Senior Manager Clinical Operations; m​/f​/d

Job Summary and Location

Responsible for the strategic and tactical operational planning and execution of R&D sponsored clinical programs for all corporate-sponsored programs from Phase I to Phase IV.

Location:

Spain.

• Plan, coordinate, oversee, and conduct complex global clinical trials in one or more therapeutic areas.
• Collaborate in a global environment, applying best practices and knowledge of internal and external business issues to improve processes, standards, and services.
• Accountable for planning, driving, and monitoring protocol-related activities throughout the project lifecycle to meet timelines, budget, and quality expectations.
• Lead cross-functional teams and oversee CROs and vendor management, ensuring cross-functional teams jointly achieve trial objectives and goals.
• Understand agency requirements related to clinical packages and plans, managing functions such as CSR, TFLs, ISS, etc.
• Ensure inspection readiness and manage CAPAs related to clinical programs within Clinical Operations.
• Accountable for financial planning, budget, accruals, and forecast contributions.
• Prepare clinical program updates and contribute to them as needed.

• Advance degree in life sciences (graduate degree), e.g., Biology, Chemistry, Pharmaceuticals, or a medical background.
• At least 7 years of experience in clinical research within industry, with at least 5 years in clinical trial management.
• Understanding of GxP and global requirements.
• Strong project management skillsets.
• Excellent communication skills and ability to manage cross-functional teams.
• Ability to handle complex situations and drive solution-oriented thinking.
• Fluent in English.
• Excellent team player, able to work under high pressure and demonstrate pronounced resilience.
• Experience working in an international and cross-functional team.
• Ability to present and defend perspectives.
• Proficiency in Microsoft Project, Excel, and PowerPoint.

• Participate in relevant meetings.
• Plan and set up cross-functional meetings, vendor meetings, and other necessary discussions.
• Own and/or contribute to SOP development and reviews.
• Support sponsor oversight through participation in site visits, including Site Initiation Visits (SIVs) and Co-Monitoring Visits, as required.