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The Senior Associate, Central Monitor is responsible for ensuring the completeness, quality, and integrity of the subject data in the clinical trial database under Risk Based Monitoring (RBM) mode. The areas of activity include but are not limited to: developing Risk-Based Monitoring system for applicable studies, ensuring key risk indicators (KRIs) properly defined and set up in the system to support the study, processing and reviewing study data in the system for the signal and action management, follow up for the issue resolution. The Senior Associate, Central Monitor ensures risk-based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs) and Processes at all times and is familiar with supported systems (RBM system, etc.) and able to troubleshoot and provide rapid response for all database issues. The Senior Associate, Central Monitor ensures quality oversight/control steps implemented in the central monitor activities. The Senior Associate, Central Monitor works with the global study team to meet the study objectives.
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Must-Have:
• Bachelor’s degree or above or equivalent experience in a scientific or business-related discipline required.
• 2-4 years working experience in the clinical development fields.
• Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design.
• Previous experience within a data management role, understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, DMPs and data cleaning activities.
• Knowledge of clinical trial database and its applications.
• Works independently, receives instruction primarily on unusual situations.
• Ability to organize tasks, time and priorities; ability to multi-task.
• Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally.
• Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.).
• Technical expertise and business experience in supporting clinical trials database development, data management, site monitoring, etc.
• Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
• Project management skills and technical capabilities as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• Good understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.
Nice-to-Have:
• Master's degree.
• Relevant pharmaceutical industry experience.
• Experience in Oracle, PL/SQL, SAS, R/R-Shiny, Python, Java, relational database design and database programming skills.
• Experience using data visualization tools.
• Proficient experience using commercial clinical data management systems and/or EDC products.
• Awareness of regulatory requirements and relevant data standards.
• Knowledge of basic statistical principles and statistical methodology.
• Routine problem-solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situations.
• Experience in developing successful partnerships within study teams.
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here! |
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