Manager, Site Start Up

Summary

Join Precision for Medicine, a Clinical Research Organization, as a Manager, Site Start Up based in South Korea, overseeing Regulatory and Start Up Specialists across South Korea, Taiwan, and Australia. You will develop, mentor, and manage SSU personnel, ensuring quality standards and compliance. Responsibilities include resource management, performance reviews, and contributing to training plans. The role requires a Bachelor's degree in life sciences or a related field, at least 6 years in clinical research with extensive Site Start-up experience, and demonstrated leadership. Preferred qualifications include an advanced degree and CRO experience. The position offers opportunities for career development and impacting positive change within the company.

Requirements

• Bachelors degree in life sciences or related field or equivalent combination of education, training, and experience
• A minimum of 6 years in clinical research including extensive experience of Site Start-up
• Leadership experience or proven competencies for this position
• Demonstrated knowledge of GCP/ICH guidelines and the clinical development process
• Demonstrated competence in people management
• Experience working in team environment with resource management experience
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) and clinical software experience (CTMS, eTMF, EDC etc)
• Strong communication and interpersonal skills to effectively interface with others in a team setting
• Strong organizational skills, attention to detail, and a customer service demeanour
• Proven experience in strategic planning, risk management and change management
• Fluency in English

Responsibilities

• Develop, mentor, manage and coach SSU personnel to ensure Precision’s quality standards are maintained
• Advocate individual career development, and individual responsibility/accountability
• Maintain routine 1:1 meetings with SSU personnel for management of assigned tasks and career development
• May serve as SME support for Site Start up activities
• Ensure SSU personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
• Ensure that SSU personnel have the proper resources, training, materials, and access to systems to deliver on the expectations of their position
• Contribute to development of training plans and hold SSU personnel accountable to achieving training goals or addressing training needs
• Ensure SSU personnel are in compliance with administrative tasks (i.e., time entry, corporate-level training, time/billing compliance and travel expense and expense reporting compliance, as applicable)
• Participate in the interview process for new SSU personnel by conducting CV review and participating in the interviewing process
• Support on-boarding training for new SSU personnel in conjunction with Human Resources, Training and other functional areas
• Contribute to development of robust standards and processes for the staff and ensure consistent, quality execution among the SSU personnel
• Active participant in resourcing of SSU personnel and manage FTE allocation per project to ensure time/work billed is in alignment with project budget and assumptions, with continued assessment and adjustment as needed
• Provides on-going feedback, development and coaching of line reports including annual performance reviews
• Active participant in planning and conducting department meetings to provide routine high-level communication to SSU personnel
• Assists with internal initiatives
• Performs other duties as assigned by management

Preferred Qualifications

• Advanced degree in life sciences or related field
• Experience in CRO environment
• Ability to work closely with business unit leadership to understand customer's needs
• Demonstrated analytical skills and business acumen
• Strong presence with the ability to confidently deliver presentations internally or for clients
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective
• Ability to lead and inspire excellence within a team
• Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
• Results oriented, accountable, motivated and flexible
• Proven ability to effectively influence, negotiate, and manage conflict
• Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills
• Strong presentation, verbal and written communications skills
• Occasional travel may be required