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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.
Principal Clinical Data Manager
Your tasks and responsibilities
The primary responsibilities of this role,Principal Clinical Data Manager, are to:
+ Assume ownership and leadership for all Clinical Data Management owned deliverable within assigned compound, projects and studies and provide leadership to respective CDM staff, interfacing functions and teams in order to support and achieve defined business goals;
+ DM Expertise - Serve as the key subject matter expert on topics related to data management activities including specific activities and processes in early clinical development phases;
+ Contribution 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 practice at internal and external industry meeting/congress, and participating in due diligence assessment.
+ PDM/EPDM tasks - Govern use of key data management element across studies in assigned projects;
+ Assume ownership of development and maintenance Medical Standard relevant to the area of responsibility;
+ Contribute to data structure standards;
+ Review result of applied Important Medical Event (IME) List, medical coding conventions;
+ Accountable or a contributor for CDM deliverables on study and/or project level;
+ Ensure adequate application of Data Management Best Practices across studies within assigned projects;
+ Review Study Team documents for project consistency and ensure the adequate documentation of all data management activities according to SOP;
+ Provide 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 practice;
+ Advise on resource planning/allocation based on forecasted activities per the Clinical Development Plan (CDP);
+ Key Task - Study/project metrics;
+ Ensure CDM input and contribution to Risk Management (risk identification, risk communication, incorporation of risk in risk management plan, implementation of risk mitigation activities in relevant plans);
+ Proactive DM specific project planning and tracking (timelines, budget, risk assessment) of assigned project from D3 to PoC and/or to submission, fully aligned with the Statistics function (2-Lead model) and the corresponding activities of the Early Clinical Team and Clinical Project Team;
+ Ensure smooth phase transitioning of project between research and development phases in P&O, is instrumental to facilitate data access and exchange between research and development functions;
+ Organize 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;
+ Establish data management best practice for data generated in research activities;
+ Actively support assessment of future trend 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;
+ Engage actively in ongoing data review/reconciliation activities and utilizes dashboards, metrics and patient trackers to monitor data arrival and clean up;
+ Share data arrival and cleanup status and metrics with the Study Team while Implementing Strategy;
+ Support the development and implementation of DMAR and/or OSBU DM strategic initiatives and activities;
+ Contribute to project and initiative aimed at improving and optimizing the delivery of DMAR. DS&A, Portfolio & Operations, OSBU ensuring Compliance;
+ Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards;
+ Ensure complete, accurate and timely documentation for all projects/studies according to established SOPs.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
+ The incumbent possess high skill and knowledge level in all aspects of clinical data management in a clinical or research environment;
+ The incumbent can lead a study or project data management team independently;
+ The incumbent may lead complex project, desire to improve best practice, and is respected as a reliable partner in Clinical Project Teams and Study Teams;
+ Bachelor's degree (or higher), in the fields of Natural Sciences, Life Sciences, Informatics, Medical Documentation or related subjects;
+ At least 7 years of study and/or project level experience as a Data Manager in supportive and leading roles;
+ At least 2 years of experience should demonstrate full responsibility as the DM lead on studies/project(s);
+ Deep understanding of the drug development process;
+ Strong organizational skills and able to collaborate with minimal supervision;
+ Ability to work and lead effectively in a global environment;
+ Essential competencies identified include:
+ Focus, Drive Result, Manage Complexity, Plan & Align;
+ Other key capabilities like Collaborates and Instills Trust should be also displayed by the incumbent.
+ Basic SAS Programming knowledge, or other database experience, preferred;
+ Significant experience of using data management methodologies and technologies (e.g., electronic data capture, familiar with data warehousing);
+ Demonstrated understanding of regulation and guideline (e.g. ICH, GCP, European Clinical Trials Directive, Privacy rules [HIPPA]);
+ The incumbent is required to conduct him/herself in an appropriate manner.
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.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.