Sr. Clinical Trial Manager
2 giorni fa
Sr.Clinical Trial Manager (Clinical Research Medical Advisor) – FSP – Homebased – ItalyJoin to apply for theSr.Clinical Trial Manager (Clinical Research Medical Advisor) – FSP – Homebased – Italyrole atSyneos Health.Company OverviewSyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do.We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.We are agile and driven to accelerate the delivery of therapies because we are passionate to change lives.WORK HERE MATTERS EVERYWHEREWe are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to our Total Self culture – where you can authentically be yourself.Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.We are continuously building the company we all want to work for and our customers want to work with.Why?Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.Job ResponsibilitiesThe Sr.Clinical Trial Manager (Clinical Research Medical Advisor) is responsible for providing medical and scientific leadership to ensure the high-quality execution of clinical trials and studies in the assigned country or cluster.This role bridges Clinical Development and cross-functional teams, ensuring local medical input and compliance with regulatory standards.Key ResponsibilitiesLead local clinical/medical aspects of trial implementation, including protocol review, site selection support, feasibility assessments, and recruitment strategy planning.Act as the medical representative to support study design, regulatory interactions, and site training to ensure protocol adherence and patient safety.Identify pro-actively recruitment challenges or operational challenges and develop migration plans.Provide protocol/compound and indication trainings to internal and external partners.Provide medical input for Informed Consent Forms (ICFs) and safety reporting.Partner with clinical operations, regulatory, medical affairs, and external experts to optimize trial execution.Support safety oversight: review serious adverse events (SAEs), provide pharmacovigilance support, and ensure clinical data quality.Contribute to early trial start-up by validating study feasibility and supporting site engagement and training.Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and country regulations.Contribute to internal and external scientific discussions, including advisory boards and investigator meetings.Provide clinical/medical expertise for regulatory inspections, audits, and trial documentation.May work cross-country.QualificationsEducationMedical Doctor Degree is highly preferred.Pharma Degree or PhD would be also considered in case of proven experience as Medical Science Liaison/Advisor.LanguageFluent in Italian and English (speaking and writing).ExperienceMinimum 3 years in clinical development or clinical practice in the pharmaceutical or healthcare sector.Strong understanding of clinical trial design, implementation, and ICH/GCP principles.SkillsProven ability to analyze complex clinical/scientific issues and provide practical solutions.Strong communication and leadership skills to work cross-functionally.Problem-solving mindset and agility across therapeutic areas.Excellent presentation skills in English and local language.Technical CompetenceStrong protocol review and feasibility assessment skills.Understanding of safety and regulatory requirements in clinical trials.Experience supporting regulatory submissions, audits and inspections.Travel RequirementUp to 50% travel.Get to Know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.Learn more about Syneos Health.syneoshealth.comAdditional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive.The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.Further, nothing contained herein should be construed to create an employment contract.Occasionally, required skills/experiences for jobs are expressed in brief terms.Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.SummaryRoles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities.Collaborates with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plans logistics and resource usage.Tracks study progress in alignment with project milestones, client deliverables, and budget, and follows applicable regulations globally and by region.Impact and Contribution Includes executives as well as managers, supervisors and team leads providing strategic vision and/or tactical direction across a discipline and/or broader organization.The majority of time is spent overseeing their area of responsibility, planning, prioritizing, and/or directing the responsibilities of employees.Goal are achieved through management of process, policy, and performance of direct and/or indirect reports.Manages a team of individual contributors and/or Supervisors.Delivers operational results that have direct impact on immediate or short-term department results.In-depth knowledge and skills within a scientific/technology or professional discipline, understanding impact of work on related areas.Requires practical knowledge in managing the execution of processes, projects and tactics within team.Seniority LevelMid-Senior levelEmployment TypeFull-timeJob FunctionResearch, Analyst, and Information Technology#J-*****-Ljbffr
-
Clinical Project Manager
5 giorni fa
Bardi, Italia Epm Scientific A tempo pienoEPM Scientific are currently partnered with a Biotechnology company who are seeking a Freelance Clinical Project Manager to support their Rare Disease trials in Italy.Contract Conditions:ASAPContract: 0.8 - 1 FTE, 12-Month ContractProject: Lead and manage global Phase II-III clinical trials across Rare Disease indicationsOversee cross-functional teams...
