Position Title Clinical Trial Document Management

Job ID	128455BR
Division	Alcon
Business Unit	Alcon
Country	Australia
Work Location	Frenchs Forest
Company/Legal Entity	ALCON AUS
Functional Area	Development & Medical
Therapeutic/Disease Area	Ophthalmics/Ophthalmology
Job Type	Full Time
Employment Type	Regular
Job Description	As the global leader in eye care, Alcon’s mission is to provide innovative products that enhance quality of life by helping people see better. This mission means that Alcon’s more than 22,000 associates strive to make significant contributions to preserve, restore and enhance vision. Through the merger of Novartis and Alcon, uniting the strengths of Alcon, CIBA VISION and Novartis Ophthalmic into one eye care business, Alcon has become the second largest division of Novartis. With these collective resources and scale, Alcon now offers the widest spectrum of eye care products in surgical, pharmaceutical and vision care across 180 markets and runs operations in 75 countries. We now have an excellent clinical trial document management position opportunity to join our Clinical team for 12 month fixed term contract in Frenchs Forest, Sydney. The position while being based out of Australia will service CTDM activities across Asia Pacific as needed . In this role your key objectives will be to coordinate delivery, collection, and review of trial documents to and from investigator sites and the GCSM organization and ensure clinical site documentation is done in accordance with Alcon Standard Operating Procedures (SOPs), Good Clinical Practice (ICH-GCP), Good Business Practices and applicable regulatory requirements. Your primary accountabilities will include: • Coordinate delivery and collection of trial documents to and from investigator sites/GCSMs; including facilitating IRB/IEC submissions. • Ensureaccuracy and quality documents included in the site initiation packets • Enter and maintain site information and document tracking in current clinical systems. • Ensure trial documentation is well organized, filed appropriately, and is available and current for the study team. • May specialize in preparation of SIP, budgets/contracts, or in other specialized functions as needed. • Follows applicable work processes, SOPs, communication plans, etc. Ensuretimely elevation of issues with sites related to preparation/collection of trial documents, initiation packets, site budgets and contracts, or other relevant documentation. May provide documents to other GC&RA functions as needed. • Work under direction of a remote lead/manager. Work may be reviewed for soundess of judgment and overall adequacy and accuracy.
Minimum requirements	• University degree in life sciences • Minimum of 1-2 years of applicable experience within clinical research and/or business administration Knowledge of applicable guidelines, including GCP guidelines, ICH and FDA regulations • English and other major languages preferred • Full Australian work rights