ph3Work Schedule /h3 pStandard (Mon-Fri) /p h3Environmental Conditions /h3 pOffice /p h3Job Description /h3 pAt 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. /p pManages, coordinates and evaluates medical projects for one or more programs in collaboration with management and other stakeholders to ensure consistency, alignment, and compliance of internal processes as well as optimal performance and issue resolution throughout project lifecycle. Represents the company in the medical research community and develops collaborative relationships with client company personnel. /p h3Essential Functions: /h3 ul lipWorks independently to perform first pass review of safety data, utilizing line listings, company dashboard(s) and/or other visualization tools. Reviews data for safety trends, coding consistencies, and potential follow up with investigator sites. Proactively identifies any potential issues and resolves or escalates as appropriate. /p /li lipReviews safety data and provides summations for safety review meetings. /p /li lipReviews designated sections of aggregate reports. /p /li lipIndependently functions as the Project Lead for medical monitoring services when SAE case processing has not been contracted. Manages project implementation, coordination, maintenance and close out of assigned studies as applicable.



Serves as the primary point of contact for clinical project teams on studies and can act as the alliance level lead on larger alliance/multi-protocol studies. /p /li lipCreates and maintains medical management plan(s) on studies (as applicable) and ensures that the processes included in the plan document are reflective of the contract and services requested for studies that have department involvement and those that are standalone studies (ex. MM and/or MPC). /p /li lipWorks independently to monitor the project financial status, unit forecasting, actual realization, and team allocations in systems. Coordinates staff projections based on contract values and actual hours used. Escalates any financial and/or operational risks and can attend risk management meetings to discuss. /p /li lipIndependently determines hours required for out of scope work for the teams and provides this to the finance/study team for contract modifications. Attends meetings to discuss/justify the modification requirements. /p /li lipResolves complex problems through in-depth evaluation of various factors and offers solutions. May assist management in training and mentoring. /p /li lipPresents at business development, client, and investigator meetings and participates in strategy/business development calls. Represents studies at risk management meetings. /p /li /ul h3Qualifications: /h3 h3Education and Experience: /h3 ul lipBachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN /p /li lipPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years), to include 5+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance) /p /li /ul pIn some cases an equivalency,



consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. /p h3Knowledge, Skills and Abilities: /h3 ul lipAdvanced knowledge of GCPs for medical oversight of clinical trials /p /li lipKnowledge of drug development and safety reporting /p /li lipAdvanced knowledge of safety data trending to include coding /p /li lipWorking knowledge of biostatistics, data management and clinical procedures /p /li lipExcellent problem solving and critical thinking skills /p /li lipExcellent project management and budget skills /p /li lipEffective mentoring skills and ability to train and lead others /p /li lipStrong oral and written communication skills /p /li lipStrong attention to detail /p /li lipAbility to work in a collaborative team environment /p /li lipAbility to maintain a positive and professional demeanor in challenging circumstances /p /li /ul pOur 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. /p pThermo 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. /p pThermo 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. /p /p #J-18808-Ljbffr

📌 Senior Medical Project Coordinator, EMEA (Roma)
🏢 Thermofisher Scientific
📍 Roma