Regulatory Compliance Specialist for Clinical Research
Há 1 mês
We are seeking an experienced Regulatory Compliance Specialist for Clinical Research to join our team at Ppd Latin America. As a key member of our operations, you will be responsible for ensuring the efficient delivery of contracts and managing local regulatory submissions in accordance with global submission strategy.
About the Role- Prepare, review, and coordinate local regulatory submissions (MoH, EC, special national local applications) under guidance;
- Draft, review, negotiate, and finalize agreements with study sites according to local/accepted process;
- Negotiate within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company, client, and established process;
- Evaluate legal, financial, and operational risks and escalate to appropriate level per established processes;
- Provide recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channels;
- Coordinate with internal functional departments to ensure site startup activities align with contractual activities and mutually agreed timelines;
To succeed in this role, you will need:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification;
- Previous experience providing knowledge, skills, and abilities comparable to 2-5 years;
- Good understanding of contract law principles and laws influencing contract language;
- Demonstrated ability to apply basic principles of investigator grant negotiation;
- Effective communication skills (verbal & written) in English and local language;
- Able to work independently or in a team environment with good organizational and time management skills.
As a valued member of our team, you can expect:
- A competitive salary range of $80,000 - $120,000 per year, depending on experience;
- An extensive benefits package focused on employee health and well-being;
- A flexible working culture that prioritizes work-life balance;
- Opportunities for professional growth and development through our award-winning learning program.
-
Clinical Nurse Specialist for Clinical Trials
4 semanas atrás
Lisboa, Lisboa, Portugal Icon Plc Tempo inteiroWe are seeking a highly skilled Clinical Nurse Specialist to join our team at ICON Plc. This role is based in Ireland, with opportunities to work from home or the office.About ICON Plc:ICON Plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence.This...
-
Global Clinical Trials Regulatory Specialist
3 semanas atrás
Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiroThermo Fisher Scientific, a leading global biotechnology company, is seeking an experienced Regulatory Affairs Specialist to join our Global Clinical Trial team. With a competitive salary of $120,000 per annum, this role offers a unique opportunity to contribute to the development and implementation of regulatory strategies for clinical trials...
-
Senior Clinical Research Associate
4 semanas atrás
Lisboa, Lisboa, Portugal Iqvia Argentina Tempo inteiroAbout IQVIA PortugalIQVIA is a leading global contract research organization driving human health outcomes forward.As a sponsor-dedicated CRA, you will enjoy the stability and resources of a global company while gaining direct experience with one of our customers. With access to world-class training and mentoring, you will have the opportunity to put your...
-
Senior Clinical Data Analyst
2 semanas atrás
Lisboa, Lisboa, Portugal Icon Clinical Research Tempo inteiroDiscover the opportunity to excel in a world-leading healthcare intelligence and clinical research organization. ICON plc is dedicated to fostering an inclusive environment that drives innovation and excellence, and we invite you to be part of our mission to shape the future of clinical development.About UsWe're looking for a talented Senior Clinical Data...
-
Clinical Research Associate
4 semanas atrás
Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiroTransforming Lives Through Clinical ResearchAt Thermo Fisher Scientific, we're committed to making a positive impact on a global scale. Our mission is to enable our customers to create life-changing therapies and improve health outcomes for people and communities worldwide.We're seeking a talented Clinical Research Associate to join our team in Portugal. As...
-
Senior Data Analyst for Pharmaceutical Research
4 semanas atrás
Lisboa, Lisboa, Portugal Icon Clinical Research Tempo inteiroAbout ICON Clinical ResearchICON plc is a leading healthcare intelligence and clinical research organization. We foster an inclusive environment driving innovation and excellence, with a mission to shape the future of clinical development.The RoleWe are seeking a highly skilled Statistical Programmer II to join our team in Lisbon, Portugal. As a key member...
-
Clinical Research Associate
4 semanas atrás
Lisboa, Lisboa, Portugal IQVIA Tempo inteiroAbout the RoleWe are seeking a highly skilled Clinical Research Associate to join our team at IQVIA Portugal. As a key member of our sponsor-dedicated CRA team, you will have the opportunity to work on a wide variety of therapeutic areas and gain direct experience with one of our customers.ResponsibilitiesPerform site selection, initiation, monitoring, and...
-
Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiroAbout the RoleWe are seeking a Clinical Trial Regulatory Affairs Specialist to join our global Regulatory Affairs department – Regulatory Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.Job DescriptionIn this role, you will be a pivotal team member with regulatory...
-
Regulatory Compliance Expert
4 semanas atrás
Lisboa, Lisboa, Portugal Sovos Compliance Tempo inteiroWelcome to Sovos Compliance, a global leader in tax compliance solutions. We're seeking an experienced Regulatory Compliance Expert to join our team.At Sovos Compliance, we're dedicated to helping businesses navigate the ever-changing regulatory landscape and transform tax compliance from a business requirement to a force for growth.This is an exciting...
