- Responsible for the oversight of trial/program level operations for existing and/or future clinical studies, including but not limited to CRO/vendor identification, selection and oversight of contracted services to support Harmony clinical trials.
- Ongoing oversight of collaboration partners, including setting study goals, team training, development of trial budgets and implementation of a financial reconciliation process for clinical studies.
- Identify ways to accelerate project execution where possible while maintaining high quality standards.
- Provides contingencies and alternate approaches to deliverables associated with the lifecycle of a clinical trial.
- Responsible for facilitation of effective internal and external departmental relationships, efficient group functionality, new process and method evaluation, and achievement of clinical research department goals.
- Responsible for managing the strategy, design, development, and evaluation of the clinical plans and expediting the implementation of related clinical trials for the purpose of regulatory filing, obtaining outcomes data, and marketing efforts.
- Coordinate closely with cross-functional departments and departmental leaders (medical affairs, compliance, regulatory, etc.) to ensure optimal alignment of commercial goals, site operations, data monitoring and review, and safety surveillance and reporting.
- Establish and administer KPIs to ensure customer and company business needs are consistently achieved and provide timely information to executive management team to drive effective business strategies
- Participates in the development, review and implementation of departmental SOPs and processes.
- Performs other related duties as assigned by management.
- This position may have supervisory responsibilities for Harmony Clinical Operations personnel.
- Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
- Interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Bachelor's Degree in Engineering, Pharmacy, Chemistry or related scientific discipline, RN required, Life Sciences preferred, Masters preferred.
- 10+ years of experience in clinical research in the pharmaceutical industry or clinical research organization; experience in more than one therapeutic area is required; minimum of 8+ years of experience in Clinical Trial Operations management.
- Practical experience in clinical trial strategies, methods and processes, with deep knowledge of clinical trial design
- Analytical skills, quick perception and excellent judgment; able to identify risks and problems, to develop adequate problem-solving strategies even in complex situations, and to take appropriate measures when required.
- Computer skills required: Microsoft Office Suite; Project Management Software
- Domestic travel is estimated to be up to 25% for this position.
- 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.
- 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 five consecutive years based on our positive, values-based company culture
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Director, Clinical Operations - Plymouth Meeting, United States - Harmony Biosciences LLC
Description
Harmony Biosciences is recruiting for a Director, Clinical Operations in our Plymouth Meeting, PA location. In this role you will be accountable for providing leadership, technical delivery and oversight towards the successful execution of clinical study/program initiatives.
Responsibilities include but are not limited to:
Supervisory responsibilities:
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
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.
