[Hiring] FSP Site Start Up Specialist @Thermo Fisher Scientific

Role Description

Supporting the facilitation of site start up and communication with internal and external team members to ensure prompt site approval and study timelines are achieved.

• Support sites and study teams to achieve rapid site start up.
• Work directly with assigned sites on all site related essential document collection and review.
• Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and deliver processes.
• Ensure standards are applied to the SSU processes across projects.
• Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc.
• Promptly recognize and improve potential site activation delays and escalate to appropriate team members.
• Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
• Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
• Review and provide feedback to management on site performance metrics.
• Ensure accuracy and completeness of the eTMF for assigned sites during start up.

Qualifications

• BS degree or international equivalent.
• 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
• Ability to explain data to facilitate decision making processes to be data driven.
• Knowledge and understanding of clinical study protocols and essential documents.
• Strong organizational skills, decision making, communication and negotiation skills.
• Proficient in Microsoft Excel, Word, and PowerPoint.

Requirements

• Understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc.).
• Understanding of Clinical Trial Agreements, budgeting and fair market value principals.
• Knowledge of FDA and ICH-GCP guidelines for conducting clinical research.

Benefits

• Demonstrated ability to work across functions, regions and cultures.
• The ability to inspire, motivate and drive results.
• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing.
• Proven skills as an effective team player who can engender credibility and confidence within and outside the company.
• Ability to distil complex issues and ideas down to simple comprehensible terms.
• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.