Comply with applicable EHS regulations and procedures.
Participate in the site's EHS performance by reporting risks, malfunctions or improvements
Participate in mandatory EHS training
Keys to Success:
Education
1. Life science or medical graduate or other relevant qualifications.
2. Minimum: CRA graduated
Experience
3. Experience of minimum 1 year (ideally 2 years) of Lead CRA coordination of clinical activities/site management activities for the set up and running of international registrational studies (multiple sites/countries).
4. Experience as a Field CRA monitor for at least 3 years (CROs or Pharma Industry)
5. Excellent Knowledge of Good Clinical Practice (GCP), ICH regulations.
6. Experience in preparing clinical study documentation for study set up, maintenance and closing
7. Experience in managing and developing relationships with Contract Research Organizations (CROs). Global studies (multiple countries/sites) experience
8. Previous experience in the Therapeutic area of studies (Neuroscience, Oncology or radiopharmaceutical compound) is a plus
Knowledge, Skills, Abilities
9. Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
10. Good planning and organizational skills to enable effective prioritization of workload
11. Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
12. Capable of working effectively in a changing environment with complex/ambiguous situations
13. Familiarity with the practices, processes, and requirements of clinical monitoring
14. Good judgment and decision making skills
15. Effective oral and written communication skills, including English language proficiency
16. Capable of evaluating workload against project budget and adjusting resources accordingly
17. Sound financial acumen and knowledge of budgeting, forecasting and fiscal management
18. Strong attention to detail
19. Solid understanding of relevant regulations ICH/GCP, FDA guidelines, etc.
20. Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc
Working Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
21. Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
22. Able to work upright and stationary for typical working hours.
23. Ability to use and learn standard office equipment and technology with proficiency.
24. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
25. May require travel. (Recruiter will provide more details.)
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