Associate Manager, Clinical Trials Regulatory Management- Home-based, Europe
Encontrado em: Talent PT C2 - 2 semanas atrás
Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects.
RESPONSIBILITIES
Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers. Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements. Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications with minimum support of senior staff May strategically plan and perform European centralized submissions and facilitate global submissions May provide support on regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs) Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met. Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA). Deliver regulatory training/presentations as required. May perform additional tasks as deemed appropriate by Line ManagerREQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good understanding of the regulations, directives and guidance supporting clinical Research and Development Demonstrates comprehensive regulatory/technical expertise Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach Strong ownership and oversight skills Demonstrated skills in chairing small meetings Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision Ability to establish and maintain effective working relationships with co-workers, managers and clients Strong software and computer skills, including MS Office applicationsMINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9+ years’ experience* (*or combination of education, training and experience)PHYSICAL REQUIREMENTS
Extensive use of telephone and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time Travel might be requiredIQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
-
Regulatory Manager, Clinical Trials Regulatory Management- Home-based, Europe
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroPrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...
-
Clinical Trial Manager
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroJoin us in our exciting journey!! IQVIA is expanding in EMEA!! We currently have a Regional CPM to work sponsor-dedicated to one of our pharmaceutical clients The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the regional/local level....
-
Senior Clinical Data Manager
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal Fortrea Tempo inteiroAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Client Services Lead, Clinical Trial Payments
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroJoin us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, Technology, analytics and...
-
Senior Clinical Research Associate
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroSenior Clinical Research Associate IQVIA is the Human Data Science Company oriented to drive human health outcomes forward. When you join IQVIA Portugal as a sponsor-dedicated CRA, you’ll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. With access to...
-
Site Solutions Analyst, Clinical Trial Payments
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroIQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, Technology, analytics and human ingenuity to drive healthcare...
-
Senior Statistical SAS Programmer, Oncology, Single Sponsor
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal Fortrea Tempo inteiroAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Manager, Clinical Data Management
Encontrado em: Talent PT C2 - Há 7 dias
Lisbon, Portugal IQVIA Tempo inteiroJob Responsibilities Provide line and functional management of Data Management technical experts, with a team size of around 15-20 people. Manage and prioritize resource assignments, as well as workload management across Technical Design and SAS Programming teams ensuring project milestones are met according to agreed timelines with high quality. ...
-
Regulatory Affairs Manager
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroThe Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and execution.• Provide...
-
Associate Client Services Lead
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroJob Description The Associate Client Services Lead , under the supervision of senior members of Client Services team, serves as the main point of contact for their respective region's portfolio studies, manages the client / IQVIA PL relationship (as appropriate), oversee payment management projects and ensure sponsor satisfaction is achieved. Manage...
-
Sr Site Enablement Solutions Project Lead
Encontrado em: Talent PT C2 - Há 5 dias
Lisbon, Portugal IQVIA Tempo inteiroRole Overview: The Site Enablement Solutions team at IQVIA provides qualified, clinically experienced research staff to clinical trial sites globally to accelerate and optimize the performance of clinical trials. By supplying sites with support for data entry, patient recruitment, patient visits, assessments, and other tasks, IQVIA is able to relieve the...
-
Regulatory Compliance Project Manager
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal SGS Tempo inteiroJob Description We are looking for an experienced Regulatory Compliance product manager to join SGS DIGICOMPLY in Chiasso and lead our clients onboardings, Regulatory and food safety project implementations and renewals. This role is fundamental in ensuring that customers are getting the most out of the SGS Digicomply platform. You'll play a key role to...
-
Senior Manager, Commercial Strategy
Encontrado em: Talent PT C2 - Há 6 dias
Lisbon, Portugal Coca Cola Tempo inteiroDescription Summary: Job Title: Senior Manager Commercial Strategy - Europe Reports to: Senior RGM Director (Europe lead) Location: Europe flexible Thiscriticalrolefor the Companywill support the design and implementation of integratedRevenue Growth Management(RGM)approaches and plans todrivetopline revenue growth and margin expansionwith...
-
Associate Director/Associate Principal Scientist
Encontrado em: beBee S PT - 3 semanas atrás
Lisbon, Portugal Organon Tempo inteiroJob DescriptionThe PositionReporting to the Chemistry Manufacturing & Controls (CMC) Senior Principal Scientist, International CMC (EU/EEMEA), the successful Associate Principal Scientist will be accountable for assessment of changes for regulatory impact, development of regional CMC strategy in EU/EEMEA, preparation of CMC documentation and execution of...
-
Senior Regulatory Science and Strategy Lead
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal IQVIA Tempo inteiroOverview Individuals joining us are assured of a rewarding and progressive career in life sciences consulting. You’ll have the opportunity to address challenging client issues, across multiple geographies with a hands-on influence in delivering solutions. We operate in a truly multi-cultural, collegial and collaborative work environment that is rich in...
-
Direct Care Associate
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal State of North Dakota Tempo inteiroRSR Human Service Zone partners with the Department of Health and Human Services to deliver exceptional human service programs to our community. RSR is seeking a Direct Care Associate(39-37-5871) to join our team. This position will be based out of the Lisbon area. As a Direct Care Associate, you will provide in-home care, transportation, shopping, and...
-
University Recruitment Associate Manager
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal Indie Campers Tempo inteiroTHE ROLE As Indie Campers University Recruitment Associate Manager, you will be responsible for driving the strategy and execution of campus recruitment efforts and the execution of various internship early-career programs across Europe and México. You will be joining our People team in our Lisbon HQ, reporting directly to the Talent Acquisition...
-
Regulatory Business Analyst – DORA Implementation
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal Taleo Consulting Tempo inteiroMission. Our banking client is on the lookout for an experienced Regulatory Business Analyst to join our dynamic team. This role will play a crucial part in the implementation of the Digital Operational Resilience Act (DORA) , covering all six pillars of the program. What will you do? Act as a Business Analyst supporting the 6 pillars within...
-
Brand Manager
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal ambi.careers Tempo inteiro(We are supporting our client, OSCAR, to find a great Brand Manager in Lisbon. Check it out)The company:OSCAR is an on-demand home services app, offering over 150 fixed-price tasks such as repair, cleaning, and laundry, within a 30-minute reach. We're embarking on an exciting journey of international expansion to become one Europe's top players in the home...
-
Management Consultant
Encontrado em: Talent PT C2 - 2 semanas atrás
Lisbon, Portugal Efficio Tempo inteiroDescription Efficio's Managers/Senior Managers lead our engagements with clients. They have overall responsibility for ensuring that the objectives of the engagement are achieved, and client expectations are met. These Managers/Senior Managers set the strategic direction for the engagement and work with Consultants and other team members to ensure each...