Clinical Operations Manager (COM2)

Bayer•Tulsa, OK

2d•$128,480 - $192,720•Remote

About The Position

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.

Requirements

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

Nice To Haves

Bachelors Degree with 4 years of monitoring and site management experience
Combination of education and minimum 8 years of monitoring and site management

Responsibilities

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.
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.
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.
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.
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.
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.