-
Clinical Monitoring Specialist
3 semanas atrás
Lisboa, Lisboa, Portugal Phiture Tempo inteiroJob Description:We are seeking a highly motivated Clinical Monitoring Specialist to join our team in Clinical Research. As a key member of our team, you will be responsible for ensuring the integrity and quality of clinical trials by conducting site monitoring responsibilities according to our Standard Operating Procedures (SOPs), ICH guidelines, and GCP.Key...
-
Clinical Development Specialist
4 semanas atrás
Lisboa, Lisboa, Portugal 492 GlaxoSmithKline - Produtos Farmaceuticos, Limitada Tempo inteiroOverviewGSK is a global biopharma company dedicated to uniting science, technology, and talent to get ahead of disease together.SalaryEstimated salary: R$ 12.000,00 per month (approximate base salary in Brazil). Compensation package may vary based on location and other factors.About the RoleThis role will involve key responsibilities:Tender Specialist:...
-
Senior Clinical Trials Nurse Specialist
4 semanas atrás
Lisboa, Lisboa, Portugal Icon Plc Tempo inteiroClinical trials play a crucial role in advancing healthcare and improving patient outcomes. ICON plc is a leading organization that empowers innovation and excellence in clinical development.We are currently seeking a Senior Clinical Trials Nurse Specialist to join our dynamic team. This key role will involve collaborating with clinicians, assessing patient...
-
Regulatory Compliance Specialist
4 semanas atrás
Lisboa, Lisboa, Portugal Inetum Tempo inteiroJob OverviewWe are seeking a skilled Regulatory Compliance Specialist to join our Inetum team in Lisbon. This role involves working with clients to ensure compliance with regulatory requirements.
-
Clinical Trial Coordinator for Study Execution and Compliance
2 semanas atrás
Lisboa, Lisboa, Portugal Iqvia Argentina Tempo inteiroAbout the RoleClinical Trial Administrators at Iqvia Argentina play a vital role in ensuring the success of our clinical trials. As a Sr Clinical Trial Assistant/Start-Up, you will be responsible for coordinating and administering daily administrative activities to ensure a complete and accurate Trial Master File delivery.Key Responsibilities:Assist Clinical...
-
Regulatory Compliance Specialist
1 dia atrás
Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiroLocated in the heart of Ebury's Lisbon office, our Regulatory Compliance Specialist will play a pivotal role in maintaining the integrity and compliance of our Portuguese branch. Reporting directly to our EEA MLRO, this individual will be responsible for ensuring adherence to regulatory requirements, reporting obligations, and fostering effective...
-
Clinical Trial Activation Specialist
Há 1 mês
Lisboa, Lisboa, Portugal Icon Tempo inteiroJob SummaryWe are seeking a skilled Clinical Trial Activation Specialist to join our team at ICON. As a Site Activation Lead, you will be responsible for advancing clinical trial start-up activities by understanding client objectives and assisting in the development of plans for country and site distribution.About ICONICON plc is a world-leading healthcare...
-
Regulatory Compliance Liaison Specialist
4 semanas atrás
Lisboa, Lisboa, Portugal Cross Border Talents Tempo inteiroJob OverviewThis role is an opportunity to work with Cross Border Talents in ensuring the compliance of transport operators with passenger rights regulations. As a Regulatory Compliance Liaison Specialist, you will be responsible for collaborating with legal professionals and regulatory bodies to resolve passenger rights issues.
-
Clinical Research Coordinator
4 semanas atrás
Lisboa, Lisboa, Portugal Iqvia Argentina Tempo inteiroJob OverviewClinical Trial Administrators play a vital role in ensuring the successful execution of clinical trials. As a Clinical Trial Assistant, you will be responsible for performing daily administrative activities in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams.Key Responsibilities:Assist in coordinating and...
-
Clinical Research Associate I
Há 1 mês
Lisboa, Lisboa, Portugal Syneos Health, Inc. Tempo inteiroJob ResponsibilitiesAs a Senior Clinical Research Associate I at Syneos Health, Inc., you will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits, ensuring regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) compliance. You will use your judgment and experience to...
-
Regulatory Compliance Specialist
4 semanas atrás
Lisboa, Lisboa, Portugal Cross Border Talents Tempo inteiroAbout Cross Border Talents: At Cross Border Talents, we are passionate about connecting talented individuals with exciting career opportunities in the industry. Our company culture emphasizes collaboration, innovation, and mutual respect.Job Overview: We are currently seeking a highly skilled Regulatory Compliance Specialist to join our team. In this role,...