Clinical Operations Manager 2

Clinical Operations Manager 2

Position Purpose

We are seeking a dedicated Clinical Operations Manager (COM) to join our team in a regional role. The COM will provide expertise across all aspects of clinical site management and study management for assigned Phase I – IV studies. This position operates in accordance with Good Clinical Practices (ICH-GCP), applicable regulatory and legal requirements, and Bayer’s standard operating procedures.

Your new role and responsibilities

You may be assigned work packages in areas of study start-up, site management and study management on a regional level. Either one or a combination of these work packages may be allocated to the position holder according to expertise, skill set and capacity requirements in a flexible way. You must acquire knowledge and adequate training for work packages assigned and become proficient in independently executing assigned responsibilities.

A work package is any combination of the individual responsibilities listed below. Work packages are not fixed, can be allocated per study, and distributed within the team. Allocation and distribution of responsibilities must adhere to Bayer’s standard operating procedures, including any requirements for independent review and oversight.

Study Management

• Lead and oversee operational aspects of site management from protocol feasibility to study archive.
• Act as the representative for site management on the core study team and ensure alignment with study commitments.
• Develop the monitoring plan and study-specific training, while contributing to protocol and monitoring strategy development.
• Serve as the key contact for assigned countries, ensuring deliverables meet timelines, budgets, and quality standards.

Site Management

• Act as the primary contact for investigational sites, verifying qualifications and ensuring compliance throughout the study lifecycle.
• Train site staff on study protocols and monitor trial conduct for adherence to ICH-GCP and regulatory requirements.

Clinical Customer Engagement

• Cultivate relationships with clinical trial sites and investigators to enhance collaboration and satisfaction.
• Collaborate cross-functionally to align priorities and improve clinical research delivery.

Study Start-Up

• Lead study start-up activities, providing input on site activation strategies and ensuring essential documents are collected and reviewed.
• Coordinate site and vendor payments and maintain awareness of local regulations.

Quality Assurance

• Proactively identify and resolve issues affecting compliance and study quality.
• Maintain corrective action plans and contribute to site audits and regulatory inspections.

Collaboration and Engagement

As COM, you will play a key role in building strong relationships both internally and externally. Internally, you will collaborate with local and regional teams, including other COMs, medical affairs, pharmacovigilance, regulatory affairs, and legal functions, ensuring seamless study execution.

Globally, you will connect with study team members and quality assurance to align strategies that drive clinical research forward. Externally, you will engage with site personnel, third-party vendors, health authorities, and Institutional Review Boards (IRBs) to ensure compliance and foster collaboration with thought leaders and steering committee members.

Your ability to communicate effectively and build relationships will be essentiall in contributing to the success of our clinical trials. Join us and make a meaningful impact in clinical research!

Who Are You?

We’re looking for a passionate and experienced COM to join our team! Here’s what you bring to the table:

• A Bachelor’s Degree in a healthcare-related field or equivalent experience.
• 4+ years of monitoring and site management experience, or a combination of education and a minimum of 8 years in the field.
• Strong project management skills and the ability to navigate cultural and regional differences.
• A willingness to travel to sites and study meetings, both locally and internationally.
• Excellent communication, presentation, and interpersonal skills.
• A knack for decision-making and issue resolution.
• Exceptional planning, organization, and time management abilities.
• A collaborative spirit that thrives in dynamic environments and embraces change.

What Bayer offers you

As a modern employer, we prioritize the well-being of our employees, helping you achieve a balance between career development and personal life. You will enjoy excellent employment conditions, including:

• A monthly gross salary ranging from €5.530,- to €6.900,- based on a 38-hour workweek, depending on your experience and qualifications.
• Performance-based bonus
• 8.33% holiday allowance
• 25 days of paid leave, with the option to purchase up to 10 additional days.
• If you work from home, Bayer provides the necessary tools and a monthly internet allowance
• Pension scheme
• Bicycle lease plan

Sandra.deKlerk.ext@bayer.com