Precision for Medicine is a global Clinical Research Organization with uniquely integrated offering which enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. 

Due to our continued growth we are seeking a Regulatory and Start Up Specialist based in Spain to join our growing team. For this role its key for candidates to have contracts and budgeting negotiation experience for Spain.

Essential functions of the job include but are not limited to:

Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.

The ideal candidate will have:

Minimum Required:

Other Required:

Preferred:

• Lead, mentor, coach, and manage CTMs/PCTMs/MCTMs to support skill development, performance, and career growth in line with Precision for Medicine quality standards.
• Provide leadership and oversight across clinical programs, including clinical trial oversight where applicable.
• Partner with Clinical Operations leadership and cross-functional teams to improve CTM processes, quality, consistency, efficiency, and KPI achievement.
• Collaborate with Resourcing to ensure appropriate staffing and resource allocation.
• Set strategic action plans and provide ongoing performance feedback, technical guidance, and developmental support to direct reports.Ensure CTMs have appropriate training, tools, systems access, and resources to meet role expectations.
• Identify quality risks, recommend corrective actions, and escalate issues as needed to leadership, PMs, and DPMs.Ensure compliance with SOPs, regulatory requirements, project plans, and quality standards.
• Develop and update Clinical Operations SOPs, templates, and work instructions; contribute to clinical documentation as needed.
• Support CTM hiring, onboarding, and training in collaboration with HR and Learning & Development.
• Promote Precision’s values and complete additional duties as assigned by leadership.

Qualifications:

Minimum Required:

• Graduate, postgraduate, 4-year college degree or equivalent experience ideally in a scientific or health related field 
• 10 years of industry experience in clinical research, including clinical operations experience in a pharmaceutical company or CRO, or proven competencies for this position 
• Experience in managing clinical aspects of complex and global trials 
• Previous CTM line management experience  
• Working knowledge of ICH GCP guidelines and the clinical development process 

Other Required:

• Excellent communication and interpersonal skills to effectively interface with others in a team setting 
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
• Ability to travel domestically and internationally including overnight stays

Competencies:

• Direct work experience in a global, cross-functional clinical management environment
• Proven experience in people management with a high capacity for Emotional Intelligence
• Ability to develop, coach and mentor CTM staff and hold personnel accountable to achieve goals and address training needs
• Proven experience in risk management and change management
• High level of integrity and must inspire and demand the highest standards from assigned CTMs
• Exhibits high self-motivation, and the ability to work and plan independently as well as in a team environment
• Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Excellent presentation, verbal, and written communications skills
• Demonstrated successful independent negotiation and conflict management strategies
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and team

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