employers with a sponsorship track record in clinical and life science roles.
Can I work as a Clinical Data Specialist as an independent contractor on OPT?
No. OPT requires a formal employer-employee relationship. You must be hired as a W-2 employee, not as a 1099 independent contractor. USCIS requires that your employer have the right to supervise and control your work. Contract or freelance arrangements do not satisfy this requirement and could jeopardize your OPT status and any future STEM extension eligibility.
What happens to my OPT status if my clinical research contract ends between projects?
Standard OPT allows a cumulative 90 days of unemployment across the full 12-month period. If you receive a STEM OPT extension, you get an additional 60 days, for a total of 150 days across the combined period. Gaps between clinical contracts count against this limit, so tracking your unemployment days carefully is important. Securing your next role before a contract ends is strongly advisable to protect your status.
Do I need to report a new Clinical Data Specialist job to my DSO while on OPT?
Yes. Any change in employer, position, or work location must be reported to your DSO within 10 days, and your DSO updates your record in SEVIS accordingly. For STEM OPT specifically, you must also submit a formal training plan with each new employer. Skipping these reporting steps is one of the most common compliance mistakes OPT students make and can affect your immigration record.