Job Description:
Thermo Fisher Scientific offers rewarding jobs with a positive global impact. Together, let's accomplish our mission of empowering our clients to improve the security, hygiene, and well-being of the earth. By performing innovative research, creating novel treatments, and providing our staff with the resources they need to support each other in achieving their career goals, we advance science. With clinical trials conducted in over 100 countries, we provide laboratory, digital, and decentralized clinical trial services. Additionally, our PPD clinical research portfolio continuously develops novel frameworks for clinical research. It will be to the benefit of people and communities that depend on better health outcomes going forward that you are dedicated to delivering quality and accuracy.
Discover impactful work:
This function provides tactical oversight and strategic direction for the clinical and medical components throughout the whole clinical drug development process. This person is in charge of creating, devising, and implementing clinical development plans (CDPs), clinical trials, and procedures in accordance with applicable GCP criteria. This person is in charge of and takes part in the documentation of study outcomes, analysis of study data, and assessment of how successfully the study or studies have achieved regulatory or therapeutic objectives. This person may represent the clinical or medical community in meetings with partners (i.e., vendors, consultants, etc.), external audiences, and external stakeholders (i.e., collaborators, Key Opinion Leaders (KOLs), investigators, regulatory authorities, etc.). Within the neurological field, there are currently internal PPD roles that are client-dedicated.
A day in the life:
Manages the clinical research and provides medical information. Health care clinical research observation. Provide and authorize the scientific methods that direct the development and implementation of clinical protocols. Ensure the security of research participants. Regularly review lab, adverse event, and other clinical data, and ensure that reporting is finished on time. Collaborate with the study executive and the independent safety committee as needed. Take part in study teams as a clinical researcher representative. As needed to carry out clinical studies, participates in the creation, evaluation, and approval of study protocols, protocol modifications, study manuals, investigator brochures (IBs), clinical study reports (CSRs), informed consent forms (ICFs), case report forms (CRFs), and other clinical documentation. It summarizes, interprets, and records clinical data for publications, articles, and regulatory filings (INDs, annual reports, NDAs, MAAs, etc.) as needed. Collaborate with premier academic health facilities. Locate, guide, and motivate clinical investigators. To ensure study compliance, adhere to all relevant SOPs and GCPs. Take part in strategic long-term planning. Instruction It is necessary to have a medical degree with a specialty in neurology. experience in the field of neurology drug development. It is preferred if you have knowledge of translational medicine or monoclonal antibodies.
Know-How, Proficiency, and Abilities:
demonstrating an excellent capacity for leadership and a conscientious and proactive attitude to problem solving. They can provide multiple examples of how to build and use the scientific and clinical principles required to prepare the protocols for clinical trials and investigations. shown expertise in the design, implementation, and evaluation of clinical trials. prior expertise submitting to regulators. exceptional communication skills both in writing and speaking. the capacity to travel. Enabling our clients to make a positive, healthier, and more clean world is our mission. Check out the five justifications our colleagues give for working with us. Our team of over 100,000 colleagues is driven by integrity, passion, invention, and involvement. We work together to solve challenging scientific challenges, accelerate technological innovation, help patients in need, and speed up research. PPD, a Thermo Fisher Scientific division, is a place where you may #BeginYourStory and where a variety of perspectives, experiences, and backgrounds are valued.
Apply today! thermofisher.com jobs Thermo Fisher Scientific is an Equal Employment Opportunity/Affirmative Action Employer and does not discriminate on the basis of any legally protected status, including national origin, race, color, religion, sex, sexual orientation, gender identity, handicap, or any other basis.
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