Regional Clinical Trial Manager (Unblinded Lead and Start-up Specialist)

Job Title: Regional Clinical Trial Manager – (Unblinded Lead and Start-up Specialist)

Location: Gurugram, India

Reports to: Associate Director, Clinical Trial Management

Help IAVI translate science into global health impact as a Regional Clinical Trial Manager!

IAVI is seeking a Regional CTM, India, who will be responsible for the day-to-day operational activities enabling the conduct of clinical trials according to ICH/GCP guidelines. The role will work closely with the Global CTMs, cross-functional study teams, clinical research sites and CROs to support unblinded activities, study start-up and other operational coordination where applicable.

Key Responsibilities:

Unblinded CTM:

Serve as the unblinded lead for assigned blinded studies ensuring appropriate handling and documentation of unblinded information and maintaining the integrity of the study blind. The responsibilities may include but not be limited to:

• Reviewing unblinded monitoring visit reports (MVRs) and working with the CRA to finalize reports within the deadline set in the study Monitoring Plan
• Cross-checking information in the unblinded MVR with the randomization list for each study
• Leading or supporting investigations into deviations that involve unblinded data
• Filing unblinded documents in the TMF and performing reconciliations of unblinded documents in each study TMF as required by the Document Management Plan
• Reviewing laboratory test results or other study information that may be unblinding
• As required, liaising with the IAVI Manufacturing and clinical research sites to enable adequate and timely IP supplies at sites

Study Start-up:

• Perform study start-up activities as assigned by the Clinical Trial Manager or Director, Clinical Operations. These may include but not be limited to:
• Coordinating site feasibility questionnaires and collating responses
• Liaising with selected sites to collect required documents for regulatory and ethics submissions
• Review site-specific informed consent documents to ensure all essential elements are included and study-specific information is accurately covered as per the Master Informed Consent Document
• Reviewing site SOPs to ensure they adequately cover GCP requirements and are fit for purpose for the trial
• Reviewing site source documents and tools to be used in the study
• Coordinating and supporting identification and resolution of site start-up issues. Escalate any risks and document decisions.
• Developing and maintaining study start-up trackers and site-activation timelines
• Maintaining oversight of assigned study start-up documentation and ensuring timely filing in the Trial Master File (TMF)
• Contribute to internal IAVI study plans (e.g., Monitoring Plan, Risk Management Plan)
• Assist CTM in establishing study timelines for clinical aspects of trials
• Provide study status updates to project team and management as needed.

Other duties:

• May be assigned one or more sites to monitor (either blinded or unblinded)
• May participate in Clinical Operations departmental activities as assigned, including drafting or reviewing operational procedures, tools and templates
• Participate in departmental and cross-functional meetings as appropriate
• Share relevant operational knowledge and lessons learned across Clinical Operations team

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.
• Clinical team lead experience is preferred.
• Experience supporting multinational or global clinical trials, preferably in sponsor, CRO, or public health settings, is highly desirable.

Qualifications and Skills:

• Excellent knowledge of ICH GCP and FDA CFR guidelines as well as the Declaration of Helsinki and relevant country specific regulations are required.
• Interpersonal skills and ability to work effectively in a cooperative and collaborative manner with all levels, and across functional teams both internally and externally is required.
• 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 project planning, organization and implementation skills in a cross-disciplinary and multi-cultural environment.
• Excellent oral and written communication skills are required.
• Proven ability to coordinate and lead multi-disciplinary project teams is required.
• Ability to manage multiple priorities while working independently in a global, matrixed environment.
• 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.
• Experience working with electronic TMFs and Clinical Trial Management Systems is required.
• Excellent computer skills and proficiency in Microsoft Word and Excel is required.
• 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.
• Ability to travel internationally as required for study activities.

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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