Clinical Project Support Specialist

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.
Senior Clinical project support specialist
Position Purpose:
The Clinical Project Support Specialist (CPSS) role is designed to provide comprehensive operational support to global study team. This role is pivotal in ensuring the smooth execution of phase I-IV clinical trials by offering administrative, logistical, and operational on global level. The incumbent will work closely with global study team members, and other key stakeholders on a global level to optimize study efficiency, compliance, and quality, contributing to the timely regulatory submissions and market approval of new medicines and medical devices
Geographical scope:
Global
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.
-Create, maintain, and manage multiple Study Contact Lists: Study/ Clinical Team, Vendor/ External suppliers, Study Organizations in Veeva.
-Update study Q&A and Action log.
-QSD tracker oversight (make sure that QSD list is available at certain, required timepoints).
-Set-up and maintain different project and study platforms/ software e.g., SharePoint/TEAMS, OneNote.
-Support Clinical/Study Team members with one ad hoc time tasks.
-Support audits and inspections according to company policy and SOPs.
EU - CTR:
-Support EU-CTR transition and all study submissions
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.
-Support organization of virtual/on-site Investigator meetings / Monitor meetings / Study Team meetings (e.g., Start-Up Camps and KOMs, weekly Study Team meetings, CLM's meetings)
-Contribute to departmental / company initiatives and special projects. Provide expertise and support project planning, project management and implementation of functional initiatives to improve processes.
Operating trackers/reports
-Maintain different study trackers to keep study information up to date and to ensure study oversight/quality at different study levels, including vendor trackers and logistics (e.g., EPRO
translations, vendor manual, devices, lab kits etc.).
-Create study specific reports (e.g., CART, Veeva, IRT etc.)
-Create and update other team study specific Trackers, that cannot be pulled from existing systems
System management
-Upload/file/review different study level documents in eTMF (from StM & SLM, but also from other functions if agreed with the Team).
-Provide updates/reports on eTMF status (in Study Team meetings/country calls/regular communications) and maintain oversight of eTMF quality/completeness (if agreed with the Team and depending on which reports that are provided by eTMF Specialist).
-Support eTMF closure (e.g. by ensuring availability of all documents uploaded to eTMF).
-Maintain IT systems list in Gemstone.
-Manage user accesses for different study systems (Bayer/vendor systems or updating information for vendor system access/portals such as IRT, Central Lab, ePRO vendor, adjudication vendor, SharePoint restricted area, TEAMS channels).
-Maintain and update Veeva/Gemstone entries.
Support VST transition (Veeva Study Training ) and request Training log annual update for Study Team Members.
Vendor/CRO handling
-Support outsourced studies, maintain oversight of CRO eTMF, Veeva by ongoing QC in the systems if needed.
-Manage requests for different study materials not provided by central labs /RR (bags, miniprotocols, manuals).  Coordinate logistics (orders, shipments, custom clearance) of trial supplies for sites (e.g. eCOA device orders and shipments, laboratory kits, manuals, miniprotocols, medical equipments, RR materials -if requested)
Contribution context:
Individual contributor
Work interactions:
The CPSS will interact on a global scale within the study team and clinical team. The CPSS sphere of influence and communication will include the the Study Manager(s), the Study Lead Monitor(s), Study Data Manager, Study Statistician, country teams, the IxRS & Medication Manager (IMM Legal, procurement, Pharmacovigilance, Insurance and other study team members (globally). Locally main contact are the Clinical Operations manager 3 and 4, Study manager and Study Lead monitors.
The CPSS will additionally liaise with external suppliers globally.
Value added to the success of the company:
The Clinical Project Support Specialist role is important for the clinical trials conduct by ensuring operational excellence and compliance. This position adds value by enhancing the efficiency and quality of study execution, facilitating effective communication and coordination among teams, and supporting the achievement of project and study milestones within planned timelines and budget.
Organizational relationships:
The Clinical Project Support Specialist reports to CTS Team Lead in GBS Barcelona .
Qualifactions:
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 +2 - 3 yrs. of experience in pharmaceutical industry, or clinical research/development.
Candidate must bring 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 show high level of flexibility, willingness to support the team, be able to manage complexity and have good analytical and problem-solving 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.
familiarity / experiences with clinical trial management systems and eTMF.
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:
820023

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