Job Description
Precision for Medicine is growing! We are looking for an experienced Senior Manager, Clinical Trial Management to cover the line management of our Clinical Trial Managers. The position can be covered fully remotely from Spain.
Position Summary:
- The Senior Manager Clinical Trial Management (Sr. MCTM) offers an additional development path for clinical research professionals. Responsibilities focus on the management and career development of the organization’s Clinical Trial Managers (CTM, Sr. CTM, Principal Clinical Trial Managers (PCTM) and MCTMs, as well as supporting the development of departmental initiatives to strengthen the quality and productivity of Clinical Trial Management operations.
- This position requires the ability to independently lead, manage, and motivate a team of CTMs and Managers (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. The Manager will ensure studies are conducted in accordance with applicable SOPs, regulations, and ICH GCP principles.
Essential functions of the job include but are not limited to:
- 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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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
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