[Hiring] Clinical Operations Manager 2 @Bayer

Role Description

The COM 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.

The COM 2 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. The COM 2 must acquire knowledge and adequate training for work packages assigned and become proficient in independently executing assigned responsibilities.

Qualifications

• Healthcare related Bachelor’s Degree or equivalent
• Minimum 4 years of monitoring and site management experience, or a combination of education and minimum 8 years of monitoring and site management experience
• Experience in Spain
• Effective written and verbal English and Spanish communication skills
• Fundamental project management skills
• Decision making and issue resolution skills

Requirements

• 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
• Responsible 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
• Ensure participating country commitment aligns with study commitments
• Provide the information required to effectively monitor and manage study activities
• 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 and ensure the Investigator and site staff meet all aspects of study delivery
• 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
• Prepare and conduct onsite and/or remote monitoring activities according to the monitoring plan
• Cultivate and sustain customer relations with clinical trial sites
• Establish and develop strong professional relationships with clinical investigators
• Cross-functional collaboration to ensure alignment of priorities
• 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
• Compile and submit submission dossier (country dependent)
• Obtain any required approvals for relevant site documents
• 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
• Coordinate site and vendor payments
• Proactively identify and communicate issues, taking appropriate action to prevent recurrence of identified deviations
• 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
• Oversee completeness of country/site level eTMF
• QC for accuracy, completeness, and adherence to ICH/GCP and Bayer QSDs

Benefits

• Home based in Spain
• Regular employment type
• Regular work time

Company Description

Location: Spain : Cataluña : Barcelona

Application Period: 15 días

Reference Code: 891581

Division: Pharmaceuticals

Functional Area: Clinical Development & Operations

Position Grade: VS 1.2