Clinical Operations Manager – Study Initiation
The position is accountable for management of US clinical site deployment across the US Vaccines portfolio of clinical studies. The position is also accountable for oversight of third parties involved in study start-up activities related to validation of clinical site cold storage units, management of ancillary clinical study supplies, and management of metric reports. The position has responsibility for line management of internal staff and oversight of vendor staff.
CLINICAL INVESTIGATOR RESOURCE POOL MANAGEMENT
• Coordinate clinical investigator deployment across the portfolio to ensure clinical site availability is not rate-limiting to clinical development plans within country across projects
• Curate historical performance information of GSK investigators and identify potential investigators without GSK Vaccine history to ensure that the potential US investigator pool is understood and can be strategically managed across the portfolio
• Identify new investigators to address new therapeutic areas and to increase the number of potential investigators in high-demand areas and in under-represented populations
• Support clinical development planning and country feasibility assessments at both study and portfolio level by providing projected subject recruitment timings and other input
• Ensure delivery of adequate numbers of potential sites to be considered for each study based on strategic site allocation considerations across the portfolio
• Line manage internal staff responsible for site feasibility and selection activities
• Coordinate oversight of external (non-GSK) vendor managing support services to the site selection team (CDAs and state sanction support, etc.)
CLINICAL SITE COLD STORAGE UNIT ASSESSMENT AND ANCILLARY SUPPLY MANAGEMENT
• You would be accountable for oversight of external (non-GSK) vendor managing:
-clinical site cold storage unit (refrigerators & freezers) validation process (includes initial assessments and periodic re-validation)
-the identification, ordering and distribution of clinical study ancillary supplies
-the coordination of recruitment and retention materials for study teams
METRIC REPORT OVERSIGHT
• You would be accountable for the oversight of metric report data delivered by an external vendor, including
-Development of new report requests and detailed instructions
-Participation in vendor management and task order review and update
• BS plus 7 years OR MS plus 5 years of relevant experience in the Pharmaceutical, Biotech or Healthcare Industry with an emphasis on drug development and project management, ideally in a multidisciplinary environment
• Superior interpersonal skills and expert team player with demonstrated ability to build collaborative relationships at all levels inside and outside of the organization, specifically with line management staff and with management at all levels in partner vendor organizations
• Solid knowledge of drug development process; preferably of vaccines development
• Solid understanding of the US Healthcare System and investigator sites
• Superior analytical skills and ability to think / frame problems strategically
• Well-organized, excellent time management with respect to priorities and self-management
• Able to work in ambiguous circumstances and take actions quickly while involving the right team members in the right situation at the right time
• Ability to understand and maximize utilization of databases for investigator/site identification
• Line management experience preferred
GSK has a 150-year legacy of helping to transform the health, lives and futures of millions of people around the world. We're a science-led healthcare company with more than 100,000 people working in 115 countries. Each year we produce around 4 billion packs of medicine, nearly 900 million doses of vaccine and more than 18 billion packs of consumer healthcare products. Our focus of helping people do more, feel better and live longer is at the center of all that we aim to do.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries. The vaccines in our portfolio have been helping to protect people from serious disease for well over 100 years, with our Marietta (US) site dedicated to smallpox vaccine production since 1882. Today, our vaccines continue to tackle some of the world's most devastating diseases, including pneumococcal disease, meningitis, hepatitis, rotavirus, whooping cough and influenza. Our Vaccines business has a portfolio of more than 40 vaccines for every stage of life, helping to protect people against 22 diseases. We have a pipeline of 14 candidate vaccines in development. One third of our vaccines in development target diseases particularly prevalent in the developing world, including all three WHO infectious disease priorities: HIV, malaria and TB. Our other vaccines in development include vaccines for the treatment of COPD and prevention of Respiratory Syncytial Virus (RSV). In October 2017, our shingles vaccine, Shingrix, received regulatory approval in Canada and the US.
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