Manager – Start Up

This is a fully remote position, open to applicants in Australia, +3 more countries.

📋 Description

• Oversee staffing and resources to guarantee optimal departmental utilization

• Lead study start-up teams to ensure adherence to project timelines

• Enhance and refine study start-up and essential document management processes while maintaining quality standards

• Assist in corporate initiatives and promote departmental growth

• Supervise, mentor, inspire, and assess direct reports, including handling HR matters, training, performance evaluations, and career development

• Maintain metric spreadsheets and deliver monthly updates to senior management

• Employ analytical skills to evaluate reports and feasibility during the study planning phase

• Retain a comprehensive understanding of the costs associated with study start-up tasks and staff sourcing

• Suggest cost-saving measures when appropriate

• Contribute to business development efforts, including assessing and defining proposal specifications

• Deliver presentations to clients as required

• Utilize technology and search capabilities for effective study planning

• Ensure staff awareness of company SOPs, industry regulations, and guidelines

• Conduct regular meetings with staff to ensure studies remain on course

• Operate within a global context and coordinate activities across multiple countries

• Manage staffing and resource allocation for newly awarded studies to ensure appropriate staffing and timelines

• Prepare forecasts for staff utilization throughout the duration of studies

• Ensure effective transition planning and communication with stakeholders regarding staff changes

• Provide guidelines for time entry and relevant training

• Identify clinical team tasks that fall outside the scope and ensure prior approval

• Review and provide guidance on Regulatory and Clinical Operations SOPs, WGs, and ADs related to study start-up

• Engage in corporate initiatives that support the company's success

• Share expertise with other Managers and pinpoint opportunities for increased productivity

• Develop training programs and implementation strategies for both own staff and other departments

• Create clear internal and external documentation and presentations

• Establish standardized processes for study start-up, maintenance, and closeout

⛳️ Requirements

• Bachelor's degree or its international equivalent in clinical, science, or a health-related field from an accredited institution; a licensed healthcare professional (e.g., registered nurse); or equivalent work experience required

• At least 5 years of experience in the clinical research industry

• A minimum of 2 years of experience in people management

• Analytical skills to assess metrics and feasibility data

• Experience in CRO, Device, and/or Pharmaceutical sectors is preferred

• Familiarity with FDA, European Regulatory, and EC procedures as applicable

• Capability to manage multiple tasks and meet deadlines in a dynamic, changing environment

• Understanding of ICH / GCP regulations

• Proficient knowledge of web-based communication tools for conferences and other IT systems necessary for the position

• Awareness of national/local health systems and cultural/professional practices relevant to the country/region where site start-up activities will occur

• Understanding of project management principles

• Proficient in verbal and written English

🏝️ Benefits

• Flexibility and balance to accommodate your personal life requirements

• Opportunities for professional growth and development