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: Provides clear medical leadership in the Study team, working in close collaboration with the other members of this cross functional team, in order to provide reliable, high quality study data within time and budget.
A day in the Life: Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information, contribute to site selection, review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials. Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early. Pro-active escalation and correction of issues in consultation with the Global Medical Indication Lead. Interpret the clinical trial data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required, in consultation with the Indication Lead. Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications. Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP. Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties. In case more than 1 physician is working on the protocol, a primus inter pares will be appointed and he/she will ensure that answers to questions from sites/IRBs RAs, eligibility and protocol deviation decisions will be harmonised across medics. Education and background: Medical Doctor; relevant specialty education preferred (e.g. neurology, hematology, dermatology, immunology, rheumatology, internal medicine, pediatric). Some experience in industry preferred. Excellent English, both written and spoken is a must, as well as ability to travel. Proven interpersonal skills enabling to lead a study team, while recognising individual expert competencies, providing medical advice and evaluations exercising judgement in which issues need to be escalated immediately. Pro-active problem solver with negotiation skills, remaining sensitive to the different cultural needs in a global organisation. Strong communication skills to ensure close collaboration with the cross functional team members so that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties. 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.
#J-18808-Ljbffr
