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KR - RiTA3 Production Testing - Do not Apply
Position: Major Tasks • This role is a permanent role and will report directly to the SM cluster/country leads. • Oversight of the service provided by a third party • Responsible for providing individuals in the country teams with the resources to achieve their objectives and commitments ensuring accountability for their responsibilities. Coaching is done via community forums, coaching on the field, peer to peer mentoring and personalized coaching. • Ensures hiring, compensation and advancement are in line with talent and job expectations, maximizing capabilities of insourced personnel within the FSP framework. • Confirms collaborative behaviors and costumer focus at key interfaces with internal stakeholders and external groups within the country. • Manages the internal Site Management budget and resources including indirect responsibility for insourced costs. Ensures efficient and adequate resources for each clinical trial. Performs capacity planning for site management activities to ensure resource alignment with global business needs and timelines. Ensures appropriate planning and use of insourced resources in the country. Oversees external study budget (external clinical grants) of the country. • Accountable for oversight for all site management activities and procedures for applicable Phase I-IV clinical trials as well as ONC & CGT studies in the country, from study feasibility to archival. • Ensures country objectives for study deliverables (e.g. number of patients and timelines) are set reliably starting at the feasibility phase. • Ensures oversight of country performance and proactively identifies and addresses potential issues and initiates appropriate measures. • Ensures clinical trials are conducted according to ICH-GCP, Declaration of Helsinki, local and global requirements, remaining current with local laws, regulations and guidances. • Ensures the delivery of high-quality study data to support regulatory submissions. • Is accountable that country's objectives and KPIs are met, providing local staff with the required resources to achieve his/her objectives and commitments. • Works with CROs to ensure proper oversight and support to outsourced trials. • Steers the implementation of the business strategy at country level. • Ensures quality of study conduct in the country is in line with requirements facilitating reasonable oversight. Assures site management procedures and activities are conducted according to Good Clinical Practices, the Declaration of Helsinki and in accordance with ICH-GCP and local requirements. Remains current with local laws, regulations, guidance and proactively communicate changes to relevant stakeholders. Actively supports Sponsor regulatory inspections. • Create a dynamic and collaborative environment that allows for ongoing adaptation, improved efficiency, and a focus on delivering high- quality study data while meeting regulatory requirements and ethical standards. • Provides business knowledge and operational excellence for the country. Identifies process improvement opportunities, shares best practices within CO to continuously improve global practices and eliminate redundancies. Leads or participates in Expert Working Groups and provides feedback on SOP updates. Steers identification and
Spoločnosť Bayer víta žiadosti o zamestnanie od všetkých jednotlivcov bez ohľadu na rasu, národnosť, pohlavie, vek, fyzické charakteristiky, sociálny pôvod, zdravotné postihnutie, členstvo v odborových organizáciach, náboženstvo, rodinný stav, tehotenstvo, sexuálnu orientáciu, genderovú identitu, vyjadrenia pohlavia alebo akékoľvek nezákonné kritérium podľa platnej legislatívy. Zaviazali sme sa zaobchádzať so všetkými uchádzačmi spravodlivo a vyhnúť sa diskriminácii.
Location:
Korea (Republic) : Seoul : Seoul
Division:
Pharmaceuticals
Reference Code:
830763