FSP Country Approval Specialist

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Essential Functions:

•   Support 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, Clinical Operations teams, and other stakeholders 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.

•   Review and provide feedback to management on site performance metrics.

•   Ensure accuracy and completeness of the eTMF for assigned sites during start up

Technical/Functional (Line) Expertise:

•   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 or FDA and ICH-GCP guidelines for conducting clinical research

Minimum Requirements

•   Bachelor's degree or equivalent.

•   2+ years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.

• Activation experience required.

•   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.

Leadership

•   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 distill 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