Senior Manager, Field Monitoring

Description

(Local Candidates Preferred; Open to Candidates Outside of California)

Job Title: Senior Manager, Field Monitoring

Supervisor/Manager Title: Director, Clinical Affairs

Job Description Summary: The Senior Manager, Field Monitoring is responsible for the management and oversight of global monitoring activities across the trials in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs. He or she will work closely with the Study Managers, in-house CRAs, Data Management, Safety, vendors/CROs, and other functions to support or lead all or monitoring aspects of study start-up, site activation, enrollment, database lock, close-out, and other key study activities. Serves as primary communications liaison for clinical monitoring and study teams, identifying, resolving, and escalating any issues, as appropriate.

Job Responsibilities:

• Provide leadership and oversight of the strategic planning of clinical trials, such as aligning monitoring activities with broader study objectives, and providing input on trial design to optimize monitoring efficiency and effectiveness.
• Document and share insights into trial monitoring activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, etc.
• Highlight experience with or responsibilities for implementing risk-based monitoring approaches, including the use of data analytics tools.
• Assist with resolving, identifying of study risks including background and actions to prevent reoccurrences
• Verify trial data, collect case report forms, maintain appropriate regulatory documents both internal and external, audit sites to ensure they have appropriate regulatory documentation to conduct the trial, and source documentation is properly recorded
• Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues
• Oversee monitoring team comprised of internal and external resources
• Provide direct support to the Study Manager with monitoring visit report review and other managerial tasks as needed
• Supporting site enrollment progress including device accountability and protocol deviations
• Ensure device accountability, device complaints and malfunctions, adverse events, and protocol deviations are reported in a timely manner in accordance with regulatory and internal requirements
• Provide support for study sites, and CRAs with audits/inspections preparation/responses and quality issues, as needed, and follow-through with audit/inspection findings to resolution as it related to involved CRA staff
• Assist with other assigned clinical responsibilities within scope of role to provide best practice and/or support to junior clinical staff
• Develop and deliver training on GCP(s), protocols, database, ethics and compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities
• Contribute to the development of clinical protocols, informed consent forms, and case report forms, clinical monitoring plan and other study documents
• Identify continuous improvement initiatives, such as refining monitoring processes based on lessons learned from previous trials
• Travel up to 30% and/or as needed

Qualifications

Required Education and Experience:

• 7 years of experience in field monitoring, quality assurance/control and regulatory compliance required
• Advanced degree in a biological science / pharmacy/ nursing desired.
• Proven experience in managing or monitoring global clinical trials
• Track record of executing study start-up, site activation, enrollment, database locks, and close-out
• Line management/direct report and vendor management experience

Skills and Abilities Required for This Job:

• Experience working in a medical device or similar regulated industry
• Experience with electronic data capture, electronic trial master file, and other clinical trial management systems
• Experience in change management; particularly in adapting to new regulations, technologies, or methodologies within the team
• Proficiency with MS Office Suite
• Experience in interventional cardiology or cardiothoracic surgery preferred
• Ability to work collaboratively as part of a multi-functional medical device development team in a dynamic environment
• Must be self-motivated, highly organized, detail-oriented and able to multi-task, delivering high quality work
• Demonstrated ability in oral and written communication skills; excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally
• Ability to work in a fast-paced work environment within a cross-functional and highly interdependent team structure

Salary : $140,000 - $165,000