Clinical Trial Associate, sponsor based, Sweden
Office based in Stockholm
Here at INC Research/ inVentiv Health Clinical we are currently recruiting for a Clinical Trial Associate to be based in one of our clients office in Stockholm.
As a CTA you would administer, maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs) covering Denmark, Norway, Finland and Sweden.
* To handle all study related administrative tasks by utilizing technology effectively to support the clinical trial development processes with the use of Clinical Trial Management System at the Protocol, Country and Site level.
* Ensure that any clinical trial databases/ tracking tools are set up and maintained throughout the trial
* Collaborate with the study project team to reach target within set timelines
* Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study.
* Set up and maintenance of the Trial Master Files (VEVA), Electronic filing systems/ set up of the Investigator Site File
* Coordinating archiving of study documents
* Managing and maintaining study documents & trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits and Medical equipment for sites and re-ordering supplies.
* Preparing essential clinical trial documentation, distributing, tracking and filing of documents.
* Understands basic financial analysis of a clinical trial budget and has the ability to track and manage study related contract and payments.
* Effectively uses available tools and systems to gather information needed to manage study activities and to provide feedback to the appropriate BMS team members.
* Identifies potential issues and suggests resolutions. Answers and resolves routine questions independently.
* Education related to health sciences, nursing or pharmacy or related field are preferable, but not a must
* Proven experience working as a CTA in Clinical Research or in the Pharmaceutical Industry
* Knowledge of the Industry/Clinical trial process and drug development and of ICH GCP
* Experience in multitasking and prioritizing
* Excellent organizational skills and good attention to detail
* Ability to decision making, problem-solving, providing contingency plans
* Able to work with flexibility and independently
* Experienced with IT-technology as e.g. word-processing, presentation graphic, spreadsheet, database, and file management (ARIBA, ECLIPSE, SAP)
* Good verbal and written communication skills (both in English and Swedish), Finnish is a plus.
* Competitive remuneration package with excellent benefits
* Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
* Opportunity to work within a successful and rewarding environment.
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You'll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA