Job Title: Clinical Trial Manager When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have impact, and you'll be supported in achieving your career goals.
Remotely based in any major US city or proximity thereof with easy access to a major US airport How will you make an impact? In this position you will accelerate national adoption and integration of Thermo Fisher Scientific's B·R·A·H·M·S biomarker immunoassays (IVDs) through clinical studies and medical evidence generation demonstrating the value of our products in patient care. You will be responsible for all activities associated with the ICH GCP and SOP compliant execution of clinical studies in accordance with the clinical study roadmap of the business. You will cover the full spectrum of clinical trial related operations from initial protocol development to final study result reporting including the coordination of activities with internal collaborators and external collaboration partners.
What will you do? Complete clinical trial operations for the B·R·A·H·M·S biomarker clinical study program in the US Conduct national and regional activities aiming to generate supporting evidence for the clinical validity and utility of B·R·A·H·M·S biomarkers Work with experts in the field to design appropriate clinical study protocols for FDA registrations, new indications, use extension or use adoption of B·R·A·H·M·S biomarkers Review investigator-initiated study concepts keeping IP relevance in mind Provide clinical trial oversight for site selection and recruitment of prospective investigators for sponsored clinical trials and liaise with the study partners Manage the contracting process with external collaborators such as study sites and contract research organizations Curate critical metrics dashboard for clinical trial progress and provide status reports on clinical trial operations to leadership Create and track budget plans for clinical trial operations Create study materials and quality documentations according to internal GPD/SOPs and applicable national/international regulations Effectively partner with internal colleagues and external stakeholders in health economic and outcomes research evidence generation, including support for reimbursement and guidelines development and/or implementation Generate trial reports and contribute to the publication efforts in close collaboration with the Sr. Medical Affairs Manager and Medical Affairs Director Ensure scientific validity of Marketing and Sales materials as they relate to clinical studies How will you get here? Be a self-starter with a passion for the advancement of patient care through clinical research and scientific evidence generation.
Education
Masters degree from an accredited college or university in Health Science field is required PhD or other terminal degree in a scientific field with relevant clinical/scientific proven experience strongly preferred Experience
3-5 years previous experience in the medical device or diagnostics industry required
Applicable clinical trial management experience from prospective multi-center randomized controlled intervention studies at the patient level required
Work in clinical indications relevant to B·R·A·H·M·S biomarkers strongly preferred (e.g. infectious disease, women's health and oncology)
Knowledge, Skills, Abilities
Strong background in ICH GCP and other national/international regulations for the conduct of clinical trials as well as quality standards such ISO 13485 Good knowledge of CLSI guidelines as they relate to in vitro diagnostics Comprehensive skills in establishing and maintaining relationships with a wide range of external partners including physicians, pharmacists, and allied healthcare professionals as study investigators Keen interest in driving clinical practice improvements through innovative clinical trials and evidence generation Excellent problem solving and persuasion skills and the ability to create success by professionally presenting B·R·A·H·M·S biomarkers to both individuals and multidisciplinary groups. Capability for high-level scientific, creative and strategic thinking Demonstrated understanding of factors driving market access and how clinical evidence can support access decisions Ability to take initiative, be resourceful, and exercise astute clinical judgment to drive performance A history of operating with a sense of urgency and a drive for results Proactive communication across teams to assure alignment, collaborative relationships and action. Proficiency in MS-Office and technically adept to other software packages as may be applicable for the position A match for Thermo Fisher core values - Integrity, Intensity, Involvement and Innovation
