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

Clinical Research Associate

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.

Apply

Clinical Trials Start-Up & Regulatory Officer

Health Data Specialists (HeaDS),  is seeking a Clinical Trials Start-Up & Regulatory Officer to undertake the submission activities for assigned clinical trials in Europe.

This is an office-based job in Athens City, Greece.

Main responsibilities:

  • Collaborates with cross-function team to prepare clinical trial applications, amendment submissions & other notifications for assigned studies within a European country
  • Contract & budget negotiation: set-up, obtain review and approval of clinical trial agreements, confidentiality agreements, letters of intent etc. to ensure timely clinical trial start and compliance to the applicable local legislation
  • Acts as a primary contact with research sites during site start-up activities
  • Provides progress reports for submission status & expected timeframe
  • Ensures that start-up documentation is kept up to date; maintenance of internal systems & tracking tools
  • Maintains up-to- date knowledge, ensure adherence and compliance with regulatory requirements & relevant rules governing the conduct of clinical trials

Required Qualifications:

  • University/College degree
  • 2 years work experience in the clinical research or regulatory field will be preferred
  • Previous experience with Investigators’ / sites’ start-up documents is preferred
  • Experience in working with cross-functional teams; good understanding of working in a team environment
  • Proficient computer skills (e.g. Microsoft Word, Excel, and PowerPoint)
  • Excellent organizational and communication skills
  • Capable of multi-tasking and working well under pressure to meet deadlines
  • Foreign languages:
    • English: proficient
    • Full professional fluency in at least 1 main European Language (Italian, French, Spanish, German, Dutch) will be considered a very strong asset

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.

Apply

SAS Programmer

Health Data Specialists, “HeaDS”, is seeking for a SAS Programmer.

As a SAS programmer, you will be responsible to provide clinical programming expertise and support to clinical studies across multiple therapeutics areas, through strong technical SAS programming input to the Data Management Team.

The SAS programmer role will be based in Athens City, Greece.

Main responsibilities:

      • Write, maintain and validate SAS programs to create templates and utilities for data cleaning and reporting.
      • Develop tables, listings and figures outputs with the use of SAS best practice programming techniques.
      • Create data quality and data completeness reports as required.
      • Program edit checks to ensure data quality.
      • Develop SAS programs to create SDTM and ADaM datasets in accordance with CDISC standards and implementation guides.
      • Perform data transfer to external recipients.
      • Provide expertise to the data management team, with respect to the SAS programming activities.
      • Work closely with other programmers, statisticians, data managers, and database programmers to ensure accurate and high-quality deliverables.

Minimum requirements:

      • At least 2 years of SAS programming experience in clinical studies in a CRO, pharma or equivalent institution.
      • Bachelor’s or MSc degree in statistics, mathematics, biostatistics, computer science, or related field is required.

Desirable Skills and knowledge:

      • SAS Certified Programmer.
      • Strong communication skills and ability to work in a collaborative environment.
      • A genuine interest in the field of clinical development.
      • Strong organizational, problem-solving, and decision-making skills.
      • Be flexible and result-oriented.
      • Demonstrated knowledge of CDISC and SDTM standards.
      • MSc or a PhD in a relevant to the role field.

Join us to be part of a multidisciplinary team of highly skilled scientists in the forefront of clinical research within a friendly work environment. Competitive remuneration package comes on top.

Apply

Clinical Data Manager

Health Data Specialists (HeaDS),  is seeking a Clinical Data Manager (CDM) with analytic and programming skills, responsible for HeaDS NIS program as part of the Biostatistics & Data Management team.

The CDM role will be based in Athens City, Greece.

Desirable skills:

  • Strong individual initiative, with a genuine interest in the field of clinical development.
  • Excellent organizational and communication skills.
  • Able to work with minimum supervision under tight timelines on multiple projects.

Main responsibilities:
A successful CDM candidate will:

  • Be accountable for the DMP, data validation plan and for the preparation/review of the reports that derive from these plans.
  • Guide the development of the CRF of clinical studies.
  • Guide and approve the User Acceptance Testing (UAT) activities of the Electronic Data Capture system developed for Non-Interventional studies.
  • Guide and overview the clinical Data Validation and Data Cleaning activities.
  • Be responsible for the study status oversight with respect to data, using reports (data entry, queries, SDV, safety reconciliation etc.) and communicate efficiently the status to the team.
  • Develop summary tables, listings and figures using MS Excel or other programs (i.e. SAS, SQL).
  • Perform Quality Control on final plans and reports.

