AD Monitoring

Remote AD Monitoring – Perm - $150,000 - $220,000
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Remote AD Monitoring

Role Description

The Associate Director (AD), Global Monitoring Operations is responsible for monitoring execution and quality oversight for insourced and CRO outsourced studies at company. The AD, Global Monitoring Operations will also be responsible for management of assigned company CRAs to optimize productivity and ensure quality, efficient end-to-end delivery of Monitoring Operations. The AD, Global Monitoring Operations will support the development of process and practices within the Monitoring Operations function.

• In collaboration with Clinical Trial Management, initiate a study monitoring strategy and oversight plan and ensure that the monitoring activities for each assigned study/region are compliant with the Clinical Monitoring Plan.
• Author or review Clinical Monitoring Plan.
• Participate in site feasibility, qualification, and selection.
• Conduct or arrange for monitoring oversight visits (MOV) for CRO, and CRA assessment visits for company CRAs to assess completeness and accuracy of site monitoring activities.
• Proactively identify issues at a study, site or CRA level, and ensure resolution of issues, identification of areas of risk and mitigation strategies.
• Document and track performance indicators and metrics for trends and to assess CRO and/or company CRA progress, quality, Clinical Monitoring Plan compliance and overall performance.
• Review Monitoring Visit Reports from CRO and/or company CRAs and escalate monitoring visit trends or findings to Clinical Operations study leads.
• Track status of reports, action items, and corrective/preventative actions identified for sites and/or monitoring performance.
• Training and support for the CRO and/or company CRA team on monitoring aspects of the study in partnership with other team members as needed.
• Act as a point of escalation for resolution of site performance, quality or compliance problems.
• Attend CRO oversight or extended study team meetings.
• Maintain strong relationship with CROs and investigator sites.
• Represent and provide input into evaluation of monitoring services in the CRO proposal process and offer recommendations for CRO selection.
• Lead or provide input into monitoring and/or other functional area processes and forms.
• May be responsible for direct management of assigned FTE CRAs, including routine performance feedback/assessment, resourcing, coaching, training, career development, and corrective action plans.
• Oversee Functional Service Provider (FSP) or Contract CRAs if used within company.

Skills & Requirements

• Bachelor’s degree in scientific or health care discipline required; master’s degree or higher is a plus.
• At least 8+ years’ experience, with at least 5 years as a CRA and 3+ years demonstrated management leadership.
• Experience monitoring and overseeing Phase 1-3 clinical trials; experience in first in human trials is a plus.
• Knowledge and demonstrated application of Good Clinical Practices, ICH Guidelines and regulatory requirements.
• Neuroscience, oncology, and/or rare disease therapeutic experience preferred.
• Demonstrated leadership to drive results that are needed to achieve company objectives in accord with company’s culture and values – courageous, imaginative, selfless and joyful.
• Demonstrates effective CRA leadership, supervisory and mentoring skills.
• Excellent monitoring and leadership experience in startup, execution and close out activities related to clinical studies, including onsite and remote monitoring; knowledge and experience using risk-based monitoring processes preferred.
• Excellent team player with team building skills and ability to develop strong relationships with internal and external colleagues.
• Superb interpersonal and conflict resolution skills.
• Ability to adapt quickly and effectively to change.
• Ability to demonstrate critical thinking, root cause analysis and problem solving to support CRO and/or company CRAs and study teams in identifying site process failures and to develop corrective and preventative actions to bring sites into compliance.
• Proactively identifies and mitigates risk.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

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Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information. #1143005

Summary

Job Type
Permanent
Industry
Technology & Internet Services
Location
Remote
Specialism
Infrastructure
Pay
150,000 - 220,000
Ref:
1143005