OPEN POSITIONS

JOB DESCRIPTION

Supporting the Senior Regulatory Affairs Managers by adhering to local regulatory requirements, applicable country specific laws and orders, not only during the application period in countries concerned by the clinical trial, but during the whole life cycle of the clinical trial as well, ensuring in this way that the regulatory compliance is met and that Accelsiors effectively works with Sponsors, Sponsor’s Vendors and Accelsiors Subcontractors.

Essential Job Functions:

• Manages the regulatory aspects of the study with regard of fulfilling the regulatory requirements. Perform all duties, under the direction of the Director Regulatory Affairs
• Serves as a secondary point of contact for Sponsor and will liaise with local Regulatory Authorities, IRB/IEC, and Principal Investigator or Sponsor as necessary
• Coordinates the submission process. Tracks and communicates status and progress of the regulatory component of the project to the project team. Responsible for preparation of authorizations needed from Sponsor, which are in accordance with local requirements.
• Uses expertise to identify potential issues and risks specific to the Regulatory Affairs
• Manages and coordinates the Regulatory Affairs Associates in regards of fulfilling the regulatory obligations during the life cycle of the projects
• Contributes to finalization of Scope of Work (SOW) for Regulatory Affairs (with Regulatory Affairs Manager, Project Manager and Sponsor)
• Assisting the Senior Regulatory Affairs Manager with the development and management of the Regulatory Management Plan.
• Creates and reviews the Standard Operating Procedures.
• Implements and maintains good communication network
• Assures that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), SOPs, GCP/ICH Guidelines, and other applicable country – specific regulatory requirements

Requirements:

• Bachelor’s level degree in life sciences, pharmacy or nursing (also with higher degree)
• Strong knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Proven ability to work independently in a fast-paced environment
• Strong leadership, communication, interpersonal, and organizational skills
• Must demonstrate excellent computer skills
• Ability to provide clear direction and guidance to others
• Position requires up to 30% travel
• Time requirements: at least 2 years of working experience in total

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.

JOB DESCRIPTION

This is key role and highly visible position within Accelsiors accountable for leading the delivery of 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.

JOB DESCRIPTION

We are looking to hire an Executive Assistant, to work as Receptionist. This is a full time, permanent position, office-based in Budapest HQ. Start date immediately. A great opportunity to join us!

Responsibilities:

• prepare and edit correspondence, communications, presentations and other documents
• file and retrieve documents and reference materials
• conduct research, assemble and analyse data to prepare reports and documents
• manage and maintain executives schedules, appointments and travel arrangements
• arrange and coordinate meetings and events
• monitor, respond to and distribute incoming communications
• answer and manage incoming calls
• receive and interact with incoming visitors
• interact with external clients
• any other task delegated by Line Manager
• general clerical duties including photocopying, fax and mailing
• maintain electronic and hard copy filing system
• retrieve documents from filing system
• schedule and coordinate meetings, appointments and travel arrangements for managers or supervisors
• open, sort and distribute incoming correspondence
• maintain office supply inventories
• coordinate maintenance of office equipment
• ensure security and confidentiality of data
• design and implement office policies and procedures

Requirements:

• High school education minimum
• Strong English language skills
• Financial knowledge would be appreciated
• knowledge of standard office administrative practices and procedures
• computer skills and knowledge of relevant software
• knowledge of operation of standard office equipment
• knowledge of principles and practices of basic office management

Core competencies:

• organizational and planning skills
• communication skills
• information gathering and information monitoring skills
• problem analysis and problem solving skills
• judgment and decision-making ability
• initiative
• confidentiality
• attention to detail and accuracy
• flexibility
• adaptability
• customer service orientation
• teamwork

Location of job: 1222 Budapest, Hungary

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.

JOB DESCRIPTION

Experienced software engineer to assist us with the maintenance, development, and implementation of our systems. The candidate must have a solid development background across multiple technical disciplines including spring web application development, Java client/server development, and Database Development.
 

The role will primarily involve server-side design and programming work, but will also include some traditional user interface and application module development as well. Responsibilities cover the entire development lifecycle, from requirements gathering and brainstorming, analysis, coding, testing and documentation.

Requirements:

• 5+ years of Java experience in developing or maintaining information systems
• Experience in design and development of multi-tier applications using Java J2EE, JSP/Servlet, Thymeleaf , Spring Framework, Hibernate, HTML, JavaScript, CSS, Jquery, AJAX, Junit
• Experience with JSON concepts and REST APIs
• Experience with applications server: Tomcat etc.
• Experience with database server: MySQL
• Experience with multiple O/S's: Windows, Linux platforms
• Written communications skills with ability to create software design and engineering documents

Location of job:

Flexible location. We would be happy to discuss the company and role in more detail upon application.

Employment Type: Full-time, permanent. Freelancer, part-time also applicable.

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.

JOB DESCRIPTION

Associate Director, Biostatistics oversees the statistical activities within the whole Biostatistics department, ensuring the timely and correct preparation of all statistical deliverables for each project. Supervises the correctness of methodologies applied by all biostatisticians working under his/her guidance. May act as a project statistician as well. Mentors younger statisticians. Learns and implements new statistical methodologies if needed.

Requirements:

• Master’s level degree in statistics, life sciences or IT related field.
• Minimum 5 years working experience in clinical biostatistics (pharma company or CRO).
• Minimum 3 years experience in SAS
• Must have a comprehensive understanding of theoretical and applied statistics, and methods of analysing clinical study data.
• Must be fully aware of Good Clinical Practice/ICH Guidelines and other regulatory guidelines in a pharmaceutical research setting and experience in clinical trials.
• Strong team contributor with effective leadership abilities.
• Ability to understand new clinical study designs, to address research questions
• High level English knowledge (written and spoken)

Location of job:

Flexible location. We would be happy to discuss the company and role in more detail upon application.

Employment Type: Full-time, permanent

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.

JOB DESCRIPTION

We are looking to hire a full time Clinical Research Associate (CRA) at Accelsiors, Italy. A great opportunity to join us! 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 written and spoken English
• Endocrinology experience is advantage
• Proven ability to work independently in a fast-paced environment
• Strong communication, interpersonal, and organizational skills
• Must demonstrate excellent computer skills
• Willing to travel approximately 40-60% nationally

Location of job:

Availability for home based position. We would be happy to discuss the company and role in more detail upon application.

Employment Type: Full-time

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.