Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Senior Clinical Data Manager

Your tasks and responsibilities

 DM Expertise
 - Serves as the key subject matter expert on topics related to data management activities including specific activities and processes in early clinical development phases. Contributions include, but are not limited to: vendor selection and management, mentoring junior staff, training team members, leading or contributing to expert working groups
 (e.g., QSD initiatives), presenting best practices at internal and external industry meetings meetings/congresses, and participating in due diligence assessments.
 
 PDM/EPDM tasks
 - Governs use of key data management elements across studies in assigned projects: assumes ownership of development and maintenance of Medical Standards relevant to the area of responsibility; contributes to the definition of data structure standards; review applied results of the Important Medical Event (IME) List and, medical coding conventions.
 
 - Ensures adequate application of Data ManagementBest Practices across studies within assigned projects: review Study Team documents for project consistency; ensure the adequate documentation of all data management activities according to SOPs.
 
 Incorporates and maintains Medical Standards in clinical studies and projects for all elements of the medical standards package.
 
 
 - Provides governance and oversight for outsourcing activities by providing input on budgetary items (e.g. RFP, vendor costing, synergies, change orders, etc.), vendor selection and management, risk and communication management, definition of deliverables, Bayer-internal QC measures, progress tracking, and application of best data management practices.
 
 - Advises on resource planning/allocation based on forecasted clinical activities per the Clinical Development Plan (CDP) and actual study/project metrics.
 
 - Ensures smooth phase-transitioning of projects between research and development phases within P&O.
 
 - Organizes state-of-the-art support for data-driven processes of interfacing business functions like Pharmacovigilance department, Pharmacokinetic department, Pharmacometrics department, and others by ensuring timely and high quality Data Management input.
 
 - Actively supports assessment of future trends to prepare for the future , including personalized medicine, evidence based re-imbursement, smart data storage, data insights, predictive and probabilistic data management methods, digital studies, wearable devices.
 
 SDM tasks
 - Assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and apply Data Management best practices
 
 - Accountable or a contributor for CDM deliverables from protocol creation until release of data for analysis.
 
 - Ensure CDM input and contributions to Risk Management (risk identification, risk communication, incorporation of risk in risk management plan, implementation of risk mitigation activities in relevant plans)
 
 - 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, which includes, but is not limited to: initiating the documentation, maintaining document management systems, coo

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Country: China
Location: BeiJing
Functional Area: [sap_fa_28]
Entry Level: 5