This job is with Bayer UK & Ireland, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
Please do not contact the recruiter directly.
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'.
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.
Position Purpose:The Clinical Project Support Specialist (CPSS) role is designed to provide comprehensive operational support to the global study team. This role is pivotal in ensuring the smooth execution of phase I-IV clinical trials by offering administrative, logistical, and operational support on a global level.
Major Tasks of Position:Administration & Logistics:
- Create and maintain different study documents and tools (e.g., Study Guide documentation, different study instructions, study newsletters, financial disclosure summary tables, invoices) to support all different roles of the study.
- Update study Q&A and Action log.
- Set-up and maintain different project and study platforms/software e.g., SharePoint/TEAMS, OneNote.
- Support audits and inspections according to company policy and SOPs.Meeting Support & Communication:
- Act as a Study Team key contact with eTMF Specialist/System Specialist.
- Support to set up and manage Clinical/Study Team and Steering Committee meetings (e.g., preparing, drafting, presenting slides, recording, taking minutes and attendees list).Operating Trackers/Reports:
- Maintain different study trackers to keep study information up to date and ensure study oversight/quality at different study levels, including vendor trackers and logistics.System Management:
- Upload/file/review different study level documents in eTMF and provide updates/reports on eTMF status.Vendor/CRO Handling:
- Support outsourced studies, maintain oversight of CRO eTMF, Veeva by ongoing QC in the systems if needed.Qualifications and Requirements:The clinical development study and project coordination activities are accomplished through a strong skillset, understanding of clinical development and global operating processes of drug development as well as in-depth knowledge of ICH-GCP and international regulations.
Bachelor's degree or equivalent in a relevant field with 1+ year of experience in clinical research/development ideally in the pharmaceutical industry.
Candidate ideally brings experience working with VEEVA System.
The incumbent must have the ability to manage multiple high-level parallel tasks; work unsupervised, have effective computer skills, possess the ability to apply new techniques and technology, have excellent knowledge of all Microsoft Office programs, and strong prioritization skills.
The incumbent must display excellent planning and organizational skills, innovativeness, and keen attention to detail and excellent follow through. The incumbent must have strong interpersonal, communication and team working skills and must be able to manage high-level professional relationships with internal and external customers, like international teams, 3rd parties and people in a global environment. Excellent communication and interpersonal skills, with fluency in English (both written and oral). Additional language skills are a plus.
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: [[mfield3]] Division: [[filter1]] Reference Code: [[id]] #LI-DNI
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