We are looking to hire full time Clinical Research Associates (CRA) at Accelsiors. A great opportunity to join us!

Main responsibilities:

Acts as primary individual responsible for monitoring activities with investigational sites, from site identification and selection, through site activation, subject enrolment and study conduct until close out, ensuring the clinical trial is conducted in compliance with study protocol and procedures, ICH-GCP guidelines and any applicable regulations and SOPs.

Requirements:

• Bachelor’s degree in health care or life science related field
• At least 2 years proven monitoring experience
• Strong knowledge of ICH GCP Guidelines and other applicable regulatory requirements
• Fluent in written and spoken English
• Proven ability to work independently in a fast-paced environment
• Strong communication, interpersonal, and organizational skills
• Must demonstrate excellent computer skills

Employment Type:

• Full-time, permanent

What to expect next:

If you are interested in the position, please click on the button below and send us your CV in English via our online application form.
A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

To provide Company’s full Quality Management Systems that meets global regulatory requirements ensuring that this system provides output and documentation needed to support the goals and objectives of the company and enables Accelsiors CRO and Consultancy Services to effectively work with Sponsors, Sponsor’s Vendors and Accelsiors Subcontractors.

Responsibilities

• QA Manager is responsible for establishing and management of a fully functional QA Unit maintaining, developing, and improving an effective, documented quality management system to ensure quality is built into Accelsiors work products and services.
• QA Manager will be responsible for assuring the quality of documents that are assembled to support annual reporting and other regulatory documents.
• QA Manager will support the annual review of Accelsiors Audit Plan and will work with all Accelsiors Functional Unit Heads to achieve improvement targets or resolve compliance issues.
• QA Manager will ensure that an adequate Quality Management Plan is prepared and adhered to for any Accelsiors Clinical Trial, as applicable and delegated.
• QA Manager will implement and monitor the production of any Accelsiors Functional Unit Documentation necessary to ensure that systems are developed, used and validated in compliance with regulatory requirements and Accelsiors Standards.
• QA Manager will provide training, advice and support in Quality Assurance related matters to all internal and external parties involved in Accelsiors clinical studies, i.e. Accelsiors staff (Project Leaders, Clinical Study Monitors, Data Managers and Secretaries), external clinical trial staff (field based or freelance monitors, subcontracted CRO staff), investigators and associated site personnel.
• QA Manager will ensure the local quality control of clinical trial documents prepared by the Accelsiors such as study protocols, case report forms and patient information leaflets, in compliance with SOPs.
• QA Manager will plan and/or conduct system audits of designated Accelsiors Functional Units to ensure full compliance with SOPs and implementation of local compliance systems.
• QA Manager will plan and/or conduct system audits of designated study centers and to produce detailed reports with recommendations for corrections and improvements.
• QA Manager will act as a representative of the Accelsiors Quality Assurance in the interface with the Sponsor Quality Assurance representatives, Quality Assurance Auditors, Governmental Inspections, ensuring effective communication between the Accelsiors and these parties for all matters relating to Accelsiors Quality Management System, GCP and SOPs.
• QA Manager will participate as and when appropriate in the SOPs review, with regard to the writing, reviewing, updating and translation of general and QA SOPs.
• QA Manager will be responsible for ensuring that specific requirements are implemented in SOPs of Accelsiors Functional Units wherever appropriate, and to co-ordinate the writing, reviewing, updating and validation of all Accelsiors Functional Unit SOPs.
• QA Manager will develop new- /maintain and improve the existing standards for validation of Accelsiors software, procedures (Electronic record management system, SAP, etc.) in full compliance with local and international regulatory requirements.
• Awareness of actual status of Computerized Systems (CS) used at Accelsiors.
• Facilitating the assessment of new CS.
• Setting up and managing the validation team.
• Cross-functional collaboration with other Units, teams, and individuals internally and externally.
• Preparation, approval, and execution of Validation Plan.
• Oversee validation activities, in terms of testing, documentation, reporting, user training.
• Ensuring periodic validation activities take place for existing CS.

