Clinical Trial Manager: Country Operations Lead

Bristol-Myers Squibb; Madrid; On-site; EUR 55,000 - 75,000; Full time

Job summary

Bristol Myers Squibb seeks a Clinical Trial Manager to oversee end-to-end study operations at the country level, ensuring timelines, budget adherence, and quality. You will coordinate with global study teams and local cross-functional groups to deliver trials successfully.

The role emphasizes feasibility, site coordination, recruitment strategies, data integrity in CTMS/eTMF, and regulatory submissions across the country. Strong communication and problem-solving are essential.

Qualifications

• Experience leading end-to-end country-level trial operations.
• Ability to coordinate with global study teams and local country teams.
• Strong focus on timelines, budget, and quality standards.

Responsibilities

• Acts as the main country-level contact for global study teams.
• Implements local country feasibility and targets in collaboration with leadership.
• Plans and executes start-up timelines with GTAC and study team.
• Manages country-level patient recruitment strategy and enrollment targets.
• Leads risk mitigation and issue resolution with key stakeholders.
• Ensures data in CTMS and eDC is current and accessible.
• Prepares and validates study materials (protocol, ICF, patient materials).
• Supports site initiation, monitoring, and CAPA processes at country level.
• Coordinates regulatory submissions, ethics approvals, and HA interactions.

Skills

Clinical Trial Management

Regulatory Knowledge

Cross-functional Coordination

CTMS/eTMF Familiarity

Tools

CTMS

eTMF

Job description

Bristol Myers Squibb seeks a Clinical Trial Manager to oversee end-to-end study operations at the country level, ensuring timelines, budget adherence, and quality. You will coordinate with global study teams and local cross-functional groups to deliver trials successfully.

The role emphasizes feasibility, site coordination, recruitment strategies, data integrity in CTMS/eTMF, and regulatory submissions across the country. Strong communication and problem-solving are essential.