Job Title: Senior Medical Monitor

Location: EU/Non EU

Type: Remote, Freelance

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 Medical Affairs. 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:

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 Pharmacovigilance. 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:

• Supervise pharmacovigilance case management outsourced to assigned platform(s)
• Respond to case-related emails and inquiries from external service providers
• Monitor case processing timelines and investigate any delays in reporting or transmission
• Participate in weekly quality control of data entry, MedDRA coding, and narrative writing
• Support the review and validation of clinical study case narratives for inclusion in study reports
• Contribute to the reconciliation of PV cases with business partners per Safety Data Exchange Agreements (SDEAs)
• Oversee reconciliation of cases with clinical databases managed by outsourced providers
• Collaborate closely with cross-functional and global teams to ensure compliance and data integrity

Requirements

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.

As an external Global Evidence Generation manager, you will be responsible for the international management of several clinical studies (prospective Phase IV and / or epidemiological or retrospective studies) including Real World Evidence studies. You will contribute to the design of new projects defined portfolio strategy as well as the impactful communication of key results. The role requires a strong background in international and local study management, including the management of global Clinical Research Organizations, central medical review, statistical interpretation.

Main Responsibilities:

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!