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Unblinded Study Jobs (NOW HIRING)

Ocugen Inc

Senior Clinical Trial Manager

Malvern, PA · On-site

Unblinded Study Responsibilities * Serve in an unblinded operational role when required, maintaining strict confidentiality and protocol compliance. Budget and Resource Discipline * Collaborate with ...

New

Astera

Clinical Research Coordinator

Toms River, NJ

$29/hr

If applicable, able to prepare blinded and unblinded study drugs. * If applicable, act as primary coordinators for unblinded team. Qualifications: * A Bachelor's degreeor equivalent working ...

Astera

Clinical Research Coordinator

Toms River, NJ · On-site

$29 - $33/hr

If applicable, able to prepare blinded and unblinded study drugs. * If applicable, act as primary coordinators for unblinded team. Qualifications: * A Bachelor's degree or equivalent working ...

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Unblinded Study information

What is an unblinded study?

An unblinded study is a type of clinical research in which both the researchers and participants know which treatment or intervention is being administered. This contrasts with blinded studies, where one or both parties are unaware of the treatment allocation to reduce bias. Unblinded studies are often used when blinding is not feasible, such as in surgical interventions or certain behavioral studies. While they are easier to conduct, unblinded studies can be more susceptible to bias, so results must be interpreted carefully.

What is the difference between Unblinded Study vs Data Analyst?

AspectUnblinded StudyData Analyst
CredentialsTypically requires clinical research training, certifications in Good Clinical Practice (GCP)Requires degrees in statistics, mathematics, or related fields; certifications like CAP or Microsoft Excel certifications are common
Work EnvironmentClinical research settings, hospitals, or research organizationsOffice environments, data centers, or remote work
Industry UsagePharmaceuticals, clinical research organizations, healthcareVarious industries including healthcare, finance, marketing

Unblinded Study professionals focus on clinical trial phases where treatment groups are revealed, requiring clinical knowledge. Data Analysts interpret data across industries, including healthcare, often working with large datasets. While both roles involve data handling, their environments, credentials, and industry applications differ significantly.

What are some common challenges faced by professionals working on unblinded studies, and how can they be addressed?

Professionals involved in unblinded studies often face challenges related to maintaining objectivity and minimizing bias, since both participants and researchers are aware of the treatment being administered. This can influence data collection and interpretation. To address these challenges, teams typically implement rigorous protocols, frequent training, and independent data monitoring. Additionally, clear documentation and adherence to Good Clinical Practice (GCP) help ensure data integrity and regulatory compliance throughout the study.

What are the key skills and qualifications needed to thrive as an unblinded study coordinator, and why are they important?

To thrive as an Unblinded Study Coordinator, you need a background in life sciences, clinical research experience, and knowledge of Good Clinical Practice (GCP) guidelines. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) tools, and relevant certifications like ACRP or SOCRA is typically required. Attention to detail, strong organizational skills, and effective communication are crucial soft skills for success in this role. These skills ensure protocol adherence, data integrity, and seamless collaboration with study teams in regulated clinical trial environments.
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Infographic showing various Unblinded Study job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, and 12% Part Time. Highlights an 71% In-person, and 29% Remote job distribution.

Senior Clinical Trial Manager

Ocugen Inc

Malvern, PA • On-site

Other

Posted 3 days ago

New

Job description

Position Summary
The Senior Clinical Trial Manager (Sr. CTM) is responsible for independently leading the operational management and execution of clinical trials from initiation through close-out. This role focuses on rigorous study execution, proactive risk identification, and strong coordination across clinical, regulatory, biometrics, and external partners.
The Sr. CTM leads complex or high-priority studies with minimal supervision, drives study start-up activities, and maintains strong engagement with investigators and study physicians. This role requires a hands-on, highly organized individual who is comfortable operating in a fast-changing, resource-constrained environment and who can drive execution through vendors, CROs, and internal teams.
Responsibilities
Clinical Execution and Delivery
  • Independently lead the planning, execution, and delivery of clinical studies in accordance with GCP/ICH guidelines, SOPs, and regulatory requirements.
  • Drive study timelines, enrollment execution, and operational milestones to meet program objectives.
  • Anticipate operational risks and implement mitigation strategies to prevent delays or quality issues.
  • Maintain clear visibility into timelines, dependencies, and critical paths across assigned studies.

Study Start-Up and Site Activation
  • Lead or significantly contribute to study start-up activities including site feasibility, vendor coordination, regulatory package readiness, and site activation timelines.
  • Support investigator selection, site qualification, and initiation activities to ensure efficient trial launch.

Physician and Investigator Engagement
  • Build and maintain effective working relationships with investigators and study physicians.
  • Support enrollment strategy, site performance, and investigator engagement to drive study progress.

Vendor and CRO Oversight
  • Serve as the primary operational contact for CROs and vendors, ensuring performance, timelines, and quality expectations are met.
  • Lead vendor governance discussions and hold vendors accountable for deliverables and issue resolution.

Systems, Documentation, and Inspection Readiness
  • Oversee completeness, quality, and inspection readiness of the eTMF.
  • Ensure timely filing and quality control of essential documents within Veeva eTMF and other clinical systems.
  • Support audit and inspection readiness activities, ensuring documentation and operational processes meet regulatory expectations.

Cross-Functional Collaboration
  • Partner closely with Clinical Development, Program Management, Biometrics, Regulatory, QA, and Finance to ensure studies remain aligned with program priorities and milestones.
  • Facilitate clear communication and rapid resolution of operational challenges across functions.

Unblinded Study Responsibilities
  • Serve in an unblinded operational role when required, maintaining strict confidentiality and protocol compliance.

Budget and Resource Discipline
  • Collaborate with Finance and Clinical leadership to forecast and monitor study budgets.

Identify risks to timelines, resources, or costs early and implement corrective actions.
Travel
  • Travel to investigator sites, meetings, and vendors as required to support study execution and oversight.

Continuous Improvement
  • Identify and implement process improvements to enhance study execution, timelines, and operational efficiency.

  • Bachelor's degree in life sciences or related field required; advanced degree a plus.
  • Minimum 7-10 years of clinical research experience in biotech or pharmaceutical settings, including experience managing clinical trials.
  • Demonstrated experience managing study timelines, vendors, and operational risks.
  • Strong knowledge of ICH-GCP, FDA, and international clinical trial regulations.
  • Experience with clinical trial systems including CTMS, EDC, and eTMF.
  • Experience with Veeva eTMF or comparable document management systems.
  • Experience supporting study start-up and site activation activities.
  • Demonstrated ability to operate independently, prioritize effectively, and drive execution in a fast-paced, changing environment.
  • Strong organizational, communication, and problem-solving skills.

Preferred
  • Experience in ophthalmology, advanced therapies, or small to mid-size biotech companies.
  • Experience working in an unblinded study environment.
  • Experience engaging investigators and study physicians directly.

Working Conditions
This position operates in an office setting when not traveling on business. Domestic and international travel may be required.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.
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About Ocugen

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

Malvern, PA, US

Year founded

2013

Social media

Twitter

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