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We are currently seeking candidates with impeccable multitasking skills and ability to work under pressure with a smile on their face!!
DSS Consulting Inc., was founded in April 1999 and been recognized as the second-fastest growing privately held company in the Indianapolis-area, with growth of over 600%, by the Indianapolis Business Journal (IBJ, September). We continue to enjoy tremendous success with its corporate partners, becoming one of the fastest growing, minority owned companies in the state. The company has experienced more than 100% growth each year since its foundation, and it currently holds the ranking as one of the Top 5 largest MBE staffing firms in Indiana (source: IBJ, August).
This individual in this position will support the Clinical Trial Materials Management (CTMM) department and:
· Support the program teams, product teams, and affiliate customers by providing total study drug management and IVRS services.
· Manage the study drug inventory for ongoing studies by utilizing set parameters, spreadsheets, and other tools to optimize the use of the study drug; with the goal of eliminating “out-of-drug calls” due to avoidable circumstances.
· Collaborate with the Clinical Trial Supply Coordination (CTSC) associate during the planning, ordering, and execution phase of the trial.
· Work in Excel spreadsheets and work with data in the spreadsheets (i.e. running/creating metrics, setting up spreadsheets, working with large spreadsheets, complex inventories, etc.)
· Must be comfortable with math, as this is required and must be demonstrated in previous work experiences or through education.
· Must have strong attention to detail.
· Ability to demonstrate that they can follow instructions.
· Must be able to work within a team environment and must be able to provide evidence of that.
Typical responsibilities include:
· Inventory management- Participate in process meetings as appropriate.
· Provide inventory management expertise for setup processes and meetings.
· Review and understand applicable sections of study protocols.
· Coordinate ancillary supplies, as necessary.
· Coordinate distribution of training materials, as necessary.
· Create and maintain inventory tracking tools as appropriate.
· Update tools, as necessary, based on changes from the study plan.
· Review inventory and confirm shipments as needed.
· Direct shipments-Collaborate with logistics assistants to understand distribution plan and requisite lead times.
· Initiate shipments of material and ancillary supplies to US sites.
· Direct shipments by global affiliates and distribution sites.
· Ensure site/affiliate regulatory readiness prior to shipping and obtain appropriate documentation.
· Process Data Collection information from investigator sites and review for accuracy and completeness.
· Communicate with Manufacturing and Technical Services representatives for reports of urgency.
· Communicate final disposition of affected material to investigator sites.
· Other study support activities as needed
· Review worksheets and fax re-order forms if applicable.
· Assist with ATM/startup meeting presentations.
· Escalate inventory, shipping, and temperature excursion issues as appropriate to CTSC Associates and Clinical Trial Project Managers (CTPMs).
· File appropriate documentation (binder, LAN, Lotus Notes).
· Prepare documentation for archival after the study ends.
· Process improvement-Proactively identify ways to improve day-to-day activities and practices and actively communicate the opportunities to peers and leadership.
· Participate in and/or support the implementation of local or divisional six sigma or other process improvement initiatives.
· Stay abreast of cGMPs, GCPs, and other regulatory requirements to ensure activities stay in alignment with them. Use common sense and question poor business decisions. | 
