Clinical Trial Manager

Encontrado em: Talent PT C2 - 2 semanas atrás

Lisbon, Portugal IQVIA Tempo inteiro

Join 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. CTMs contribute to delivery of pipeline through accurate planning and efficient execution of trials that bring speed & value to participating patients and sites.

The CTM provides leadership and direction to the R/OPU trial team for their responsible R/OPU and is accountable for the overall success and delivery of their assigned clinical trial/s according to defined milestones and key performance indicators (e.g. Medicine Excellence KPIs -MedEx). They are responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders (e.g. investigative sites) and trial team members at a regional/local and global level. 

The CTM is responsible for managing the planning, implementation, and tracking of the clinical trial process as well as risk mitigation. The CTM serves as a proactive member of the trial team, liaising closely with the Clinical Trial Leader (“CTL”) on all study-related issues. As leader of the R/OPU Trial Team, the CTM communicates trial status to stakeholders, escalating issues as appropriate. 

Essential Functions

Ensure the trial is conducted in compliance with GCP-ICH, local/global regulations, applicable SOPs and according to the trial protocol by overseeing CRO and internal team activities.

Creation, management and review of the R/OPU trial budget to ensure appropriate level of financial oversight and planning accuracy. Timely budget updates based on trial changes.

Appropriate trial-specific training of R/OPU internal and external partners is performed in line with Trial Training Plan.

Accurate planning and co-ordination of operational feasibility of trial timelines for their R/OPU; and oversight of trial preparation to ensure trial team members are aligned and on track. 

Verifies and provides input into the country and site level feasibility and OPU commitment (site and patient commitment). Finalize and validate site selection using available data sources and local insights/expertise, in collaboration with other functions (i.e. Medical Affairs, vendors if applicable). 

Development and implementation of country level engagement plans, recruitment planning and risk mitigation. Co-ordinates development of country level patient facing documents in close collaboration with relevant internal and external stakeholders. Reports patient and site level feedback as strategic insight to contribute to improving trial design with a focus on patient value

Frontloading of activities where possible at the R/OPU level to facilitate efficiencies as well as to ensure and leverage speed.

Oversees outsourcing of vendor services in the R/OPU in accordance to operating models and governance. 

Ensure timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders.

Qualifications

Bachelor's Degree Life sciences or related field Req Requires greater than 7 years clinical research experience including 4 years project management experience or equivalent combination of education, training and experience. Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.; Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge, therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.; Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills. Communication - Requires strong negotiation and customer management skills. Problem solving - Strong problem solving skills. Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.; Organisation - Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.; Leadership - Ability to make decisions, bringing clarity to disparate information to inform actions and drive results. Prioritisation - Ability to handle conflicting priorities. Ability to work strategically to realize project goals, identifying and developing positive and compelling visions for the successful delivery of the project. Quality - Attention to detail and accuracy in work. Quality - Results-oriented approach to work delivery and output. Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving. IT skills - Good software and computer skills, including MS. Office applications including but not limited to Microsoft Word, Excel and PowerPoint. Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients. Excellent customer service skills and demonstrated ability to understand customer needs. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues. Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences. Good understanding of other IQVIA functions and their inter-relationship with Project Leadership. Finances - Good understanding of project financials including experience managing, contractual obligations and implications. IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

What we offer

Focus on quality, not quantity We invest in keeping our teams stable, so workload is consistent. The chance to work on cutting edge medicines right at the forefront of drug development. Genuine career development opportunities for those who want to grow as part of the organization. Flexible conditions and an attractive remuneration package. Home-based roles in Portugal, Belgium, Nordics or Greece 

We invite you to join IQVIA™

Recognized by Great Place to Work as the second best company to work for (March 2019) FORTUNE Magazine's World's Most Admired Companies list for the third year in a row (January 2021) Recognized by the 2016 Scrip Awards as the Best Full-service Provider Contract Research Organization (CRO) Awarded the 2016 Eagle Award from the Society for Clinical Research Sites (SCRS) for the fourth consecutive year. A site-nominated award recognizing contract research organizations (CRO) and biopharmaceutical sponsors dedicated to building positive relationships with research sites through leadership, professionalism and integrity . IQVIA™ named in The International Association of Outsourcing Professionals (IAOP) 2017 Global Outsourcing 100® List which recognizes the world’s best service providers across a range of industries.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us . You will have the opportunity to play an important part in helping our clients drive healthcare forward and whatever your career goals, we are here to ensure you get there

Are you interested or do you know the ideal candidate?

If you know the right candidate or for more information on this role please contact Please note is necessary that your application is registered in our Talent Network (WorkDay) to process your candidacy

IQVIA 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

  • Associate Manager, Clinical Trials Regulatory Management- Home-based, Europe

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal IQVIA Tempo inteiro

    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...

