Archived listing. The details below describe a past opening.
• As an organization whose mission is to translate science into global public health impact , working on vaccines and therapeutics, IAVI has a vaccine policy which states that subject to applicable law, we require all U.S. and Puerto Rico based employees to be vaccinated for COVID-19, unless they have an approved medical or religious exemption or accommodation. We are committed to supporting our employees during this process as we work to ensure a safe and healthy work environment.
Job Title: Senior Manager, Data Management Location: US Reports to: Senior Director, Biostatistics and Data Management, Clinical Development
Position Summary:
IAVI is seeking a highly qualified Senior Manager, Data Management (DM) who will oversee Contract Research Organization (CRO) vendors for IAVI's data management activities in support of Phase I - Phase IV clinical trials. This position will sit within the Clinical Development (CD) department and will be responsible for providing guidance to the CD team regarding the most appropriate data management tools (e.g., eDiary, ePRO), electronic data capture (eDC) systems, and vendors for IAVI’s clinical trials. In addition, the successful candidate will be responsible for managing timelines relating to key milestones and ensuring outsourced work has been performed with high quality.
Key Responsibilities:
- Provide oversight of outsourced DM activities, coordination with other functional areas, and management of overall timelines, resources and quality.
- Oversee DM-related responsibilities, including protocol development, trial start-up, database training, case report form (CRF) development, database build, edit checks, query resolution, data transfers, database lock, and all associated documentation for electronic trial master file (eTMF) filing.
- Act as a liaison between data management CROs and the CD team, in particular Clinical Operations and Biostatistics, by providing guidance on data management tools, such as eCOA/ePRO and eDiary, resourcing, timelines, metrics, CRF design, and database development support across clinical trials.
- Maintain DM-related eTMF materials for all IAVI clinical trials.
- Ensure CDISC/CDASH standards are applied by DM vendors and maintain global CRF library appropriate for all IAVI clinical trials.
- Oversee data management workflow of IAVI-contracted CROs to maximize efficiency across all clinical trial DM-related deliverables.
- Develop and review external (third party) data transfer agreements; consult with CROs to integrate external data into clinical databases.
- Review SDTM and ADaM dataset specifications to ensure conformity to Clinical Data Interchange Standards Consortium (CDISC) implementation guidelines and standards, as well as SDTM and ADaM datasets prepared by CROs to ensure consistency with dataset specifications.
- Provide/facilitate support as needed (technical, clinical) to ensure efficient action, collaboration and resolution of issues relating to data management.
- Assist QA team in performing vendor audits, as required.
- Write and revise relevant departmental Standard Operating Procedures (SOPs).
- Ensure compliance with departmental SOPs.
Education and Work Experience:
- BA or BS degree in Computer Science, Statistics, or related field is required.
- Minimum 7 years of experience in the pharmaceutical industry (biotech, pharmaceutical company, CRO) in a clinical data manager position is required.
Qualifications and Skills:
- Experience with various eDC platforms (e.g., Medidata Rave, IBM eClinical), along with tools such as eCOA/ePRO, eDiary, and IWRS as applied to clinical trials is required.
- Proven ability to be innovative, set realistic timelines, and provide leadership as part of a clinical study project team is required.
- Proven ability to implement GCP guidelines is required.
- Flexibility to change priorities and be comfortable with the changing deadlines to meet organization needs is required.
- Attention to detail, with the ability to work on multiple projects with overlapping schedules and priorities is required.
- Ability to work independently, as well as in a team while exercising discretion, is required.
- Solid knowledge of EMA and ICH regulations, CDISC, and FDA guidance are required.
- Proven track record of reviewing and understanding study protocols and other clinical related materials is required.
- Takes initiative to resolve problems is required.
- Solid knowledge of WHODrug and MedDRA coding dictionaries is required.
- Knowledge of current technological developments/trends in data management, database construction, management, and retrieval methods is required.
- Excellent verbal and written communications skills are required.
- Excellent computer literacy skills with expertise in Microsoft Office are required.
- Experience with preparing data for regulatory submission is desirable.
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:
- Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
- Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
- Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect
- Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference
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 actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. At IAVI, we celebrate the spectrum of colleagues’ experiences and believe that dedication to our mission above all is essential to our success as a scientific global non-profit. IAVI upholds these principles through IAVI’s Global Diversity and Inclusion Committee.
IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide.