Clinical Operations Manager

4 days ago

Plymouth Meeting, Pennsylvania, United States Harmony Biosciences LLC Full time
Job Title: Clinical Operations Manager

Harmony Biosciences is seeking a highly skilled Clinical Operations Manager to join our team in Plymouth Meeting, PA. As a key member of our clinical operations team, you will be responsible for managing all aspects of clinical trial conduct, including study start-up, enrollment, oversight, maintenance, reporting, and close-out.

Responsibilities:
  • Provide support with project completion according to overall development plan, and in compliance with all regulations, guidance, and health authority expectations.
  • Oversee clinical trials, including feasibility, study start-up, enrollment, study conduct, and close-out.
  • Collaborate with the department, cross-functional teams, and external service providers that directly contribute to key study activities and milestones.
  • Prepare and review study-related and essential clinical study documentation. Provide oversight and guidance to Clinical Trial Associates, as needed.
  • Proactively identify potential study risks and recommend/implement solutions.
  • Communicate and escalate issues appropriately.
  • Ensure clinical data from sites are of quality and delivered in accordance with expectations.
  • Participate 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.
  • Prepare metrics and updates for management, as assigned.
  • Organize and manage internal team meetings, investigator meetings, and other trial-specific meetings.
  • Serve as a liaison and resource for investigational sites.
  • Participate in the review and implementation of departmental SOPs and processes.
  • Participate in study-level review to support data quality and integrity.
Qualifications:
  • Bachelor's degree required; Master's 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 the 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 the ability to identify appropriate solutions.
  • Effective written and verbal communication skills.
  • Proficient in the use of Microsoft Office Suite.
What We Offer:
  • 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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