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.
Clinical Operations Manager (COM2)
The Clinical Operations Manager 2 is a regional role that provides expertise across all aspects of clinical site management and/ or study management for assigned Phase I - IV studies. The COM 2 operates in line with Good Clinical Practices (ICH-GCP), applicable regulatory and legal requirements and Bayer's standard operating procedures.
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of the COM2 are to:
STUDY MANAGEMENT
Lead and oversee all operational aspects of site management on a regional or study level from protocol feasibility to study archive.
Serve as the representative for site management on the core study team.
Contribute to the development of the protocol, study overview, monitoring strategy and Risk Based Quality Management with regards to monitoring and operational aspects.
Responsible and accountable for developing the monitoring plan and the study-specific training plan.
Key contributor in the development of recruitment and retention strategies and tools.
Act as key study contact for assigned countries. Responsible for overall deliverables regarding timelines, budget, and quality in assigned countries.
Ensure participating country commitment aligns with study commitments.
Provide the information required to effectively monitor and manage study activities, ensuring all relevant IT systems are updated with precise and current data.
Oversee monitoring activities and ensure sponsor oversight through monitoring report review and co-monitoring visits.
SITE MANAGEMENT
Act as primary contact for investigational sites.
Verify site qualification, ensure the Investigator, and site staff meet all aspects of study delivery and commitments from site selection through close out.
Train the Investigator and site staff on study protocol, relevant systems and operational aspects of study conduct.
Monitor trial conduct in compliance with the study protocol, ICH-GCP and applicable regulatory requirements on time and quality. Ensure completeness of the Investigator Site File.
Prepare and conduct onsite and/or remote monitoring activities according to monitoring plan, including complete reporting and follow up.
CLINICAL CUSTOMER ENGAGEMENT
Cultivate and sustain customer relations with clinical trial sites, ensure effective communication, drive fit for purpose processes and work towards enhancing overall site satisfaction and engagement.
Establish and develop strong professional relationships with clinical investigators to expand/ maintain clinical research partnership opportunities.
Cross functional collaboration to ensure alignment of priorities and deliver the portfolio.
Influence and challenge internal and external factors to improve clinical research delivery.
STUDY START-UP
Lead study start-up activities in collaboration with local team.
Provide input on site activation strategy.
Collect and perform quality review of essential documents on country level such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc.
Compile and submit submission dossier (country dependent).
Obtain any required approvals for relevant site documents (e.g., informed consent, financial disclosures).
Prepare and distribute site start up documentation including Investigator Site File.
Ensure timely filing of study documents at country and site level in Trial Master File (TMF).
Ensure awareness of related local regulations and support maintenance of country intelligence.
Provide study status monitoring and systems support (e.g. act as technical expert)
Coordinate site and vendor payments.
QUALITY
Proactively identify and communicate issues, taking appropriate action to prevent the recurrence of identified deviations. Ensure timely and comprehensive resolution of issues that may affect compliance or the quality of study related activities or data.
Maintain corrective action and preventative action plans (CAPAs) at country level.
Contribute to the preparation, conduct, and follow-up of Site Audits and Regulatory Inspections to ensure a successful outcome.
Oversee completeness of country/site level eTMF and conduct QC for accuracy, completeness, and adherence to ICH/GCP and Bayer QSDs.
OTHER
Participate in expert working groups, project standard teams, and similar initiatives.
Contribute to global process improvement efforts.
Share knowledge and experience with a coaching mindset
Maintain therapeutic and technical expertise to enable discussions with investigators and site personnel.
WHO YOU ARE
Bayer seeks an incumbent who possesses the following:
Required Qualifications:
Bachelors Degree or combination of education and many years of site management experience
Fundamental project management skills
Awareness & understanding of cultural and regional differences
Communication, oral presentation & interpersonal skills
Decision making
Issue resolution
Planning and organization, time management, prioritization
Thrives in ambiguous and collaborative environments and embraces change
Effective written and verbal English communication skills
Willingness to travel to sites, study meetings, local and international level
Preferred Qualifications:
Bachelors Degree with 4 years of monitoring and site management experience;
Combination of education and minimum 8 years of monitoring and site management
Employees can expect to be paid a salary between $128,480.00 - $192,720.00. Additional compensation may include a bonus or commission (if relevant).? Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..?
This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors.
This posting will be available for application until at least 7/27/2026.
YOUR APPLICATION
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders.
Bayer is an E-Verify Employer.
Location: United States : Residence Based : Residence Based
Division: Pharmaceuticals
Reference Code: 875843
Contact Us
Email: hrop_usa@bayer.com
