Gouya Insights Careers

Do you want to work with an amazing team to bring medical and pharmaceutical innovations to market? Check out our Gouya Insights Careers!

We are so excited for your interest in working with our amazing clinical development team. Please check our Linkedin Company page for more job opportunities and to check if the job postings listed below are still open! If nothing is currently available, please use the form below to submit your resume and we’ll be sure to contact you if there is an opening. 

Job Description Clinical Trial Assistant at GOUYA INSIGHTS

We are looking for a talented clinical trial assistant (CTA) who will provide project related assistance for assigned project(s) and project teams. The CTA will ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics. If you love to be part of a great enthusiastic team and support challenging project in clinical drug or medical device development and digging into the optimization of project related processes, you’ll be welcomed with open arms at Gouya Insights. Any previous experience in clinical research will be valued deeply as well.

What you will be responsible for:

  • Take and record minutes, notes, and actions at assigned meetings, distribute, and follow up accordingly.
  • Study progress tracking:
    • To process Study enrolment tracker, Document versions tracking, Monitoring Visit trackers and other clinical trial related trackers.
    • To assist project teams with trial progress tracking.
  • Project tools:
    • Maintenance of Study Contact list, Study team organigram (CPM initialize, CTA maintain)
  • eTMF administrator – set up, maintenance and final reconciliation (responsible CTA, accountable CPM)
  • Develop folder structure new project.
    • To set up, organize and maintain clinical study documentation including preparation for internal/external audits, final reconciliation and archival.
  • To develop respective documentation logs/ forms according to study plans/ manuals
    • To ensure correct formatting and design of documents developed by CPM (plans, manuals, newsletters)
  • To contact other CROs/ clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
  • To coordinate the tracking and distribution of safety reports.
  • To coordinate document translation, if required.
  • To attend project team meetings and generate meeting minutes.
  • To assist the Project Manager and project team with Investigator meeting/Kick-off meeting coordination, activities preparation and generate meeting minutes.
  • Support the preparation of presentation materials for meetings (internal/external) and project summary data.
  • Coordinate of project team and/or customer meetings including logistics and materials required.
  • To set up, organize and maintain clinical study documentation including preparation for internal/external audits, final reconciliation and archival.
  • To process Data Collection Forms i.e., log in, tracking, quality control as appropriate for the study.
  • To provide general administrative support to the Clinical Project Teams.
  • To assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
  • To be familiar with ICH GCP, appropriate regulations and ensure regulatory adherence and control and relevant documentations.
  • To support in quality control audits of clinical study documentation.
  • To co-ordinate dispatch and tracking of trial materials.
  • To contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).

 

What you bring to the table

  • Good teamwork skills
  • Problem solving skills.
  • Results and detail-oriented approach to work delivery and output
  • Ability to prioritize own workloads to meet deadlines.
  • Strong software and computer skills, including MS Office applications
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
  • Excellent English written and spoken language skills.
  • Higher studies in life sciences or equivalent combination of education, training, and experience.

Benefits

  • Vision – Work on exciting and innovative drug and medical device products that really add value to our customers and patients’ lives. Creative freedom in the further development of our company
  • Ambition – A highly ambitious clinical development company that is constantly growing
  • Culture – A start-up atmosphere and team events throughout the year to foster the company spirit and make you feel right at home. We are a very close and friendly team, and we are going to keep it that way
  • Work environment – A highly flexible work setting, either from our modern office in the most liveable city in the world – Vienna, from home, or even remotely (position-dependent). You will be given breathing room and autonomy to make impactful decisions
  • Compensation – A competitive salary and 25 holiday days
  • Personal growth – A yearly learning allowance to pay for relevant training and certificates to help you grow with the company
  • Wellbeing – Free snacks, great coffee, and many other beverages to keep you hydrated, caffeinated and ready to crush the day

 

