Company Introduction
Our client leads the pharmaceutical world markets by providing high-quality healthcare systems for a variety of customers in the United States. Their extensive experience enabled them to build long-lasting partnerships with major companies around the world while adapting their services to the needs of their clients. Since their foundation, innovation has been a driving force for the company thanks to their teamâs ability to always find and exploit innovative ideas.
Role
Job Overview: You will be a key member of the pharmaceutical data department, working with a team to ensure that the companyâs services meet quality standards in the United States. You will also help monitor and regulate the efficiency of the departmentâs services, ensuring an optimal pace for all core and ad-hoc activities.
You will also be expected to work with other departments to meet research project requirements; Deal with information discrepancies, update research registries, procedures, and tools as well as provide reports about the progress of each project.
Responsibilities and Duties:
⢠Develop and maintain data management documentation, including study protocols, case report forms, and data management plans.
⢠Design case report forms (CRFs) and electronic data capture (EDC) systems for data collection.
⢠Perform data entry and cleaning activities, including discrepancy management and query resolution.
⢠Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
⢠Develop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, validation check testing, and approval.
Profile Requirements
⢠Fluency in English is a must; previous professional anglophone experience is a plus.
⢠At least a bachelor's degree in pharmaceutics or any relevant discipline is necessary.
⢠At least 5 years of work experience as a clinical data manager or a similar role.
⢠Strong understanding of clinical trial processes, data management principles, and regulatory guidelines.
⢠Proficiency in electronic data capture (EDC) systems and clinical data management software.
⢠Familiarity with relevant regulations and guidelines, like GCP and CDISC standards.
Your email job alert is now active!