Study Start Up Manager, Milan Milano

Study Start Up Manager, Milan
Milano
Lombardia, Milano

To coordinate, manage and facilitate the activities related to preparation, review and approval of country related and site level submissions in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards; and to ensure that study authorization roles and responsibilities are focused on quality optimization, efficiencies and cost containment.

- Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.

- *As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

- *Travel (approximately 25%) domestic and/or international

- Leadership: Sets a clear and convincing future direction, while communicating with clarity.

- Teamwork: Builds strong and effective teams, valuing different contributions; works with and through others, involving people in issues that affect them.

- Energizing & Developing Others: Creates an environment that motivates people; Identifies development opportunities for self and others; Acts as a coach and mentor and shares expertise.

- Delivery to Customers: Delivers high quality standards and strives for excellence; Acts in a proactive, flexible and responsive manner to customer needs.

- Building Relationships: Establishes good relationships internally and externally.

- Personal Effectiveness: Operates independently with a willingness to make decisions; Projects credibility and makes a professional and positive impression on others; Monitors progress and holds self and others accountable.

- Commercial Awareness: Understand the ICON business globally; Controls costs and thinks in terms of profit, loss and added value; Promotes ICON effectively in all interactions.

- Robust Thinking: Identifies the key elements of a situation and any gaps and inconsistencies in data.

Makes rational judgements from available information and analysis.

- *Observe the regulatory and EC/IRB environments and ensure the maintenance of an up-to-date database on EC and regulatory requirements

- Serve as Global Lead, as necessary

- Proactively identify and implement process improvement initiatives as appropriate

- *Liaise with other managers within Clinical Operations to improve the effectiveness of the organization

- Liaise with colleagues from all other departments to improve the effectiveness of the organization

- *Participate in business development activities and client meetings by assisting in the preparation and presentation of Clinical Operations information in Bid Defense meetings, Kick-Off meetings and business proposals

- *Maintain confidentiality of management and personnel information, as appropriate

- Represent Clinical Operations in sponsor and internal audits

- Perform tasks and duties as assigned by Senior Management

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