Clinical Trial Assistant

About the Role

Harmony Biosciences is seeking a Clinical Trial Assistant based in Plymouth Meeting, PA. This position offers vital administrative, operational, and project-related support to Clinical Operations and cross-functional teams during the lifecycle of clinical trials. The role encompasses assisting with study start-up, managing site and vendor documentation, maintaining the trial master file (TMF), monitoring enrollment, supervising study conduct, and handling study close-out procedures. Ensuring the accuracy, efficiency, and regulatory compliance of clinical trial processes, documentation, and communications is essential.

Key Responsibilities

• Deliver administrative assistance to the clinical study team.
• Support Clinical Operations in the active management of ongoing studies.
• Help teams handle study-specific documentation and adhere to procedural guidelines.
• Organize, establish, and preserve clinical study documents systematically.
• Manage Data Collection Forms including logging, tracking, and quality control as appropriate.
• Participate in quality control audits and prepare for inspection readiness by reviewing clinical study documentation.
• Assist in creating and updating presentation slides for projects, departmental meetings, and sponsor presentations.
• Maintain clinical trial files, including reviewing electronic TMFs, tracking systems, and other related platforms.
• Oversee vendor and clinical site agreements, budget monitoring, and invoice reconciliation.
• Review regulatory documents in collaboration with relevant teams.
• Perform additional relevant tasks as assigned by management.
• Prepare and circulate communications, meeting agendas, minutes, and reports related to studies.

Qualifications

• Bachelor’s degree in Life Sciences, Biology, Healthcare, or a related scientific field is mandatory.
• Prior relevant experience through internships, cooperative programs, academic or clinical research, healthcare, or similar environments is preferred.
• Basic knowledge of clinical research, scientific methodology, and clinical trial procedures is desirable.
• Strong organizational skills with meticulous attention to detail and capability to handle multiple concurrent priorities.
• Excellent verbal and written communication abilities.
• Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook.

Physical and Work Environment Conditions

• Estimated domestic travel approximates 15% of job duties.
• The workplace environment is typically quiet.
• Occasional lifting or moving of items over 20 pounds is required.
• Close vision capabilities are necessary.
• Manual dexterity for usage of computers, tablets, and phones is essential.
• The role involves prolonged periods of sitting.

Employee Benefits

• Access to medical, vision, and dental coverage starting the first of the month post hire.
• Generous paid time off and designated company holidays.
• Company-paid disability and life insurance benefits.
• Participation in 401(k) retirement savings plan.
• Paid parental leave.
• Opportunity to join the Employee Stock Purchase Plan (ESPP).
• Wellness programs sponsored by the company.
• Professional growth and continuous learning initiatives.
• Recognition as a Great Place to Work® for eight consecutive years driven by strong company culture and values.

About Harmony Biosciences

Harmony Biosciences is a pharmaceutical organization headquartered in Plymouth Meeting, PA, founded in October 2017. Its mission focuses on delivering innovative therapies for individuals affected by rare neurological diseases who have unmet medical needs.

Equal Opportunity and Recruitment Information

Harmony Biosciences is committed to equal employment opportunities for all regardless of race, color, national origin, religion, gender, pregnancy status, marital status, sexual orientation, gender identity or expression, age, disability, genetic information, military or veteran status, and other protected classes in compliance with federal, state, and local laws.

Recruitment agencies should note that only invited agencies may submit candidates for specific roles; unsolicited submissions will not be compensated.