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 (COM3)
The Clinical Operations Manager (COM) is a global role that provides expertise across all aspects of clinical study management and/or site management for assigned Phase I - IV studies. The COM operates in line with Good Clinical Practices (ICH-GCP), applicable regulatory and legal requirements and Bayer's standard operating procedures.
All activities will have a North American focus or are for studies conducted exclusively in North America.
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of the COM3 are to:
STUDY MANAGEMENT
Identify, implement, lead and manage the cross-functional study team, and represent the study team on the clinical team.
Responsible for managing all study related operational activities from an approved study concept to the final Clinical Study Report (CSR) to ensure study is conducted with high quality and within the given timeline and budget.
Provide input and contribute to the preparation of the study protocol and other core study documents in close collaboration with the study team.
Lead study risk levelling and risk mitigation strategies and, if applicable contribute to risk management activities of the clinical team.
Support development and implementation of integrated data review plan (IDRP) as well as ongoing data cleaning as defined in the IDRP.
Develop study related training in cooperation with respective functions, chair investigator meetings.
Responsible for developing and tracking the total external study budget and accountable for providing regular estimates to the clinical team and other stakeholders.
Oversee protocol feasibility activities; lead operational planning and tracking of site feasibility, support analysis of feasibility data and develop study timelines incl. enrollment projections and study milestones.
Develop and implement patient recruitment and retention strategy in close collaboration with the study team.
Oversee and manage forecasting of study supplies.
Manage the selection and oversight of external suppliers.
SITE MANAGEMENT OVERSIGHT
Lead and oversee all operational aspects of site management on 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 and Risk Based Quality Management strategy with regards to monitoring and operational aspects.
Responsible and accountable for developing the monitoring plan and 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.
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 key opinion leaders to expand/maintain clinical research partnership opportunities through executive committees, steering committees and data monitoring committees.
Cross functional collaboration to ensure alignment of priorities and deliver the portfolio.
Influence and challenge internal and external factors to improve clinical research delivery.
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 the study level.
Support during internal Audits and Regulatory Inspections to ensure a successful outcome. Responsible for resolution of study conduct related findings.
Responsible for set-up, regular filing and completeness of study documentation. Oversee completeness of eTMF and conduct QC for accuracy, completeness, and adherence to ICH/GCP and Bayer QSDs.
OTHER
Participate in or lead 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 thought leaders and strategic partners.
WHO YOU ARE
Bayer seeks an incumbent who possesses the following:
Required Qualifications:
Bachelors Degree
Thorough understanding of drug development process, including monitoring, regulatory requirements, data management and budgeting
Proven leadership in initiating and completing clinical studies
In-depth knowledge of Good Clinical Practices (GCP), federal and international regulations and guidelines
Ability to familiarize with new fields of exploration in diseases or therapeutic areas
Strong planning, organization, attention to detail and excellent follow through
Success in leading diverse, virtual teams and fostering a collaborative team culture without hierarchical authority
Effective communication, negotiation, and issue resolution skills
Thrives in ambiguous and collaborative environments and embraces change
Strong problem-solving skills and resilience in managing obstacles
Preferred Qualifications:
Drug Development Project Management experience with 5 years Pharmaceutical Industry experience
2 years of Site Management experience
Employees can expect to be paid a salary between $139,840.00 - $209,760.00.?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 5/14/2025.
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: 877346
Contact Us
Email: hrop_usa@bayer.com
