Clinical Operations Specialist (CTA) - Sweden, Solna - Sponsor-dedicated
Here at Syneos Health we are currently recruiting for a Clinical Trial Assistant to work with one of the largest and most successful Pharmaceutical companies in the world. Employment would come from Syneos Health and you would be outsourced to this client.
- Setting up vendors during study start up period (operational details from sites)
- Enter necessary data / tracking in systems (i.e.ECLIPSE, eTMF, SAP)
- Responsible for documentation within the electronic master file (uploading / completing documents) & other systems (i.e., document exchange portals like Mytrials/Shared Investigator Portal) including conduct of completeness checks
- Arranging drug and non-drug (Lab kits, ECG) importation to support study site
- Complete all payment activities including preparing invoices, Payment Due Reports and creating fund/PO
- Collect and distribute documents from / to sites during study life cycle
- Coordinate study related materials (i.e. protocol, Informed Consent Form(ICF), patient material) for translation
- Coordinate study related documents (IB, Protocol, Site ICF etc.) for printing and binding
- Administrative support to the study team (study related mailing, bill processing, printing, translation etc.)
- Obtain Insurance certificates
- Preparing On Site Investigator File and other study related files
- Support equipment calibration and tracking
- Archiving process handling at study closure
- May support Local GRS in preparing and/or performing submission for Health Authorities including follow up until approval. This could include preparation and/or submission of substantial amendments.
- May prepare and perform submission for Ethics Committees including follow up until approval (protocol, amendments/IB)
- May support Health Authority inspection and pre-inspection activities
- May support audit preparation & Corrective Action / Preventative Action preparation for local related issues
The ideal candidate will need the following experience / skills to be considered
- Experience in CTA role is required
- Experience in the use of industry Clinical Trial Management System and Clinical Trial Master File Systems or equivalent preferred
- Additional complex software application related to clinical trial research (i.e electronic data capture or patient diaries, interactive voice response, etc…) preferred
- Basic understanding of GCPs, ICH Guidelines and local regulations as they apply.
- Basic knowledge of the drug development process as it relates to the execution of clinical trials with a focus on document flow.
- Experience in managing multiple priorities and able to accomplish tasks within a timeframe, setting milestones to meet deadlines and to achieve goals.
- Demonstrates ability to function independently
- General knowledge of software systems and web-based applications. Good computer aptitude and willingness to learn new systems and applications.
- Good verbal and written communication skills (both in English and local language).
- We have a comprehensive benefits package and offer highly competitive remuneration.
If you have the required experience for this position and are eligible to work in the required location then please apply by CV or contact me directly on: [email protected]
To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/
Please be advised that due to volume of received applications, only selected candidates will be contacted back.
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.
Primary Location: Europe - SWE-Client-Based
Job: Clinical Monitoring
Employee Status: Regular
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