Thermo Fisher Scientific
Clinical Trial Medic (client-dedicated)
Thermo Fisher Scientific, Suwanee, Georgia, United States, 30174
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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.
Discover Impactful Work:
The Clinical Trial Medic will provide medical support and medical advice for clinical trials and safety evaluation to PPD client.
A day in the Life:
Supports Development Team strategy and deliverables. Provides input on scope, complexity and size, and influence the budget of all aspects of a clinical program. Provides continual critical evaluation of the development/termination strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development or modification of development plans or study designs that may have a significant impact on timelines or study efficiency.
Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to clinical development team involved in these activities and is accountable for the successful design and interpretation of clinical studies.
Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance.
Involved in communications with study site personnel as needed to support and address medical concerns or questions raised by study site personnel.
Education
MD, MB/BS or equivalent degree and strong medical knowledge
Shown research clinical experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia
Knowledge, Skills, Abilities
Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important
Is fluent in spoken and written English
Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
Shown understanding of regulatory guidelines for adverse event reporting
Strong communication & presentation skills and is a strong teammate
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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.
Discover Impactful Work:
The Clinical Trial Medic will provide medical support and medical advice for clinical trials and safety evaluation to PPD client.
A day in the Life:
Supports Development Team strategy and deliverables. Provides input on scope, complexity and size, and influence the budget of all aspects of a clinical program. Provides continual critical evaluation of the development/termination strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development or modification of development plans or study designs that may have a significant impact on timelines or study efficiency.
Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to clinical development team involved in these activities and is accountable for the successful design and interpretation of clinical studies.
Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance.
Involved in communications with study site personnel as needed to support and address medical concerns or questions raised by study site personnel.
Education
MD, MB/BS or equivalent degree and strong medical knowledge
Shown research clinical experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia
Knowledge, Skills, Abilities
Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important
Is fluent in spoken and written English
Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
Shown understanding of regulatory guidelines for adverse event reporting
Strong communication & presentation skills and is a strong teammate
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.