Senior Manager, Clinical Research Operations

Role Summary

Senior Manager, Clinical Research Operations responsible for supporting sponsor oversight of study integrity at sites participating in sponsored clinical trials (Phase 1–3). Supports the Clinical Operations team with management of CROs, vendors, and clinical sites to meet study timelines and objectives; experience in early phase studies is a plus. Provides support to ensure investigative sites are inspection ready and conducts pre-inspection readiness visits with Harmony investigative sites.

Responsibilities

• 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 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 applicable regulatory requirements.
• Ensure the quality and integrity of the reported data on case report forms (CRFs) by 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.
• Support TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents.
• Review the completeness and quality of the investigator site file (ISF); collect and review essential documents.
• Prepare accurate and timely trip reports while documenting visit findings.
• Assist in resolving issues to ensure compliance; escalate issues to Director/Manager as necessary.
• Maintain regular communication with sites.
• Conduct all aspects of site monitoring of clinical research studies according to SOPs, ICH Guidelines, and GCP.
• Perform 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.
• 6+ years‚Äô 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; experience with Clinical Trial Management and Electronic Data Capture Systems.

Physical Demands

• Domestic travel throughout the US estimated at 25% of the time.
• Work environment is typically quiet.
• Occasional lifting and/or moving more than 20 pounds.
• Specific vision abilities required: close vision.
• Manual dexterity to use computers, tablets, and cell phones.
• Continuous sitting for prolonged periods.