Responsibilities
- Lead the creation and documentation of Central Monitoring Plans for clinical programs.
- Contribute to the development and maintenance of the Quality Risk and Control Tracker (QRACT).
- Deliver presentations during CRO initiation meetings.
- Collaborate with data analysts on technical setup, deployment, and operation of Risk-Based Quality Management systems for central monitoring across trials.
- Perform and communicate central monitoring reviews at both study and program levels using analytical tools.
- Analyze relationships between key performance indicators and supporting data to evaluate trends at site and study levels.
- Evaluate, interpret, and report data as a core member of the Clinical Study Team to identify monitoring needs and sites requiring sponsor action.
- Assist study teams in assessing the significance, root causes, and implications of findings, and help determine corrective actions.
- Record outcomes from central monitoring review meetings and follow through on action items to resolution.
- Utilize and update relevant tracking and reporting systems such as CTMS and ODR as needed.
- Develop strategies, interpret data, and deliver insights for central monitoring under the RBQM framework at functional and collaborative levels.
- Present updates at regular quality risk review meetings at study and program levels with subject matter experts.
- Serve as a subject matter expert on central monitoring implementation within study teams.
- Support audit and inspection readiness and execution related to central monitoring activities when required.
- Collaborate with outsourcing management and CRO counterparts to align on monitoring strategies, standards, and documentation.
- Oversee CRO partners’ central monitoring activities to ensure adherence to the Partnership Operations Manual.
- Critically assess the availability, quality, and utility of integrated data, metrics, and reports supporting central monitoring processes.
- Participate in process improvement efforts and functional strategic planning initiatives.
- Evaluate and refine the central monitoring process, including detection method sensitivity and integration of new technologies.
- Delegate tasks and assign work to Central Monitoring Associate Managers and Central Monitoring Managers.
- Manage direct reports through performance goal setting, ongoing feedback, coaching, development planning, and administrative tracking.
Requirements
- Demonstrated experience with CluePoint or comparable Risk-Based Quality Management systems for central monitoring.
- Strong problem-solving, troubleshooting, and resourcefulness skills.
- Proven background in analytical problem solving.
- Familiarity with clinical drug development, ICH, and GCP guidelines and regulatory requirements.
- Effective communication and interpersonal abilities with capacity to build internal and external relationships.
- Awareness of current and emerging business trends and industry developments.
- Strong writing skills to convey information clearly and effectively.
- Proficiency in Microsoft Office applications.
- Bachelor’s degree or higher.
- Minimum of 8 years of relevant experience in biotechnology or pharmaceuticals.
- At least 3 years of direct experience in central monitoring.
Nice to Have
- Prior experience in site monitoring or data management is advantageous.
Benefits
- Comprehensive health and wellness benefits including medical, dental, vision, life, and disability insurance.
- Access to fitness centers.
- 401(k) plan with company matching.
- Family support benefits.
- Equity awards.
- Annual performance bonuses.
- Paid time off.
- Paid leaves for military and parental responsibilities for eligible employees.
Compensation
Salary ranges apply for U.S.-based roles; for Japan and Canada, ranges are provided in local currency per applicable law; other regions should consult with recruiter.
Work Arrangement
On-site
Team
Integrated within the Clinical Study team; collaborates closely with Central Monitors, data analysts, CRO partners, and other study team members.
Other
- Up to 25% travel may be required.
- Background checks are part of the hiring process.
- Verification of identity, work authorization, and educational credentials will be conducted.
- The organization is an equal opportunity employer.
- Reasonable accommodations are provided for qualified applicants with known disabilities or chronic conditions, unless doing so would cause undue hardship.
- Salary ranges apply for U.S.-based positions.
- For roles in Japan and Canada, salary ranges are disclosed in accordance with local laws and currencies.
- For other countries, applicants should discuss compensation and benefits with the recruiter.
Not specified
