Job Description:

Description

ESSENTIAL FUNCTIONS:

1. Recognize, exemplify and adhere to ICON GPHS's values which center around our commitment to People, Clients and Performance.


2. As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.


3. 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.


4. Read, ensure understanding and adhere to all assigned ICON GPHS SOPs and working procedures.


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


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


7. 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.


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


9. Building Relationships: Establishes good relationships internally and externally.


10. 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.


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


12. Robust Thinking: Identifies the key elements of a situation and any gaps and inconsistencies in data. Makes rational judgements from available information and analysis.


13. Ensure that study authorization activities are in alignment with department metrics and goals.


14. Where necessary, support team in study start up related issues within his/her region.


15. Oversee management of submissions (start-up and ongoing) and study start-up activities (as applicable) to ensure they are conducted in an effective manner, meeting sponsor timelines, contractual requirements and expectations; and in adherence with ICON GPHS SOPs and appropriate regulations.


16. Oversee management of studies in regards to Department goals set regarding quality, timelines and metrics.


17. Provide financial oversight to ensure appropriate profitability.


18. Monitor and manage staff workload to optimize resource utilization.


19. Effectively manage staff through open and timely sharing of information, regular performance review and feedback, and setting of clear goals and objectives. Ensure individual and team achievements are appropriately recognized.


20. Provide mentoring and training to staff ensuring that all necessary training is provided according to job title; act as a role model to team members.


21. Continually develop staff to reach their potential through evaluation and monitoring of their development plan.


22. Continually assess opportunities for process improvements and develop and monitor process change implementation.


23. Proactively participate in the selection and recruitment of suitable and qualified staff.


24. Develop supporting staff skills, encourage growth and provide regular performance feedback.


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


26. Proactively identify and implement process improvement initiatives as appropriate.


27. Liaise with other managers within Clinical Operations to improve the effectiveness of the organization.


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


29. 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.


30. Maintain confidentiality of management and personnel information, as appropriate.


31. Represent Clinical Operations in sponsor and internal audits.


32. Perform tasks and duties as assigned by Senior Management.

Qualifications

Experience1. Business Degree, or equivalent combination of education, training and experience in an administrative or research work environment. Experience supporting clinical research project teams for a CRO/Pharmaceutical/Biotech company is desirable. (preferred)
2. An understanding of quality control as it relates to regulatory documentation requirements is preferred. (preferred)
3. Exceptional written and oral communication skills. (preferred)
4. Ability to problem-solve. (preferred)
5. Ability to work well in a team environment as well as independently as needed. (preferred)
6. Proficient in Microsoft Office Suite and comfortable with Excel. (preferred)

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) Apply Now