Directeur Site Management et Monitoring (F / M)

Pfizer; Paris; Sur place; EUR 90 000 - 160 000; Plein temps

Résumé du poste

A leading company in the pharmaceutical field seeks to hire a Director of Site Management and Monitoring to oversee clinical trial operations and manage site resources across regions. This pivotal role requires strong leadership, extensive clinical research experience, and skills in stakeholder engagement and resource management to ensure compliance and success of clinical studies.

Qualifications

• Fluency in English; local language skills are advantageous.
• Minimum 10 years of experience in clinical trial methodologies within pharma or CRO.
• Extensive clinical research experience needed.

Responsabilités

• Lead and coach resources within assigned regions.
• Oversee job functions and ensure compliance with training requirements.
• Manage relationships with external vendors and CROs.

Connaissances

People management

Leadership

Risk management

Stakeholder engagement

Communication

Resource management

Adaptability

Formation

BS / BSc / MS / MSc

PhD / MD

Description du poste

The Director of Site Management and Monitoring (DSMM), in partnership with the Director of Clinical Site Operations (DCSO), is accountable for ensuring appropriate site management and monitoring resources (e.g., Site Care Partner (SCP), Clinical Research Associate (CRA), Site Monitor) are in place to deliver on both country and site-level end-to-end study start-up, management, and monitoring activities in line with study milestones in the designated countries / clusters / regions. The DSMM also provides line management and oversees the job functions of these roles.

The DSMM supports the DCSO, who is accountable for overall site operations and site management and monitoring activities within designated countries / clusters / regions. They supervise requirements for sites to ensure participant safety and quality of study execution, complying with applicable laws, Good Clinical Practice, and Pfizer standards.

The DSMM collaborates cross-functionally with teams such as Study Start-Up (SUPM, SAP, CTA, ICL), Optimization, Analytics, Recruitment Solutions (OARS), Patient Recruitment, and Study Management. They contribute to country and site selection, facilitate Clinical Trial Application / IRB / EC approvals, and execute investigator site/recruitment strategies for end-to-end study start-up, management, and monitoring activities.

The DSMM leads, contributes to, and implements strategic initiatives representing GSSO Leadership, shaping the clinical development environment within designated regions to meet Pfizer’s clinical development goals. This includes managing risks, engaging with local leaders and authorities, participating in industry forums, and building relationships with investigational sites to promote ethical and efficient clinical research, including DCT readiness and virtual monitoring.

The role may be aligned with specific assets or centralized services, serving as a strategic point of contact for planning, quality events, and inspections. Additionally, the DSMM provides insights on regional trends, develops analyses, and offers mitigation options for trial conduct.

**JOB RESPONSIBILITIES**

1. Lead and coach resources within assigned regions.
2. Accountable for the growth and development of the Site Operations organization.
3. Oversee job functions and ensure compliance with training requirements.
4. Coordinate with FSP Managers to oversee FSP roles.
5. Perform joint site visits to assess performance when required.
6. Resolve site / country / region issues to maintain quality and relationships.
7. Establish clear priorities across regions.
8. Contribute to country/site selection and study design, communicating feedback effectively.
9. Oversee operational delivery, including site management and monitoring, safety, and quality.
10. Demonstrate Therapeutic Area expertise as needed.
11. Ensure timely and quality site start-up and activation.
12. Mitigate deficiencies in trial conduct to enhance quality and safety.
13. Identify and enable virtual monitoring capabilities.
14. Share regional issues and trends with stakeholders.
15. Collaborate with local CROs and regulatory bodies to ensure compliance.
16. Build relationships with investigational sites and industry forums.
17. Promote GCP, ethics, and regulatory training locally.
18. Contribute to global strategies and initiatives.
19. Maintain proactive relationships with internal and external stakeholders.
20. Manage relationships with external vendors and CROs.
21. Drive resource management and monitor quality metrics.
22. Support budget management at regional levels.
23. Partner with R&D colleagues to oversee trial portfolios.
24. Collaborate with global and regional leaders and study teams.
25. Engage with OARS teams and external vendors as needed.

**QUALIFICATIONS / SKILLS**

Basic Qualifications

• Fluency in English; local language skills are advantageous.
• BS / BSc / MS / MSc or equivalent with extensive clinical research experience.
• PhD / MD or equivalent with extensive clinical research experience.
• Minimum 10 years of experience in clinical trial methodologies within pharma or CRO.

Skills

• People management and leadership skills.
• Ability to manage diverse teams and influence matrix environments.
• Risk management and continuous learning capabilities.
• Stakeholder engagement and communication skills.
• Effective resource management and coaching abilities.
• Willingness to travel as required.
• Adaptability to VUCA environments.
• Decisiveness and accountability in decision-making.

Pfizer is an equal opportunity employer and complies with all applicable legislation.

Handicap & Inclusion

Medical