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Clinical Operations Partner Lead 

Purpose:

The Team Catalyst will support the whole SM organization in a specific country. Accountable for applicable Phase I to IV studies' as well as Oncology and Cell & Gene Therapy studies’ monitoring, site management resources and activities in their specific country from study feasibility to archival. Contributes to and implements the strategic direction of Site Management within their specific country or region to ensure quality delivery of study data in line with quality, legal, regulatory and compliance requirements.

Oversees successful and efficient site management and monitoring activities and global CO support within the country, critical in delivering quality clinical trial data and achieving study country commitments for the successful development and approval of investigational drugs across multiple geographies.

Responsible for leading & coaching via community forums, coaching on the field, peer to peer mentoring and personalized coaching. 

Scope (global, regional or local): Local or regional

Key Tasks:

• This role is a permanent role and will report directly to the SM cluster/country  leads.
• Oversees team of 15-25 insourced employees
• 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 implementation of actions at country level to improve upon audit and inspection findings. Actively participates in the discussion for development of the clinical trial environment in the country including participation in relevant associations and e.g. development of new legislation.
• Collaborates with local/regional internal and external stakeholders to enhance clinical investigator relationships
• Responsible for ensuring competency training and professional development of all Site Management employees. Align local training needs and best practices with CO Training strategy and contribute to delivering training programs. Recruiting insourced personnel, identify diverse talents. Requires thorough understanding of global and local processes, drug development and associate Global Standard Operating Procedures (SOPs).
• Responsible for building a high performing Site Management team, adopting the principles of 'Dynamic Shared Ownership’ (DSO), encourage safe to try decisions.
• Recruiting insourced personnel, identifying diverse talents.

Key Working Relation:

• SM Leads, Cluster Leads, Team Leads, Country Medical Director, Medical Affairs and MSLs, Pharmacovigilance, Regulatory Affairs, Market Access, Country BU Heads & Marketing, Legal, Controlling, Procurement, HR, Accounting, Communication,
• Other functions in CD&O
• CRO local managers, development partners, global & local vendors and external suppliers, pharmacy industry associations, patient associations, University Hospitals and Sites, Information Services Departments.

Qualification & Competencies:

Healthcare related Bachelor’s degree (or equivalent) with 10 years’ relevant healthcare experience including 5-7 years’ relevant clinical development or clinical operations experience.

Ever feel burnt out by bureaucracy? Us too. That’s why we’re changing the way we work— for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https://www.bayer.com/en/strategy/strategy

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