  • Regulatory Manager, Clinical Trials Regulatory Management- Home-based, Europe

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal IQVIA Tempo inteiro

    Prepares 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...

  • Client Services Lead, Clinical Trial Payments

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal IQVIA Tempo inteiro

    Join 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 Data Manager

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal Fortrea Tempo inteiro

    As 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...

  • Site Solutions Analyst, Clinical Trial Payments

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal IQVIA Tempo inteiro

    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 human ingenuity to drive healthcare...

  • Manager, Clinical Data Management

    Encontrado em: Talent PT C2 - Há 7 dias

    Lisbon, Portugal IQVIA Tempo inteiro

    Job 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.  ...

  • Sr Site Enablement Solutions Project Lead

    Encontrado em: Talent PT C2 - Há 5 dias

    Lisbon, Portugal IQVIA Tempo inteiro

    Role 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...

  • Senior Statistical SAS Programmer, Oncology, Single Sponsor

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal Fortrea Tempo inteiro

    As 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...

  • Associate Client Services Lead

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal IQVIA Tempo inteiro

    Job 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...

  • Senior Clinical Research Associate

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal IQVIA Tempo inteiro

    Senior 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...

  • Medical Device

    Encontrado em: Talent PT C2 - Há 5 dias

    Lisbon, Portugal DNV Tempo inteiro

    DNV Product Assurance AS is one of the leading Notified Bodies for medical devices. Unit is entitled to carry out tasks related to conformity assessment of medical devices with EU Medical Devices Regulation before such products are placed on the market. The role of Internal Clinician is to assess clinical data supporting safety and performance of devices ...

  • VP, Medical

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal IQVIA Tempo inteiro

    Job Overview The Vice President Medical Strategy and Head of the Hematology/Oncology COE provides strategic medical and scientific leadership, subject matter experience and expertise to IQVIA and to IQVIA’s clients in Hematology and Oncology. The overarching remit is to grow IQVIA’s market share in hematology and oncology and will develop strategies...

  • Assoc Dir, Data Mgmt Connected Devices

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal IQVIA Tempo inteiro

    Job Overview This position is responsible for providing line management to an assigned data management team. This role is also responsible for delivering strategic solutions and process improvements for clients. Essential Functions Providing leadership of clinical data management activities across one or more programs enabling planning,...

  • Manager – R&D Transformation Consulting

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal IQVIA Tempo inteiro

    Overview IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. The team The R&D Transformation...

  • Customer & Project Manager Entyvio North

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal Takeda Tempo inteiro

    Description Customer & Project Manager, GI Location: Porto & North of Portugal JOB FUNCTION: As Customer and Project Manager for the GI Business Unit in Portugal, you will be responsible for supporting the development of local strategic customer relationships and implementations of GI infield projects to grow Takeda´s business within...

  • Sales Administrator

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal IQVIA Tempo inteiro

    With approximately 70,000 employees in more than 100 countries, IQVIA is in a truly unique position to be able to support companies seeking to improve real-world patient outcomes and enhanced clinical trial outsourcing through treatment innovations, care provision and access. With a broad range of healthcare information, technology and service offerings,...

  • Information Security Program Manager

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal IQVIA Tempo inteiro

    Location: Poland or Portugal Role As Information Security Program Manager at IQVIA, you will play a critical role in safeguarding our digital assets, ensuring the confidentiality, integrity, and availability of sensitive information. You’ll lead manage security programs, and drive compliance with industry standards and regulations. You’ll govern...

  • Medical Device Assessors

    Encontrado em: Talent PT C2 - Há 5 dias

    Lisbon, Portugal DNV Tempo inteiro

    DNV is a global leader and innovator in inspection, verification, testing and certification services. Founded in 1864, DNV is recognized as the global benchmark in quality and integrity. We encourage new ideas, we welcome people who challenge the way we do things, and we will be 100% committed to helping you reach your full potential. DNV Product Assurance...

  • Medical Device Assessors

    Encontrado em: Talent PT C2 - Há 5 dias

    Lisbon, Portugal DNV Tempo inteiro

    DNV is a global leader and innovator in inspection, verification, testing and certification services. Founded in 1864, DNV is recognized as the global benchmark in quality and integrity. We encourage new ideas, we welcome people who challenge the way we do things, and we will be 100% committed to helping you reach your full potential. DNV Product Assurance...

  • Technical Project Manager

    Encontrado em: Talent PT C2 - 2 semanas atrás

    Lisbon, Portugal Vodafone Tempo inteiro

    What you’ll do To manage the implementation project rollout of Enterprise Solutions, Security domain, according to the time plan, solution design, quality, and the efficiency levels, as well as to inform periodically the Customer, to ensure that his expectations are met at transition to Vodafone. Provide technical project management, deliver the...