9 Manager, Clinical Operations Jobs in Plymouth Meeting, PA
Harmony Biosciences, LLC is Hiring a Manager, Clinical Operations Near Plymouth Meeting, PA
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.
- Bachelor’s degree required; Masters degree is preferred.
- 4 years of experience 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
- 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.
- 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
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.
Job Summary
Full Time
Pharmaceutical
$147k-202k (estimate)
05/18/2024
07/15/2024
harmonybiosciences.com
PLYMOUTH MEETING, PA
100 - 200
2017
Public
JOHN JACOBS
$5M - $10M
Pharmaceutical
Related Companies
About Harmony Biosciences, LLC
Harmony Biosciences is a biopharmaceutical company that researches and develops novel therapeutics for patients with orphan and rare diseases.
The job skills required for Manager, Clinical Operations include Clinical Operations, Initiative, Clinical Trial, Clinical Research, etc. Having related job skills and expertise will give you an advantage when applying to be a Manager, Clinical Operations. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Manager, Clinical Operations. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Manager, Clinical Operations positions, which can be used as a reference in future career path planning. As a Manager, Clinical Operations, it can be promoted into senior positions as a Critical Care Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Manager, Clinical Operations. You can explore the career advancement for a Manager, Clinical Operations below and select your interested title to get hiring information.
Similar Jobs
Popular Articles