Minimum qualifications:

  • BSc/MSc degree in mathematics, statistics, data science, biostatistics or other applied sciences.
  • Excellent MS. Office command.
  • Excellent written and verbal command of the English language
  • Hands on experience in SAS programming or other data programming language
  • Hands on experience with SQL will be considered as a plus.

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.

Apply

Clinical Project Manager

Health Data Specialists (HeaDS), is seeking a Clinical Project Manager for its international Clinical Trial operations.

The Clinical Project Manager role will be based in Athens City, Greece and will be involved in multi-center global interventional Clinical Trials across multiple Therapeutic Areas, with key focus on Oncology/Hematology.

The Clinical Project Manager will:

      • Manage the technical, protocol-specific and operational aspects of assigned studies to ensure that project deliverables meet the agreed expectations.
      • Resource, organize & provide leadership to a cross-functional team in accordance with applicable project plans, SOPs, ICH/GCP and regulatory requirements.
      • Create project management reports, plans and tools.
      • Oversee performance of third party vendors.
      • Develop and execute risk management strategies and mitigation plans.
      • Confirm and apply quality control activities.
      • Manage the study budget.
      • Participate in the training and development of the clinical study team.
      • Perform co-joint monitoring visits as needed.
      • Review and approve site visit reports; ensure tracking, follow up and resolution of site issues has been completed in a timely manner.

Job Requirements:

      • Bachelor’s and/or master’s degree (in Health Sciences preferred).
      • Previous work experience:
        • Minimum 2 years’ experience as Clinical Project Manager.
        • Minimum 5 years’ experience with clinical trial conduct.
        • Experience in managing or coordinating international multi-center trials is highly desired.
      • Advanced user of Microsoft Office Suite; experience with project management software is desired.
      • Ability to handle complex projects; flexibility in managing changing priorities; strategic problem solving and judgement skills.
      • Capable of managing multiple projects, timelines and responsibilities.
      • Excellent written and verbal communication skills in English.
      • Ability to work with minimal direction.
      • Initiative taking and team working attitude.
      • Knowledge of ICH/GCP guidelines and regulatory requirements.
      • A genuine interest in the field of clinical development.
      • Willingness to travel approx. 20% of the time, including domestic and international 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.

Apply

Ireland

SAS Programmer

Health Data Specialists, “HeaDS”, is seeking for a SAS Programmer.

As a SAS Programmer, you will be responsible to provide clinical programming expertise and support to clinical studies across multiple therapeutics areas, through strong technical SAS programming input to the Data Management Team.

The SAS Programmer role will be based in Dublin City, Ireland.

Main responsibilities:

      • Write, maintain and validate SAS programs to create templates and utilities for data cleaning and reporting.
      • Develop tables, listings and figures outputs with the use of SAS best practice programming techniques.
      • Create data quality and data completeness reports as required.
      • Program edit checks to ensure data quality.
      • Develop SAS programs to create SDTM and ADaM datasets in accordance with CDISC standards and implementation guides.
      • Perform data transfer to external recipients.
      • Provide expertise to the data management team, with respect to the SAS programming activities.
      • Work closely with other programmers, statisticians, data managers, and database programmers to ensure accurate and high-quality deliverables.

Minimum requirements:

      • At least 2 years of SAS programming experience in clinical studies in a CRO, pharma or equivalent institution.
      • Bachelor’s or MSc degree in statistics, mathematics, biostatistics, computer science, or related field is required.

Desirable Skills and knowledge:

      • SAS Certified Programmer.
      • Strong communication skills and ability to work in a collaborative environment.
      • A genuine interest in the field of clinical development.
      • Strong organizational, problem-solving, and decision-making skills.
      • Be flexible and result-oriented.
      • Demonstrated knowledge of CDISC and SDTM standards.
      • MSc or a PhD in a relevant to the role field.

Join us to be part of a multidisciplinary team of highly skilled scientists in the forefront of clinical research within a friendly work environment. Competitive remuneration package comes on top.

Apply

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