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Clinical Operations Manager 2 (COM2)

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

STUDY MANAGEMENT

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- 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

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- 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

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- 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

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- 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

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- Proactively identify and communicate issues, taking appropriate action to prevent the recurrence of identified deviations. Ensure timely and comprehensive resolution of issues that may affectcomp

📌 Clinical Operations Manager 2 (Barcelona)
🏢 Bayer
📍 Barcelona