Central Monitor

Job Title: Central Monitor

Location: Gurugram, India

Reports to: Associate Director, Clinical Trial Management

Help IAVI translate science into global health impact as a Central Monitor!

IAVI is seeking a Central Monitor in India, who will be responsible for leading and supporting centralized monitoring and risk-based monitoring activities for IAVI-sponsored clinical trials. This role will closely work with the global Clinical Trial Managers (CTMs) and cross-functional study team members to support ongoing, data-driven oversight of study and site risks.

Key Responsibilities:

• Lead risk-based and central monitoring activities for assigned IAVI-sponsored clinical trials in accordance with the Monitoring Plan, Risk Management Plan and other study-specific plans. This may include but not limited to:
• Conduct ongoing review and analysis of clinical trial data listings as defined in the Monitoring Plan to identify missing or inconsistent data, data outliers, unusual trends or distributions, potential protocol deviations, data quality concerns, safety signals and site performance issues.
• Track the status of site KRIs and other risk indicators defined in the Risk Management Plan and assess changes or trends over time.
• Integrate findings from KRI review, data-listing analysis and other relevant study information to assess site and overall study risk.
• Coordinate and lead central monitoring review meetings as per frequency defined in the Monitoring Plan.
• Prepare and maintain Central Monitoring Reports documenting the results of central monitoring activities, identified risks, trends, findings and recommended actions.
• Work with the Clinical Trial Manager and relevant functional teams to investigate identified issues, understand potential root causes and determine appropriate and actionable follow-up.
• Escalate potential concerns and other significant or critical findings to the appropriate study team members, where appropriate.
• Lead or support identification of appropriate risk mitigation actions, including recommendations for targeted site follow-up or changes to monitoring approaches, as appropriate.
• Support the study team during study planning and start-up in identifying Critical-to-Quality factors, key risks, acceptable ranges and KRIs, as appropriate.
• Provide input into the central monitoring approach and relevant sections of the Monitoring Plan and Risk Management Plan.
• Provide central monitoring insights and study risk updates to the clinical operations and broader study team, as relevant.
• Contribute to review of study status, site performance and other operational metrics as appropriate.
• Support preparation of study updates, presentations and other materials related to clinical operations and risk management.
• Participate in Clinical Operations departmental activities, including refinement/review of tools, templates and processes for central monitoring and risk-based quality management.

Education and Work Experience:

• Bachelor's degree in a scientific or related field is required.
• Minimum 5 years of clinical trials experience including clinical monitoring is required, preferably including clinical monitoring, clinical trial management, clinical data management or other relevant clinical research experience.
• Experience with centralized monitoring and/or risk-based quality management (RBQM) is strongly preferred.
• Experience supporting multinational or global clinical trials, preferably in sponsor, CRO, or public health settings, is desirable.

Qualifications and Skills:

• Excellent knowledge of ICH GCP as well as the Declaration of Helsinki and relevant country specific regulations are required.
• Good understanding of Risk-Based Quality Management principles.
• Interpersonal skills and ability to work effectively in a cooperative and collaborative manner with all levels, and across functional teams is required.
• Strong analytical and critical-thinking skills and ability to interpret clinical and operational data from multiple sources.
• Ability to work on problems of moderate complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action is required.
• Excellent oral and written communication skills are required.
• Ability to work independently and exercise sound judgment in identifying and escalating risks.
• A professional demeanor, as well as a pleasant manner and positive can-do attitude.
• Flexible and adaptable to accommodate changing deadlines to meet organizational needs is required.
• Excellent computer skills and proficiency in Microsoft Word and Excel is required.
• Experience with centralized monitoring platforms, dashboards or data visualization tools such as Power BI or equivalent would be a plus.
• High level of independence in performing responsibilities is highly desirable.
• Familiarity with HIV, TB, emerging infectious diseases
• Ability and willingness to collaborate effectively across time zones and geographic locations is required.

Organizational Overview:

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.

IAVI CORE VALUES:

• Commitment: We deliver on our mission, proactively transforming promises into tangible results
• Stewardship: We steward IAVI's resources responsibly to ensure IAVI's long-term success and global health impact
• Integrity: We uphold strong moral principles to maintain our credibility as a nonprofit scientific research organization
• Collaboration: We work as one IAVI team and partner with others to deliver globally accessible, urgently needed, public health solutions

Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an at-will relationship. IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

IAVI is an equal opportunity employer. It is IAVI's policy to provide equal opportunity without regard to race, citizenship, color, sex, gender identity or expression, age, height, weight, disability (including physical and mental conditions unrelated to job performance), religion, creed, caste, home language, ancestry, national origin, pregnancy, marital or partnership status, sexual orientation, status as a protected veteran, ethnicity, genetic information, predisposing genetic characteristic, status as a victim of domestic violence, stalking and sex offenses, HIV status, or any other status protected by applicable federal, state, or local laws.

Compensation And Benefits Information:

Salary is paid in local currency, and is commensurate and competitive with the local labor market. Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits including: generous retirement savings plan employer contributions; competitive health, dental and vision insurance plans; competitive paid time off policy; potential for annual bonuses based on performance; and other benefits. More information can be found on IAVI's career page.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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