Avenga is a global IT and digital transformation champion. We deliver strategy, customer experience, solution engineering, managed services, software products and outsourcing services like: staff augmentation, team leasing and permanent employment.Together, we are more than 2500 professionals with over 20 years of experience. We are present in Europe, Asia and the USA.
Clinical Study Support Professional
Miejsce pracy: woj. lubuskie Nr ref.: LP/CSSP/ZD/07
Avenga jest światowym ekspertem w obszarze IT i transformacji cyfrowej.
W ramach linii Transforming Industries świadczymy szeroką gamę usług – od doradztwa strategicznego, usług związanych z customer experience, projektowaniem rozwiązań, po tworzenie oprogramowania. W ramach obszaru Avenga IT Professionals oferujemy outsourcing najwyższej klasy specjalistów w trzech modelach współpracy: staff augmentation, team leasing i rekrutacje stałe.
Łączymy kreatywność i innowacyjność z umiejętnością szybkiej realizacji kompleksowych projektów nastawionych na uzyskanie wymiernych korzyści oczekiwanych od dużego dostawcy rozwiązań IT.
Avenga to ponad 2500 profesjonalistów i 20-letnie doświadczenie w realizacji projektów IT.
Jesteśmy obecni w Europie, Azji i USA. W Polsce działamy od 2004 roku (poprzednio pod nazwą IT Kontrakt).
Avenga is a global IT and digital transformation champion. We deliver strategy, customer experience, solution engineering, managed services, software products and outsourcing services like: staff augmentation, team leasing and permanent employment.
Together, we are more than 2500 professionals with over 20 years of experience. We are present in Europe, Asia and the USA.
Provide operational support for remote patient monitoring solutions in studies, including by being a point of contact for support requests by physicians and study coordinators
Develop translation, logistics, support and related processes, and select/manage vendors that provide these services
Ensure support requests are promptly addressed by the digital biomarker team
Preparation of site supporting materials, including training materials
Assist with preparing remote patient monitoring parts of IRB/Ethics Committee submissions, and addressing follow up questions
Create and maintain accurate study level progress information (e.g. recruitment status, remote patient monitoring data generation levels, data transfer status, technical issue overviews) through the efficient use of systems, tools and reports.
Create and maintain centralized project/team work-spaces, including document creation and/or maintenance.
Assist with effective communication and information sharing via compilation of study-specific documents and resources (agendas & minutes, presentations, team contact lists, distribution lists and other relevant material).
Identify and contribute to areas of best practice and process improvements.
Proficiency with MS Office suites such as Excel, PowerPoint, Word
Work time zone: CET (apac also acceptable)
In case of any additional questions, please contact Justyna Fabisiak (DM)
Job description:It is quite important that the new hire has knowledge and experience of clinical trials, Ideally 1/2 years experience in the CRO, pharmaceutical or biotech industry as any of the following:
-clinical trial coordinator (COC)
-clinical trial associate (CTA)
-and/or experience in trial monitoring is welcome, but not mandatory
-clinical research associate (CRA)
-in house CRA
Central monitor associate (CMA/SMA)
As a set of skills that would be beneficial:
Good knowledge of clinical trial activities from start up to close out.
Understanding of clinical trials processes, and terminology
Good understanding of ICH -GCP and ALCOA principles
Experience with ePRO/eCOA solutions
Strong communication, interpersonal, and organizational skills.
Basic experience with project/trial management
Knowledge of the drug development process
Strong affinity to digital technologies
Fluent in English
Strong affinity to IT
Other set of skills that would be beneficial but not essential are:
clinical trial management
experience in neurology either as clinical trial manager or trial monitor
vendor management experience
In summary we are looking for young professionals that have experience in clinical trials but are also interested and passionate about technology.
Passion for digital innovation in healthcare, and especially for leveraging novel technologies to modernize clinical endpoints and improve disease/treatment management
Experience with vendor management
Very good university degree (BA. level or above) or equivalent work experience
Relevant work experience, e.g. in the pharmaceutical or related industry, in clinical operations, or in a customer service and support function
Excellent analytical skills
Excellent communication and presentation skills
Self-starting team player
Problem solving attitude and structured approach to work
Native English or equivalent
Nice to Haves:
+++ Previous experience working for an eCOA (electronic clinical outcome assessment) vendor
+++ Previous experience in working with patients and clinical trials
+++ Roche experience
Please include in your application the following consent:I agree to the processing of my personal data provided by me, not mentioned in art. 221 § 1 of the Labor Code, or other specific provisions applicable pursuant to art. 221 § 4 of the Polish Labour Code, in order to recruit by the Administrator - Avenga IT Professionals Sp. z o.o. with registered office in Wrocław, ul. Gwiaździsta 66, 53-413 Wrocław, for the position Clinical Study Support Professional.