Clinical Trial Administration Associate bei OCUGEN OPCO INC

Description

Job Purpose

The Clinical Trial Administration Associate provides a combination of clinical trial support and administrative assistance to ensure efficient execution of clinical studies and smooth operation of the clinical operations team. This role contributes directly to the planning, execution, and oversight of studies while also handling administrative tasks that support both departmental and company-wide activities.

Responsibilities

Clinical Trial Support (approx. 65%)

• Assists in the operational execution of clinical studies to ensure delivery within agreed timelines and budget while maintaining compliance with protocols, SOPs, ICH/GCP, and regulatory requirements.
• Supports preparation and review of study-related documents such as informed consent forms, study plans, investigator meeting materials, case report forms, and clinical study reports.
• Tracks study progress, enrollment projections, and deliverables, escalating risks or delays to management.
• Helps maintain the Trial Master File (TMF), ensuring documents are filed, reconciled, and archived accurately.
• Coordinates site initiation, monitoring, and closure activities in collaboration with CRAs.
• Provides administrative and operational support during CRO/vendor identification, qualification, and management.
• Assists in preparing study budgets, forecasts, and financial tracking in collaboration with Finance.
• Ensures timely collection and delivery of data for internal and external review committees.

Administrative Support (approx. 35%)

• Provides general administrative support for the clinical operations team, including scheduling meetings, managing calendars, coordinating travel, and processing expense reports.
• Prepares agendas, minutes, and follow-ups for clinical and cross-functional meetings.
• Formats, proofreads, and distributes study-related documents and presentations.
• Maintains departmental trackers, databases, and project management tools.
• Serves as point of contact for vendors and internal stakeholders to streamline communications.
• Supports overall departmental organization, filing systems, and day-to-day logistics.

Qualifications

• BA/BS degree, preferably in life sciences or related field.
• 2–3 years of experience in clinical research, clinical operations, or administrative support within the biotech/pharmaceutical industry.
• Familiarity with GCPs, ICH, and FDA regulatory requirements preferred.
• Experience with eTMF, CTMS, and EDC systems a plus.
• Strong administrative and organizational skills; proven ability to handle multiple priorities.
• Excellent communication skills and a team-oriented, collaborative mindset.
• High attention to detail and commitment to accuracy and quality.

Working Conditions

This position operates in an office setting, in person Monday through Friday. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Physical requirements

This is a mostly sedentary role

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.