Title:               Associate Director, Global Monitoring Operations

Reports to:      Sr. Director, Global Monitoring Operations

Location:         Remote-based (US)

 Position Overview:

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.

 Responsibilities:

·      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.

·      Lead or participate in interviewing, hiring, onboarding, and orientation processes for Company CRAs.  Review proposed CRO CRA staff against established qualifications and document outcome.

·      Support CRAs, project team, and Quality Assurance with responses to audits or inspections.

·      Represent Monitoring Operations in cross-functional meetings and initiatives as a subject matter expert.

 Requirements:

Education and/or Experience

·      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.

 Competencies and Attributes

·      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.

·      Excellent verbal and written communication skills with the ability to work collaboratively with cross-functional teams.

·      Excellent organizational and negotiation skills, along with strong attention to detail and time management proficiency.

·      Maintains literacy in Microsoft tools and clinical study software applications.

·      Ability to travel domestically approximately 20%.