-
Freelance Clinical Project Manager
1 settimana fa
Bardi, Italia Epm Scientific A tempo pienoEPM Scientific are currently partnered with a Biotechnology company who are seeking a Freelance Clinical Project Manager to support their Rare Disease trials in Italy.See a short summary below:Contract Conditions:Start date: ASAPLocation: ItalyContract: 0.8 - 1 FTE, 12-Month ContractProject: Rare Neuromusclar Disease - Phase 2 Trial Key ResponsibilitiesLead...
-
Freelance Clinical Project Manager
2 settimane fa
Bardi, Italia Epm Scientific A tempo pienoEPM Scientific are currently partnered with a Biotechnology company who are seeking aFreelance Clinical Project Managerto support their Rare Disease trials in Italy.See a short summary below:Contract Conditions:Start date: ASAPLocation: ItalyContract: 0.8 - 1 FTE, 12-Month ContractProject: Rare Neuromusclar Disease - Phase 2 TrialKey ResponsibilitiesLead and...
-
Clinical Study Administrator — Hybrid Etmf
5 giorni fa
Bardi, Italia Astrazeneca A tempo pienoA leading pharmaceutical company in Milan is seeking a Clinical Study Administrator to coordinate clinical trial activities, ensuring compliance with regulatory standards.The ideal candidate has a Bachelor's degree in a life science discipline, 2+ years of experience in clinical research, and strong organizational skills.This role supports trial operations...
-
Study Project Manager
3 giorni fa
Bardi, Italia Evidilya A tempo pienoEvidilya , the dedicated Contract Research Organization of Sprim Health Group operates as a full-service international expertise in successfully developing and managing observational, pre-clinical and clinical trials in the field of Food&Nutrition, Pharma and Medtech/Medical Devices industries with a strong technological and digital footprint, is looking for...
-
Clinical Research Physician
2 giorni fa
Bardi, Italia Medpace A tempo pienoWe are seeking Clinical Research Physicians to join our dynamic team.The Clinical Research Physician will have overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials.Additionally, this role acts as the Medpace internal medical expert and will serve as a...
-
Clinical Specialist
1 settimana fa
Bardi, Italia Bd A tempo pienoClinical Specialist (Biosurgery & Infection Prevention)Join to apply for theClinical Specialist (Biosurgery & Infection Prevention)role atBDJob Description SummaryThe Clinical Specialist provides comprehensive clinical and technical support to the sales team and customers across Italy for BIP solutions.Duties include training, operating-room activities,...
-
Impiegato/A Di Segreteria
1 settimana fa
Bardi, Italia Manpower Varese Business Professional (Hub) A tempo pienoAZIENDA SOCIO SANITARIA TERRITORIALE DEI SETTE LAGHIOperatori amministrativi per la S.C. Farmacia Comitato Etico e Clinical Trial CenterIl nostro clienteAZIENDA SOCIO SANITARIA TERRITORIALE DEI SETTE LAGHIci ha incaricati di ricercare Operatori amministrativi da dedicare alle attività del Comitato Etico e del Clinical Trial Center presso la sede di...
-
Senior Clinical Research Associate
7 giorni fa
Bardi, Italia Jr Italy A tempo pienoSocial network you want to login/join with:Senior Clinical Research Associate, cremonacol-narrow-leftClient:TeleflexLocation:Job Category:Other-EU work permit required:Yescol-narrow-rightJob Reference:8556790222002585600337134Job Views:2Posted:**********Expiry Date:**********col-wideJob Description:POSITION SUMMARY:The Senior Clinical Research Associate...
-
Clinical Research Associate
1 settimana fa
Bardi, Italia Ab Lavoro A tempo pienoSiamo una società di consulenza, specializzata nella ricerca e selezione del personale, autorizzata dal Ministero ad operare come Agenzia per il Lavoro (Aut. Min. Lav. n. 13/I/****), su tutto il territorio nazionale.Che tu voglia inserirti nel mondo del lavoro, o sia alla ricerca di nuovi stimoli professionali, AB Lavoro è pronta a supportarti per un nuovo...