We are seeking an experienced Clinical Project Manager to oversee and coordinate clinical activities in pharmaceutical environment.
The role involves managing operational aspects of clinical trials, ensuring compliance with regulatory requirements, and acting as the primary interface between local stakeholders, investigators, vendors, and global teams.

This position requires strong autonomy, rigor, and excellent communication skills, with the ability to navigate cross‑functional environments.

Key Responsibilities :

1. Study Management

• Lead and coordinate clinical trial activities at the local level from start‑up to close‑out.
• Ensure local execution of global study plans in alignment with timelines and quality standards.
• Serve as the key point of contact for local investigational sites and regional stakeholders.

2. Regulatory & Compliance Oversight

• Ensure that clinical trial activities comply with local regulations, ICH‑GCP, and internal SOPs.
• Coordinate local submissions to competent authorities and ethics committees when required.
• Monitor adherence to regulatory timelines and manage any corrective actions.

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.

We are seeking a Clinical Outcome Assessment (COA) Lead to drive COA strategy across innovative clinical development programs, ensuring the patient voice is integrated into clinical research and that meaningful outcomes are used to demonstrate the real impact of treatments on patients' lives.

Key Responsibilities:

• Define and lead the COA strategy across clinical development programs.
• Ensure the patient perspective is incorporated into study design and endpoint selection.
• Select, develop, and validate appropriate COA instruments (PROs, ClinROs, ObsROs, PerfOs).
• Provide scientific expertise on patient-centered outcomes and endpoint strategy.
• Collaborate cross-functionally with Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs, HEOR, and external vendors.
• Support regulatory submissions, publications, and scientific communications related to COA data.
• Oversee COA implementation and data quality throughout clinical studies.

Requirements

Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.Our global team of experts are the powerful force behind our success. When you work at Excelya, you become part of an international network that nurtures your talent, builds your skills and recognizes your value.

Our client is looking for a senior regulatory consultant to provide strategic and operational Regulatory CMC leadership support for a global Antibody-Drug Conjugate (ADC) biologics program. The selected consultant will play a critical role in leading global Regulatory CMC activities associated with Marketing Authorisation Applications (MAA) and/or Biologics License Applications (BLA), with a focus on global regulatory CMC strategy and matrix-management leadership.

Missions

Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.Our global team of experts are the powerful force behind our success. When you work at Excelya, you become part of an international network that nurtures your talent, builds your skills and recognizes your value.

The selected consultant will play a critical role in leading the global Regulatory CMC strategy for a small molecule product, with a particular focus on Module 3 preparation, Marketing Authorization Applications, global health authority interactions, and regulatory submission readiness

Missions

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

As part of our activities, we are looking for an experienced Senior Project Manager Clinical Systems to support one of our pharmaceutical partners in the framing and assessment of digital initiatives within Clinical Development.

Within the Clinical System Management department, you will support initiative sponsors during the Opportunity and Feasibility phases, prior to project implementation.

Key responsibilities :

• Clarify the business needs, objectives and expected value of new initiatives.
• Identify and map impacted business processes, systems and stakeholders.
• Lead workshops with Business, IT and senior stakeholders.
• Assess project feasibility, risks, dependencies and key success factors.
• Define required resources, budget estimates and governance.
• Develop high-level project roadmaps and recommendations.
• Deliver structured project framing and feasibility documentation to support decision-making.

Requirements

Education : Master’s degree or equivalent in Life Sciences, Engineering, Information Systems, Project Management, Business or a related field.

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

This role offers an exciting opportunity to support a strategic productivity initiative within a leading pharmaceutical R&D environment. As a Data Manager – Efficiency Engine, you will contribute to improving operational efficiency, optimizing data workflows, and implementing automation solutions to accelerate project delivery within Research and Translational Medicine activities.

Key Responsabilities :

About the Job

At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Senior CMC Regulatory Consultant specializing in small molecules lifecycle management to join our dynamic team.

This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to post-marketing activities. As a Senior Consultant, you will work closely with cross-functional teams to ensure robust regulatory strategies, compliance, and submission excellence.

The main objectives of this role are to lead the CMC Regulatory strategy of a small molecule asset (late phase; MAA under preparation) within a truly global scope and to manage and deliver the CMC Dossier with the support of the technical writing team within the Regulatory CMC.

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.

Provide operational regulatory support to a pharmaceutical affiliate in Greece, with primary responsibility for the maintenance and lifecycle management of national Marketing Authorisations (MAs), particularly for an oncology product. The role also supports regulatory activities across several European distributor markets.

Main Responsibilities:

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

This role offers an exciting opportunity to join a dynamic and ambitious team and contribute to a strategic enterprise-wide transformation program. As a Senior EDMS Migration Lead, you will play a key role in shaping the future document management landscape.

Key Responsabilities :

At Excelya, we are committed to fostering an environment defined by Audacity, Care, and Energy. As a Clinical Operations Lead , you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies.

This position offers a unique opportunity for a regulatory affairs Manager to lead strategic regulatory initiatives while collaborating with cross-functional stakeholders to ensure the highest standards of quality and compliance.

You will play a key role in driving regulatory excellence, supporting complex global submissions, and contributing to innovative development and lifecycle management strategies that shape the future of healthcare products.

Main responsibilities :