Our Company

Start your career in Accelsiors!

Accelsiors is an equal opportunities company. We expand our team by assessing the candidate's competencies and professional experiences. Please apply directly for the open position listed below.

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People are at the heart of everything we do. With us, you will get the opportunity to develop in the highly complex but fascinating field of clinical trials. Join Accelsiors’ scientifically-driven team, and be part of the acceleration of clinical drug development worldwide!

Open positions

CRA in GERMANY

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.

QUALITY ASSURANCE MANAGER

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.
JOIN OUR TALENT NETWORK!

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.

A member of our recruitment team will review your professional background & qualifications, and if interested, we’ll keep you informed of Accelsiors’ career opportunities matching your interest areas.

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JOIN OUR TEAMSubmit your CV

We look forward to receiving your CV (in . PDF format) and hope to contact you soon.
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