Careers

Health Data Specialists (Heads), an Athens based CRO with a global reach, is seeking a CRA for its international Clinical Trials program.

The CRA role will be based in Athens and be involved in Clinical Trials across multiple Therapeutic Areas, with key focus on Oncology/Hematology.

Job Description:

• Participate in the site selection process.
• Execute operations on new and on-going clinical research projects to ensure successful project deliverables.
• Perform all site monitoring visit activities, inclusive of all study visit types, as per protocol requirements and serve as the principal point of contact for investigational sites.
• Manage timely subject enrolment, assisting in the development of patient recruitment strategy and quality data collection.
• Ensure patient safety is maintained and informed consent procedures are carried out.
• Prepare and update the Clinical Trial Files, ensuring the proper collection of essential documents.
• Verify the receipt, handling, accounting, storage conditions and availability of clinical products.
• Liaise with vendors such as central laboratories as required to ensure protocol adherence and ensure investigational sites have appropriate clinical supplies.
• Participate in study specific conference calls and meetings to review projects’ progress.
• Communicate effectively with team members and management to relay protocol/study issues and implement necessary actions in response to those issues.
• Establish updates, tracks and maintaining study specific trial management tools/systems, and status reports as required.
• Assess adherence to SOPs, GCP and all applicable regulatory requirements.

Job Requirements:

• Bachelor’s and/or master’s degree (preferred in Health Sciences)
• Previous Work Experience: -1 year work experience as a CRA (Oncology/Hematology preferably)

• Very strong written and verbal communication skills in both Greek and English
• Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
• High organizational and logistical skills to ensure effective management of multiple sites and protocols within timeframes
• Strong ability to build and maintain relationship with investigators, member sites and with pharma/biotech companies for business relations
• MS Office (Excel, Word, Power Point)
• Ability to travel

Join us to be part of a multidisciplinary team of highly skilled professionals in the forefront of Clinical Research within a friendly work environment.

Competitive remuneration package comes on top.

Heads, a global CRO, is seeking a Quality Maintenance Officer (QMO) based in Athens (Greece) to join its growing interventional hematology/oncology clinical program.

This is a full-time position.

Job Description:

The Quality Maintenance Officer (QMO) has a key role in supporting the development, implementation, and maintenance of the Company’s Quality Management System (QMS), as well as in the maintenance of the Company’s Information Security Management System (ISMS) and

participates actively in continuous quality improvement activities.

Main responsibilities:

-Supports the development, implementation, and maintenance of the Company’s QMS

-Supports the Information Security Manager and the Company’s Data Protection Officer in the maintenance of the ISMS

-Collaborates with internal departments for the development of operational controlled documentation

-Maintains the Company’s Training Matrix, Curricula and Regular Training Schedule

-Ensures employees qualification and training records are maintained and updated

-Supports quality change management activities

-Supports the management, follow-up and closure of deviations, non-conformances and potential non-conformances

-Manages clients’ satisfaction measurement and supports complaints handling activities

-Supports the Quality Objectives and Key Performance Indicators (KPIs) monitoring process

-Archives QMS documentation and maintains the quality repository always updated

Job Requirements:

-Bachelor in natural or health sciences or related field

-Master of Science in natural or health sciences or related field (desirable)

-Previous Work Experience:

• 1-year minimum experience in Quality Management System and Information Security Management System or equivalent quality management or assurance experience
• Proven knowledge of ICH GCP (desirable)

-Excellent command of spoken and written English

-Attention to detail

-Reliable and trustworthy

-Proactive orientation and positive solution-driven person

-Initiative taking and team working attitude

-Good knowledge of MS Office

Join us to be part of a multidisciplinary team of highly skilled scientists and healthcare professionals in the forefront of Clinical Research within a friendly work environment.

Competitive remuneration package comes on top.