A Bit About Us…

At Gouya Insights, we see a future in which we can drive global innovation in drug and device landscape to the clinical development and to the market launch for the benefit of patients across the globe. For clinical development expertise there will be only one place to go: Gouya Insights. As experts in clinical development, we create the clinical roadmaps for biotech companies, start-ups, pharmaceutical companies, and medical device manufacturers. In addition to our consulting activities, Gouya Insights takes over the management of clinical development for clients, including the creation of an efficient roadmap for the development program. This includes obtaining scientific recommendations, assembling a clinical operations team, and acting as an interface between sponsors and clinical operations for oversight through to conducting clinical trials and reviews of medical data. In addition, Gouya Insights assists with medical writing, i.e., clinical study reports and their publication.

If you are interested, please send your CV and a motivation letter to:

gouya@gouya-insights.com

Apply to this job on LinkedIn!

Summary:

We are strategic clinical innovation experts working with biotech, academic start-ups, pharmaceutical and device companies. Gouya Insights translates innovation into a clinical roadmap and designs the most efficient clinical development plan. We are seeking a driven and entrepreneurial data manager to lead the development of data management processes in clinical study teams. The overall scope of the job position encompasses planning, processing, design, implementation, validation and controlling of electronic data capture system for clinical trials. Management of data and compliance to regulatory requirements; further creation of study related documents with documentation of standardized procedures during Data Management (DM).

Tasks and Responsibilities:

  • Act as the functional lead in the development and conduct of Data Management processes in clinical study teams
  • Design and implement electronic case record forms within different Electronic Data Capture (EDC) vendors
  • Liaise with (EDC) vendors, contractors and new business units to seek new ways to improve data systems or reduce costs of current systems and regularly troubleshoot processes to ensure most time and cost-effective practices
  • Aid in the evaluation and selection of EDC vendors according to project specific needs
  • Monitor and manage clinical study data collection for clinical studies
  • Conduct quality control and quality assurance on the database and data entered
  • Generate reports of data status for internal working groups and stakeholders
  • Develop, update/review and/or approve study documents as required by standard operating procedures. (e.g. study protocols, Project specific Case Report Forms (CFR), CRF Guidelines, Data Management Plans, Data Quality Check Specifications, etc.)
  • Oversee the development of Standard Operating Procedures (SOPs) and guidelines relating to Data Management company practices
  • Supervise and direct the daily activities of the Data Management staff
  • Select methods and techniques for obtaining solutions in close consultation with the principal investigators (PIs) and other stakeholders
  • Monitor and evaluate performance taking corrective actions as needed to achieve organizational objectives
  • Propose resolutions and mitigations to the project team and/or the Sponsor and track issues and risks through to project completion
  • Determine status of incoming data, site responsiveness, and need for escalation of backlog to various functions
  • Report and discuss findings with the Management Team within Clinical Data Management and, as necessary, Project Management
  • Participate as a subject matter expert in comprehensive training and education of project specific Data Management conduct

 

Required knowledge/skills and abilities:

  • Advanced higher educational degree in a STEM subject, preferably in mathematics, informatics, data science, biomedical engineering or equivalent combination of education, training, and experience
  • Experience in maintenance and storage of large amounts of data.
  • Knowledge of database concepts and proficiency in SQL.
  • Good working knowledge in at least on Programming language (e.g. R, Python, Matlab, SAS, …)
  • Previous professional experience in Data Management. Experience in Clinical Development is a plus
  • Excellent verbal and written English communication skills
  • Ability to work and apply knowledge and skills independently in a highly organized fashion while adhering to regulatory guidelines, SOPs, and client expectations
  • Strong attention to detail and analytical mindset
  • Strong sense of ownership and willingness to improve current processes
  • Strong customer focus and excellent interpersonal skills.
  • Ability to communicate data related topics clearly and effectively to various stakeholders.

 

Please send back you motivation letter and your curriculum vitae to:

PD Dr. Ghazaleh Gouya-Lechner

gouya@gouya-insights.com

Or apply to this job on LinkedIn!

Resume Submission