About the Job

Excelya is looking for an experienced eCOA Lead Senior to join our innovative team! In this pivotal role, you will take the lead in managing electronic Clinical Outcome Assessments (eCOA) across clinical trials, ensuring that data collection meets the highest standards of quality, efficiency, and regulatory compliance.

As an eCOA expert, you will work collaboratively with various stakeholders to develop and implement strategies that enhance the clinical study experience for participants and investigators alike.

Main Responsibilities

• Lead the design, implementation, and management of eCOA solutions for clinical trials.
• Work closely with clinical project teams to deliver eCOA requirements aligned with objectives and timelines.
• Coordinate the development and maintenance of eCOA systems, ensuring compliance with relevant regulatory frameworks.
• Provide training and support to study teams on eCOA processes and tools.
• Monitor eCOA data quality and provide insights for continuous improvement.
• Collaborate with IT and third-party vendors to optimize eCOA technology and interfaces.

Requirements

About You

We are looking for a passionate individual who shares our values of audacity, care, and energy!

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Data Management. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

The Clinical Data Manager is responsible for performing Data Management tasks per client work orders to high regulatory standards and Excelya Group SOPs. 

Main Responsibilities

·       Deeply acknowledges and strictly follows Excelya and Client’s SOPs, guidelines and appropriate local and international legislation.

·       CDMI works under the supervision of more senior staff (Manager or Senior CDM).

·       Responsible for data cleaning, data review, discrepancy management and data reconciliation activities on the studies assigned to him/her.

·       Work closely with the Lead Data Manager responsible for the study.

·       Generate study metrics and status reports within and across several studies. 

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team. You will play a critical part in driving innovatio and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Activities

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team. You will play a critical part in driving innovatio and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Activities

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team. You will play a critical part in driving innovatio and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Activities

Excelya is seeking a Statistical Programmer to join our innovative team dedicated to advancing clinical research. We pride ourselves on our core values of Audacity, Care, and Energy, and we believe that your expertise can help us make a significant impact in the healthcare domain.

As a Statistical Programmer, you will play a critical role in processing and analyzing clinical trial data. Utilizing your programming skills, you will ensure the accuracy and integrity of statistical outputs, contributing to the development of high-quality study reports.

Key Responsibilities:

• Develop, validate, and maintain SAS programs for clinical data analysis and reporting.
• Generate statistical tables, listings, and graphics in accordance with study specifications.
• Collaborate with biostatisticians and data management teams to clarify deliverables and timelines.
• Conduct quality control checks on programming outputs to ensure data consistency and compliance with regulatory standards.
• Provide documentation and support for all programming activities, including maintaining version control.
• Assist in the preparation of statistical analysis plans and regulatory submissions as needed.

Requirements

Qualifications

About the Job

Excelya is looking for a dedicated Data Analyst R&D to join our dynamic Research and Development team. In this role, you will play an essential part in transforming complex data into actionable insights that drive our innovative projects and strategies.

As a Data Analyst, you will collaborate with cross-functional teams to analyze and interpret data from clinical trials, enabling informed decision-making and advancing our mission to improve patient outcomes.

Main Responsibilities:

• Create data visualization solutions.
• Define, specify, build, and/or improve:
• Data structures necessary for storage and analysis: core models, business views, and ad hoc tables (in DBT).
• Reports, dashboards, and data visualizations.
• Unit tests and validation on data preparation, reports, and dashboards.

Deliverables:

• Data preparation: core models, business views, and ad hoc tables (specifications + development and feeding of structures).
• Data analysis and visualization: Data Report, Dashboard, Scoring board, etc.
• Validation reports.

Requirements

About You

We are looking for passionate individuals who thrive in a collaborative environment and are eager to contribute to impactful projects.

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. As a Clinical Research Associate at Excelya, you will be responsible for overseeing the progress of clinical trials, ensuring compliance with regulatory requirements, and supporting site staff in their efforts to conduct research that improves patient outcomes.

Main Responsibilities:

• Conduct site initiation visits, monitoring visits, and close-out visits.
• Ensure site compliance with study protocols, ICH-GCP guidelines, and applicable regulations.
• Communicate effectively with study sites to facilitate the trial process and address any issues that arise.
• Review and verify study-related documents and data for accuracy and completeness.
• Monitor patient safety and data integrity throughout the study.
• Assist in preparing for audits and regulatory inspections.
• Provide regular updates to project managers and stakeholders about site progress and challenges.

Requirements

About You:

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Safety. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main responsibilities :

• Manage end to end process for clinical site contracts and clinical trial related consulting agreements (including contracts, amendments and termination letters preparation, negotiation, escalation, translation, distribution, signature, archiving).

• Support site-related questions regarding invoice preparation with respect to submission of invoices in Amgen Payment System (eGPS)

• Support resolution of contract issues

• Support contracting with local GSO vendors

• Maintain contract tracking in appropriate systems

• Manage Confidential Disclosure Agreement process

• Identify opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness

• Ensure payments are made in accordance with contracts

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities