Description of Roles and Responsibilities: This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Sponsor policies and procedures, …
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Full-time
Posted 1d ago
~40 hrs/week
Responsibilities
The Clinical Operations Manager is responsible for the performance, compliance, and financial oversight of assigned clinical trial protocols in Portugal. This includes managing site budgets, regulatory submissions, and coordinating with internal and external stakeholders to ensure study milestones are met.
Requirements
Candidates must have 5-7 years of experience in clinical research and be fluent in Portuguese. The role requires the ability to work on-site and effectively manage complex clinical trial operations and financial compliance.
Full job description
Description of Roles and Responsibilities:
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
Responsibilities include but are not limited to:
Ownership of country and site budgets. Development, negotiation, and completion of Clinical Trial Research Agreements (CTRA).
Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /CRDs, other roles. • Executes and oversees clinical trial country submissions and approvals for assigned protocols. • Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols. • Manages country deliverables, timelines, and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country. • Contributes to the development of local SOPs. Oversees CTCs as applicable. • Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. • Collaborates closely with Headquarter to align country timelines for assigned protocols. • Provides support and oversight to local vendors as applicable. • Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems. • Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. • Required to in/directly influence investigators, external partners and country operations to adheres to budget targets and agreed payment timelines. • Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value. • Contribute or lead initiatives and projects adding value to the business • Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required. • Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required
Experience Required:
5-7 years of experience in clinical research.
Portuguese fluent. • Office visits required for Face-to-Face meetings.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.
IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific progress, in an effort to advance healthcare. To learn more, visit www.iqvia.com.
Offices: 2400 Ellis Rd, Durham, North Carolina 27703, US
How many Science & Research jobs are open in Lisbon, Portugal right now?
There are currently 114 open science & research positions in Lisbon, Portugal listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Lisbon, Portugal?
Companies currently hiring include IQVIA, AniCura Portugal, CTI Clinical Trial and Consulting Services, Anyone App, AstraZeneca, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in Lisbon, Portugal?
Yes — 73 of the 114 open science & research positions offer remote or hybrid work (22 remote, 51 hybrid).
How do I apply for Science & Research jobs in Lisbon, Portugal?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.