Ref #: 28800

Employment type: Permanent - Full-Time

Location: Kuala Lumpur

Posted: 29-Apr-2021

Description

If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring a Clinical Trial Assistant to work closely with our client, a leading pharmaceutical company.


Description:
•* Partners with the LTM and Site Manager to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements.
•* Supports the local study team in performing site feasibility and/or country feasibility.
•* Maintains site level protocol information in Trial Management Systems (e.g. CTMS).
•* In liaison with the LTM, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.
•* Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval process.
•* Supports the LTM or, where applicable the SM, in providing the current and complete documents requested by the IEC/IRB and HA.
•* Supports the SM/LTM in collecting and maintaining all documents throughout the trial and post-trial in both eTMF(i.e., IF/LAF sections) and paper files.
•* Distributes, collect, review, and track regulatory documents, agreements and training documentation.
•* Collects and tracks Financial Disclosure information at appropriate time points.
•* May contribute to process improvement including, but not limited, to representing functional area in process initiatives and contribute to optimization of daily processes.
•* May be assigned as a coach and mentor to a less experienced CTA.


Profile:
* Skills set corresponding with preferentially 2+ years relevant clinical trial experience or equivalent.
* Proficient in English language.
* Strong knowledge with MS Office (Word, Excel, Access, Outlook , Explorer and PowerPoint)
* Strong interpersonal and negotiating skills.
* Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
* Perform activities in a timely and accurate manner.

Why join the DOCS team at ICON?

Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.

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