Website NJ Eye
A large multi-site, specialty/sub-specialty medical group with 16 clinical offices in central and northern New Jersey is seeking Manager, Clinical Trials to provide strategic and operational leadership for clinical research studies and manage all aspects of clinical trials that evaluate new medications and medical devices in compliance with GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs and protocols.
Role and Responsibilities:
- Plans, develops and implements clinical research trials involving the study of agents to treat diseases of the retina, macula and vitreous.
- Collaborates with internal/external stakeholders – Principal Investigator, patients, clinical staff, pharmaceutical sponsors, Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers
- Apprises operational leadership on overall clinical trial plans, updated forecasting, and of potential issues/mitigation regarding study plans
- Oversee contract management, quality, and budget. Review/approval of vendor invoices and management of accruals and Statement Of Work changes.
- Responsible for monitoring quality and adherence to established processes and plans
- Develops subject recruitment/retention strategy and related initiatives
- Ongoing quality review and final reconciliation of study documents
- Facilitates Serious Adverse Event (SAE) reporting process, manages sponsors and IRB interaction
- Ensures compliance with protocols, Good Clinical Trials Practices as well as perform all aspects of the study
- Creates internal audit plans and coordinates with external stakeholders and regulated bodies regarding audits
- Local travel to clinical offices required
- Responsible for special projects and other assignments as required
Education: Bachelor’s degree in Health Sciences, Public Health, Clinical Research, Science in Nursing and/or relevant field.
Experience: 6+ years of clinical trial/study management experience and knowledge. Managing study sponsors, CROs and vendor management experience highly preferred. Experience with clinical trials related to the diseases of the retina, macula and vitreous a plus.
- Experience with study start-up, timeline planning and management and financial management of clinical trials including vendor oversight
- In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
- Ability to effectively lead and direct a cross-functional team in a matrix environment
- Experience with data collection processes, data review and comfort with using technology including analytics
- Excellent organizational and time-management skills
- Ability to identify critical issues and escalation to leadership when appropriate. Demonstrated judgment, organizational, planning, and control skills
- Leadership / influence management skills including stakeholder management and effective communication
- Solid computer skills – requirement of MS applications – MS Project, Word, Excel, PowerPoint
- Study Tools including electronic system skills – CTMS / EDC/eTMF, etc. preferred
NJ Retina is an Equal Opportunity Employer
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