Senior Manager, Clinical Operations

Harmony Biosciences LLC • Plymouth Meeting, PA

4d • Hybrid

About The Position

Harmony Biosciences is recruiting for a Senior Manager, Clinical Operations in our Plymouth Meeting, PA location. In this role you will be responsible for the planning and execution of all aspects of clinical trial conduct including site selection, 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. This role provides operational leadership for clinical studies and works cross-functionally with clinical teams, vendors, and investigators to ensure successful study delivery.

Requirements

• Bachelor’s degree required; Masters degree is preferred
• 6+ years of experience required in clinical research in the pharmaceutical/research industry leading complex clinical research deliverables in a multi-disciplinary, cross-functional environment
• Experience in more than one therapeutic area is required. Experience working in epilepsy is a plus
• 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

Nice To Haves

• Masters degree is preferred
• Experience working in epilepsy is a plus

Responsibilities

• Leads the operational planning and execution of Phase I-III clinical trials.
• Provides support with project completion according to overall development plan, and in compliance with all regulations, guidance, and health authority expectations.
• Develop and maintain clinical study timelines, milestones, and budgets.
• 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.
• Manage relationships with Contract Research Organization (CROs), and other vendors.
• Review vendor deliverables and performance metrics.
• 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 and external 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.
• Support regulatory submissions and interactions with regulatory authorities.
• Ensure proper documentation in Trial Master File (TMF).

Benefits

• 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 eight consecutive years based on our positive, values-based company culture

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level