Manager, Clinical Operations

Harmony Biosciences is recruiting for a Manager, Clinical Operations in our Plymouth Meeting, PA location. In this role you will manage all aspects of clinical trial conduct including study start-up, enrollment, oversight, maintenance, reporting 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 trials 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 to Clinical Trial Associates, as needed.
• 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:

• Bachelor's degree required; Masters degree is preferred.
• 2+ years of experience managing epilepsy trials (global experience preferred) OR 4+ years of lead CRA experience leading complex clinical research deliverables in a multi-disciplinary, cross-functional environment. Epilepsy experience is required.
• Working knowledge of legal, compliance, and regulatory guidelines related to conduct of late-phase trials in the US and globally.
• Considers quality and attention to detail as fundamental and necessary attributes of all output and patient safety as an overarching responsibility.
• Strategic problem-solver with ability to identify appropriate solutions.
• Effective written and verbal communication skills.
• Proficient in the use of Microsoft Office Suite

Physical demands and work environment:

• Domestic travel around 10% will be required for this role.
• While performing the duties of this job, the noise level in the work environment is usually quiet.
• Specific vision abilities required by this job include: Close vision.
• Manual dexterity required to use computers, tablets, and cell phone.
• Continuous sitting for prolonged periods.

What can Harmony offer you?

• Medical, Vision and Dental benefits the first of the month following start date
• Generous paid time off and Company designated Holidays
• Company paid Disability benefits and Life Insurance coverage
• 401(k) Retirement Savings Plan
• Paid Parental leave
• Employee Stock Purchase Plan (ESPP)
• Company sponsored wellness programs
• Professional development initiatives and continuous learning opportunities
• A certified Great Place to Work for six consecutive years based on our positive, values-based company culture

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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, LLC 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.