Manager, Clinical Operations

Harmony Biosciences is recruiting for a Manager, Clinical Trial Operations . In this role you will manage all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations / ICH guidelines.

Responsibilities include but are not limited to :

• Provides support with project completion according to overall development plan, and in compliance with all regulations, guidance, and health authority expectations.
• Oversees clinical trial conduct including feasibility, study start-up, enrollment, study conduct and close-out.
• Collaborates with the department, cross-functional teams, and external service providers that directly contribute to key study activities and milestones.
• Prepares and reviews study-related and essential clinical study documentation. Provides oversight and guidance if some tasks are delegated to a Clinical Trial Associate.
• Proactively identifies potential study risks and recommends / implements solutions.
• Communicates and escalates issues appropriately.
• Ensures clinical data from sites are of quality and delivered in accordance with expectations.
• Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
• Ensure the Clinical Trial Management System is complete and up to date for assigned studies.
• Prepares metrics and updates for management, as assigned.
• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
• Serves as a liaison and resource for investigational sites.
• Participates in the review and implementation of departmental SOPs and processes.
• Participates in study-level review to support data quality and integrity.

Qualifications :

Physical demands and work environment :

What can Harmony offer you?

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Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com

Harmony Biosciences is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity / expression, age, disability, genetic information, military service, covered / protected veteran status or any other federal, state or local protected class.

Recruitment agencies please note : Harmony Biosciences will only accept applications from agencies / business partners that have been invited to work on a specific role. Candidate Resumes / CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

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