OPEN POSITIONS

JOB DESCRIPTION

We are looking to hire full time Clinical Team Managers (CTM) at Accelsiors in Europe and the USA. A great opportunity to join us!

The Clinical Team Manager (CTM) is responsible for the coordination of the Clinical Operations team at the project level, and the timely execution of all clinical deliverables per the project contract and management plan. This role is reporting to VP Clinical Operations.

Some of the responsibilities are the following:

• To maintain awareness of the scope of work for clinical activities in the assigned studies and escalate any potential out of scope activities to the Project Manager.
• To be the primary owner of all clinical deliverables, ensure clinical timelines (milestones) are met and serve as the project primary point of contact for any clinical activity and issue.
• To oversee clinical team’ workload and support the Project Manager and Line Managers in appropriate clinical resources allocation.
• To prepare and deliver project-specific training to the clinical team.
• To prepare and maintain study-specific clinical tools, templates, plans and trackers throughout the project life.
• To lead regular calls with the clinical team in order to obtain the study-, countries- and site-level status and priorities and to discuss and address all clinical-related issues.
• To attend internal and external project team meetings in order to present and discuss all ongoing clinical activities status and issues.
• To drive/coordinate the preparation of the Informed Consent Form and all other patient facing materials, including clinical input to the master version(s), customization of country- and site-specific versions, management of the translations, distribution among the involved project team members and appropriate tracking of each step.

Requirements:

• Requires Bachelor’s level in science/health care field.
• A minimum of 5 years of experience as CRA and/or at least 1 year of previous CTM role or equivalent experience within CRO industry.
• Strong organizational skills, proactivity, flexibility, and team-oriented approach with an ability to motivate both individuals and a team.
• Strong time management skills and Strong communication skills, knowledge of business language and ability to communicate with all internal and external stakeholders.
• Proficiency level in English, both verbal and written.

Location of job:

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

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.

JOB DESCRIPTION

This is your chance to be a member of Accelsiors’ Global Data Management l team.

We are looking for an experienced Project Data Manager, to support moderate to complex clinical trials.

Responsibilities:

The Project Data Manager is accountable for accurate delivery of high-quality clinical data as per agreed timelines. Core responsibilities are:
 

• Participates in advanced planning and risk management for projects. Prepares mitigation plans as needed.
• Represents DM at internal and external meetings.
• Reports status updates and performs root cause analysis on identified backlogs.
• Authors/reviews Data Management section of the protocol.
• Communicates with contracted central laboratories and other External Service Providers.
• Establishes and maintains a trusted relationship with Sponsors.
• Develops and maintains the Data Management Plan (DMP) and other data management documentation. Ensures Data Management documentation is inspection ready at all times.
• Prepares/reviews of CRF specification documents, including edit checks specifications.
• Serves as a SME for for Dm and technical related aspects for the project team and Sponsor.
• Leads query generation/handling and performs query QC activities.
• Leads interactions and collaborates with the project team and representatives from other departments.
• Participates in and presents at internal, client and investigator meetings.
• Jointly with immediate management, assesses data management resource needs and manages assigned resources.
• Takes active part in software validation process in terms of testing and documentation.

Mentor junior Data Manager activities:

• Provides training to junior staff if required
• Ensures junior staff is performing study related activities as per agreed plan
• Reviews resource allocation for the assigned projects

Non project related activities:

• Through continuous improvement activities, support the development of the Data Management Team.
• Identify gaps in processes and propose corrective action.
• Supports the team in developing standards.
• Take part in SOP development as well as Data Management templates.
• Act as a Data Management advocate within Accelsiors organization.
• Continuously explore new trends/developments in the industry.

Required Qualifications:

• Degree/higher degree in statistics, life sciences, pharmacy, nursing or RN, mathematics or IT related field.
• Seven years of previous experience with clinical trials and data management.
• Excellent command of English language, oral and written.
• GCP knowledge, CDMS knowledge (IBMCD (ICD) preferred).
• Organization, leadership, time-management, analytical and presentation skills.

We offer you the chance for advancing your career within a growing global company, in a promising and competitive environment. Excellent working conditions, competitive salary plus ticket restaurant and bonus system.

The candidate, ideally, should be based in Thessaloniki, Greece but a remote location can be discussed.

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.

Accelsiors in a glance
Accelsiors is a global scientifically driven, full-service CRO, with over 20 years of experience in clinical research. We are present across 40 countries on 5 continents, ready to provide high quality clinical services. We support and accelerate each step of the clinical drug development, from the preclinical stage with gap analysis and protocol consultancy, throughout the whole clinical development, until regulatory submission for marketing authorization. Our clinical research experience covers a broad range of therapeutic areas throughout all the phases of a trial.

JOB DESCRIPTION

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.