Clinical Programmer III (CP05Ti587)

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.

The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases.

We are currently looking for an enthusiastic and talented Clinical Programmer III. This role is home-based anywhere in Romania (Romanian Candidates Only and English CV required).

PURPOSE AND MAIN RESPONSIBILITIES

Purpose

The Clinical Programmer is responsible for providing Clinical Programming input per Data Management activities.  They are responsible for ensuring all clinical programming aspects per client work orders are delivered to high regulatory standards and Aixial Group SOPs.

 

Responsibilities

Operational management

·       Responsible for programming and execution of listings, using different languages as per protocol / requirements.

·       Responsible for designing reports and patient profiles.

·       Understands and strictly follows Aixial and Client’s SOPs, guidelines, and appropriate local and international legislation.

·       Clinical Programmer works under the supervision of more senior staff (manager, Team Leader, Clinical Programming, or senior Clinical Programmer).

·       Work closely with the Lead Data Manager on assigned projects.

·    Responsible for drafting Data Integration Specifications for external data vendors integration and to manage external data loading and integrations.

·       Responsible for the SAS datasets maintenance and data transfers per data transfers agreement.

·       Participate study documentation archiving.

·       Participate in regulatory audits and inspections as required.

·       May undertake other tasks as assigned by Line Manager. 

Required skills and qualities.

·       Bachelor’s degree qualification in a Scientific discipline is preferred. 

·       4 or more years as a Clinical Programmer or equivalent combination of education, training and experience.

•      Knowledge and understanding of ICH GCP and other relevant ICH, EU, or FDA guidelines to maintain regulatory compliance. 

·       Understanding of Clinical trial process and Data management activities.

Technical skills

·       Experience with programming languages, such as SAS, SQL, Python, R, JavaScript, C#.

• CDASH standards experience desirable.
• Proficient in computer technology used in an office environment (Word, Excel, PowerPoint, MS Project, etc.) 

Languages

·       Fluent English: Read, Written, Spoken.

The above job description in no way states or implies these duties are the only duties performed by this employee.  The incumbent is expected to perform other related duties necessary for the effective operation of the department and company. The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company. 

For more information on Aixial Group Recruitment and consideration for other opportunities, please review the recruitment statement on our careers page - https://www.aixialgroup.com/join-us/

Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Aixial Group HR or Talent Acquisition Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.

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Last updated on Oct 14, 2024