Careers
At Heads we are always on the lookout for passionate people to expand our team. Regardless if you have years of experience on your back or looking for your first job in clinical research drop us your CV and we will make sure that it is carefully looked after.
Job Openings
Greece
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.
Italy
Heads, a global CRO, is seeking a Clinical Quality Assurance Manager (CQAM) based in Italy to join its growing interventional hematology/oncology clinical program.
This is a full-time position. It could be hybrid or remote.
The successful candidate should be certified according to Italian CRO decree (15 November 2011).
Job Description:
The CQAM has a leading role in ensuring the Company conducts clinical trials and studies to the highest quality standards, in compliance with applicable international standards, legislation, protocols, Company and Sponsors’ processes and requirements.
Main responsibilities:
-Reviews and provides input in the development and improvement of the Company’s Quality Management System (QMS) and controlled documents, pertaining to clinical operations. Drafts clinical quality documents
-Engages in the interpretation and consultation on regulations, guidelines, and standards
-Ensures clinical trials/studies compliance with GCP, protocols, local and international legislation, Company and Sponsor SOPs, Policies and Guidelines
-Delivers quality related training sessions to all staff
-Conducts clinical suppliers’ assessment and performance monitoring
-Conducts clinical trial specific documents’ audits, as well as on-site and data management audits, as requested
-Conducts quality check/audit of TMF documents (both paper and electronic), as requested
-Performs regular checks to ensure clinical trial / study specific plans are executed
-Produces clinical trial/study specific quality metrics to allow executive and operational insights into study teams’ and Sites’ performance
-In collaboration with the Quality Maintenance Manager (QMM) and the Quality Director (QD), ensures deviations, non-conformances and potential non-conformances are properly documented, addressed, and monitored for effectiveness, in compliance with the Company’s and the Sponsor’s related procedures, as applicable
-Ensures corrective and preventive appropriate action process to quality findings
-Develops periodic reports describing compliance / non-compliance trends, identifies areas of potential risk and presents to QD
-Engages in inspection readiness of Sites and operational staff
-Performs Quality Co-monitoring Visits
-Contributes to audits the Company receives from Clients and Competent Authorities
-Engages in clinical trial / study quality review and oversight meetings
Job Requirements:
-Bachelor in natural or health sciences or related field
-Master of Science in natural or health sciences or related field
-Certification of knowledge of clinical trials standards (e.g., ICH GCP etc.)
-Certification of knowledge of quality assurance standards (e.g., ISO 9001, etc.) (strong advantage)
-Previous Work Experience:
- Proven experience as a Clinical Quality Assurance Manager / Senior GCP auditor or 5-year minimum experience in quality for clinical trials in CROs and/or pharmaceutical companies
- Previous experience with GCP system audits, Site and documentation audits and/or regulatory inspections
- Certified as an Auditor according to the Italian CRO Decree
-Excellent command of spoken and written English
– Other languages considered an asset
-Great attention to detail and a result-driven approach
-Reliable and trustworthy
-Planning and organization skills
-Outstanding communication and interpersonal skills
-Problem-solving skills
-Good knowledge of MS Office and databases savvy
-Advanced numerical skills and understanding of data analysis / statistical methods
-Ability to deal adequately with stressful situations, flexible timelines and work pressure
-Team working skills
-Willingness to travel
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.
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