Manager, Site Start Up

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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 demeanor
• 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