Senior Manager, Clinical Research Operations

Harmony Biosciences is recruiting for a Senior Manager, Clinical Research Operations in our Plymouth Meeting, PA location. In this role you are responsible for supporting Sponsor oversight of study integrity at sites participating in Sponsored clinical trials, Phase 1 through Phase 3. This involves supporting the Clinical Operations team with the management of CROs, vendors and clinical sites to ensure study timelines and study objectives are met, experience in early phase studies is a plus. The Senior Manager will also provide support in ensuring investigative sites are inspection ready and conduct pre-inspection readiness visits with Harmony investigative sites

Responsibilities include but are not limited to:

• Provide clinical study start up expertise in the planning and initiation of global clinical trials.
• Assist with the preparation of IRB submissions including the review of the site-specific informed consent and assent forms
• Assist and/or participate in planning and conduct of Investigator Meetings as necessary.
• Review the performance of the trial at designated sites.
• Ensure the rights and well-being of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Ensure the quality and integrity of the reported data on case report forms (CRFs) by careful and thorough source documentation review and source document verification. Generate queries and assist sites with resolution.
• Track and follow serious adverse events (SAEs) ensuring timely reporting to appropriate entities.
• Supports TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents.
• Reviews the completeness and quality of the investigator site file (ISF). Collects and reviews essential documents.
• Prepare accurate and timely trip reports while documenting visit findings.
• Assists in resolving any issues to ensure compliance. Escalating issues to Director / Manager, as necessary.
• Maintain regular communication with sites.
• Conduct all aspects of site monitoring of clinical research studies according to Standard Operating Procedures, ICH Guidelines and GCP.
• Performs other related duties as assigned by management
• Track patient enrollment and identify recruitment and retention issues
• May oversee the CRO's site monitor and/or co-monitor at SIVs, SMVs, and COVs.
• Develop or review the Clinical Monitoring Plan, monitoring tools, annotated trip reports, and CRA training material

Qualifications:

• Bachelor's Degree within a scientific discipline required
• 4+ years' experience in clinical research monitoring (CRO or sponsor) required; Therapeutic experience in neurology preferred but not required
• Familiarity with scientific methods, research design, and clinical trials
• Proficient in the use of Microsoft Office Suite; use of Clinical Trial Management and Electronic Data Capture Systems

Physical demands and work environment:

• Domestic travel throughout the US is estimated to be 25% of the time for this position.
• While performing the duties of this job, the noise level in the work environment is usually quiet.
• The employee must occasionally lift and /or move more than 20 pounds.
• 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 seven 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 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.

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