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Junior Clinical Trial Posting Manager
hace 1 mes
Junior Clinical Trial Posting Manager
Position purpose:
Manage and publicly disclose clinical trial information into clinical trial registries and posting of clinical trial result summaries on company owned and public international websites based on internal rules and external guidelines, obligations, and legislations for the entire Bayer product portfolio, including regular updates and maintenance of the disclosed information according to internal and external requirements Contribute to the development and continuous update of Bayer's disclosure strategy for clinical trial information based on cross functional internal requirements and the rapidly changing external legal and regulatory requirements, industry commitments and obligations. Disclose information on Bayer s Clinical Trials at high level quality by fully complying to the related Quality Assurance processes.
Scope:
Global
Key tasks:
Collection of the necessary data for public disclosure of clinical trial information within Bayer: design forms/templates, request information, track responses, disclose information Provide up to date and consistent Clinical Trial Posting data on all required company owned and public websites Formal quality control of publicly disclosed clinical trial information according to the QA process established Check consistency of disclosed information for a study, i.e. consistency of disclosed information on different internet sites and of registry and results information for the same study Check disclosed information for inappropriate wording, especially for promotional language Check compliance to internal disclosure process and to external legislations and obligations Contribute to continuous monitoring for changing and new Clinical Trial Posting requirements to keep the Global Development Management up to date and to adjust and update internal rules and processes accordingly
Key relations:
Position holder directly interacts with Study and Project teams, with Global Development Therapeutic Area Heads, Global Study Management Head, Global Regulatory Affairs Therapeutic Area Heads, and other Development/ MA/ PV and CH Senior Managers.
Qualifications & Competencies:
Degree in Medicine, Life Sciences, or Natural Sciences or equivalent professional experience Experience in clinical development with significant experience related to clinical trials, e.g. as Study Manager, CRA, or Data Manager Solid understanding of global legislations, regulations and guidelines Understanding of ICH/GCP regulations Solid understanding of drug development process over different stages Solid understanding of IT processes and Systems used in Clinical Development, especially Clinical Trial Management Systems, Document and Workflow Management Systems Strong skills in English language, both oral and written (fluent speaking mandatory) Solid knowledge of the Bayer product and development portfolio Good written and oral communication skills Good project management skills Good player in global, cross functional teams Good ability to think and act with customers in mind Good ability to work self organized and independently Good ability to overcome complexity and to provide oversight Good ability to accurately work on detail level
YOUR APPLICATION
This is your opportunity to tackle the world's biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.
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. We are committed to treating all applicants fairly and avoiding discrimination.
Location:
Spain : Cataluña : Barcelona
Division:
Enabling Functions
Reference Code:
819143