REQUIREMENTS

• MSc/BSc degree in Scientific Discipline/ Life Sciences is preferred.
• 3-8 years’ experience in Clinical or GMP Quality Assurance.
• Thorough knowledge of Good Clinical Practices (GCPs), quality systems (SOPs) and audit
• procedures and reporting.
• Experience applying principals of 21 CFR Part 11 to clinical systems.
• Capable of writing Quality Management Documents, effective SOPs, Quality Assurance Reports, and training materials.
• Ability to facilitate meetings and to encourage participation by all team members.
• Ability to convey opinions and requests in a clear, concise, and accurate manner.
• Proactive (eager to learn) approach.
• Multitasking personality with ability to prioritize.
• Proficiency in Microsoft Office Suit (Office 365, Excel, PowerPoint…etc).
• Strong written and oral communication skills in English.
• Great attention to detail and a result driven approach.
• Excellent problem-solving skills.
• Assertive personality and strong interpersonal skills.

Didn’t find what you are looking for? Please click on the button below and send us your CV in English via our online application form.

We are looking for young people eager for learning and success to join our scientific Business Development Team, in the challenging market of clinical trials! The team is based in Thessaloniki, Greece and reaches out globally seeking new business opportunities.

You will assist in the strategy design and execution of the company’s Sales and Business Development plan. You will be promoting the company by email campaigns, teleconference meetings and calls to potential clients. Our client base varies from emerging biotech companies to large pharmaceuticals and is managed with the help of the Salesforce platform.

Furthermore, you will have the chance to work alongside a team of passionate young scientists to identify, contact and negotiate new possible partnerships. Your key qualities are self-motivation, easy communication and business curiosity.

In this position you will play a key role in expanding our client base while actively contributing to the development of the good relations with our existing and potential clients. Additionally, you will assist in shaping a business plan for a proposal to targeted clients.

Summing up, we are looking for

• young people,
• graduates preferably of Pharmacy, Biology or even Business Administration or Marketing,
• with fluency in English language,
• and very good computer skills.
• A minimum working experience of 3 years is required, preferably in sales of quality services or in Health/Pharma sector.

The required competencies are:

• Effective communication skills,
• confidence,
• flexibility,
• organization,
• attention to detail and accuracy,
• initiative and self-motivation,
• business thinking and teamwork.

We offer you an upgrade for your career in a promising, global and competitive environment. You will have the chance to learn everything about the growing market of Biotechnology and Drug Development and to develop your skills. You will have daily exposure to international environment, with excellent working conditions.

Location of Job:

• You can be based anywhere in Europe or USA, with ability to travel and meet with the team, if needed.

Employment Type:

• Full-time, permanent

What to expect next:

If you are interested in the position, please click on the button below and send us your CV in English via our online application form.
A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

We are looking to hire a full time Project Manager at Accelsiors (in Europe, flexible location).

This is key role and highly visible position within Accelsiors accountable for leading the delivery of clinical drug development studies on time, on budget and to high quality. The role involves proactive engagement with the assigned cross-functional operational project team, project sponsors and senior stakeholders.

You will lead the project lifecycle from planning, execution and close-out, proactively managing project risks and monitoring the project to assess operational performance and financial control.

Typical responsibilities comprise:

• Planning and monitoring of assigned projects
• Leading operational cross-functional project teams in a matrix environment and resource management
• Project status reporting and proactive risk surveillance
• Monitoring team and project performance against contracted milestones and KPIs
• Problem solving, risk and issue resolution including Root Cause Analysis and process improvement
• Developing and review of study plans
• Managing team resource assignments and accountability
• Participating in Bid Defence presentations in partnership with Business Development
• The Clinical Project Manager will be the back-up Sponsor point of contact to the Project Manager throughout the project lifecycle.

You will need to be an effective and diplomatic communicator with experience in project management of clinical trials gained in a previous pharma/biotech or CRO role.

Qualifications and Requirements:

• University degree, higher degree, PhD, MBA in the field of life sciences, medical sciences, pharmacy.
• At least 2 years direct work experience in a project management capacity or operational clinical trial lead role.
• Competency with project management software and tools, such as Microsoft Project, Excel, PowerPoint.
• Ability to read communication styles of team members who come from a broad spectrum of disciplines.
• Strong written and oral communication skills in English.
• Assertive personality and strong interpersonal skills.
• Ability to effectively prioritize and execute tasks in a high-pressure environment

Location of job:

Flexible location within Europe. We would be happy to discuss the role in more details upon application.

Employment Type: Full-time, permanent position

What to expect next:

We look forward to receiving your application (in English).
A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.