At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ‘Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. Clinical Data Manager Position Purpose: The Clinical Data Manager (CDM) leads and/or supports the execution of data management activities necessary for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community. The CDM may assume the business role of a Study Data Manager in studies with standard complexity. In this capacity, s/he serves as the primary contact for Data Management on the Core Study Team. The SDM leads the SDM team, which is comprised of several Extended Study Team members, to ensure data management deliverables meet, or exceed, corporate and industry quality standards in a timely and cost efficient manner. The CDM may support SDMs for complex trials to ensure completion of tasks in a timely manner at high quality. Scope: Global Major tasks and responsibilities: Serves as the subject matter expert on topics related to data management activities, including vendor selection and management, mentoring junior staff, training team members, and presenting best practices at internal and external industry meetings. Assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, applying Data Management best practices. Accountable or a contributor for CDM deliverables from protocol creation until release of data for analysis. Ensures CDM input and contributions to Risk Management. Incorporates and maintains Medical Standards in clinical studies for all elements of the medical standards package. Documents all activities adequately for all assigned studies according to SOPs and takes a lead role in QC activities. Specifies and develops study specific eCRFs, data consistency checks based on Medical Standards, and contributes to the database structure. Contributes to the preparation, tracking and implementation of standard plans to ensure proper governance of data management study set-up, conduct and closure activities. Accountable for or contributes to data management activities necessary for the establishment of subject validity and analysis set assignment. Engages actively in ongoing data review/reconciliation activities and utilizes dashboards, metrics and patient trackers to monitor data arrival and clean up. As applicable, plans and tracks data contributions of specialized functions typically used for early clinical development activities. Establishes data management best practices for data generated in relevant research activities. Operational Data Management Supports or drives study data management and data cleaning processes on an ongoing basis. Identifies and issues queries, incorporates query replies and tracks query status. Contributes to projects and initiatives aimed at improving the delivery of DMAR and CDM. Ensuring Compliance Performs duties in compliance with SOPs, GCP and ICH guidelines. Ensures complete, accurate and timely documentation for all projects/studies according to established SOPs. Value added: The Clinical Data Manager supports or is responsible for the consistency in support, planning and delivery of data management deliverables in assigned studies, projects, or research activities. Work Interactions: Represents CDM as the Core Study Team member for internal and outsourced studies. Contributes to cross-functional teams and interfaces effectively. Works closely with clinical and safety experts in the definition, preparation and review of reports. Establishes and tracks data management activities in cooperation with relevant departments. Develops robust and productive relationships with internal and external business partners. Qualifications & Experience: Bachelor’s degree (or equivalent/higher), preferably in a relevant field. At least 3 years of study level experience as a Data Manager. Good understanding of the drug development process. Strong organizational skills and able to collaborate with limited supervision. Broad experience in using data management methodologies and technologies. Demonstrated understanding of regulations and guidelines. Adheres to a high ethical standard. YOUR APPLICATION This is your opportunity to tackle the world’s biggest challenges with us. Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. Location: Division: Enabling Functions Reference Code: 836047 #J-18808-Ljbffr