Nathifa Young

Experience

• 

  DADE BEHRING,

  Jan 2003 - Jan 2005

  Inside Sales Supervisor

  A laboratory diagnostic leader that offers a wide range of products, systems and services designed to meet the day-to-day needs of clinical laboratories. Inside Sales Supervisor, West Region (2004-2005)•Managed a team of 11-13 Inside Sales Generalists daily sales goals•Helped establish annual sales objectives for the team working closely with Marketing & Customer Management•Drove method penetration, instrument lead generation, Evaluation Kit Revenue, and customer retention goals •Partnered with Field Sales Representatives and Regional Managers to resolve account issues•Responsible for sales quota and all sales objectives for the Region•Coached and mentored employees by providing regular feedback, identifying department training, and development needsInside Sales Representative, Generalist (2003-2004)•Delivered sales revenue growth via teamwork and commitment to meeting objectives•Accomplished method penetration by selling additional consumables (all product lines) to customers during frequent follow-up contacts to promoted platform consolidation•Served as a liaison between the customer and the Field Sales Representative to provide exceptional service•Promoted and reinforced the value of Dade Behring products•Accomplished sales growth by supporting marketing initiatives•Responsible for sales quota and all sales objectives•Met Evaluation Kit Revenue at 254.94% for 2003 Show less

• 

  SYSMEX AMERICA INC

  Jan 2005 - Jan 2006

  Technical Resource Specialist

  A leading international manufacturer of diagnostic hematology systems for medical laboratories worldwide.•Established and monitored daily review of QC material and maintenance logs for each instrument in the Assay Lab area to achieve accurate assay values for customers and field personnel.•Tested blood products or reagents in order to verify conformity to specification as well as assisted in preparation of product inspection reports to determine quality of material.•Assisted in performing reference calibration methods as scheduled and as required. •Assisted with the maintenance and repair of instrumentation •Performed the NCCL approved reference methods during whole blood calibrations•Performed and reviewed CAP and New York State Surveys•Performed phlebotomy as needed Show less

• 

  FENWAL, INCORPORATED,

  May 2006 - Aug 2008

  Clinical Research Associate II

  Divested from Transfusion Therapies, Baxter Healthcare Corporation. Fenwal is one of the world’s largest suppliers of products and services for the transfusion medicine industry. Clinical Research Associate IIJob duties and description similar to the Clinical Research Associate position at Abbott Laboratories in Abbott Park, IL

• 

  Abbott

  Sept 2008 - Oct 2014

  A global, broad-based health care company devoted to discovering new medicines, new technologies and new ways to manage health. Clinical Research Associate •Executes all aspects of internal and external clinical trials including development of investigational plan, pre-site qualification, site initiation, monitoring, site close-out, control of experimental articles, and development of final report.•Assists senior staff in planning study conduct, designing Case Report Forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, selection and training of new study investigators and writing and assembling submissions.•Monitor to ensure trials are conducted, recorded and reported according to the protocol, standard operating procedures, good clinical practice and applicable regulatory requirements, timely enrollment of patients, and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification, and completion of study summary.•Assists clinical sites with IRB/IEC submissions and ensure collection of required essential documents for start-up and throughout conduct of study.•Makes regular contact with the investigators or other site staff during the course of the study to ensure that all is proceeding according to agreed protocols and time schedules, and that data is being recorded accurately and returned to the sponsor in a timely fashion.•Possesses a good knowledge of Good Clinical Practice and local regulations (e.g. in the United States, the code of federal regulations also known as 21 CFRs)•Prepares study budgets, research agreements, and help negotiate investigator budget.•Ensures timely completion of Food and Drug Administration and European regulatory applications.•Maintains effective communication with other members of the clinical team and management. Show less

  • Sr. Clinical Research Associate

    Apr 2013 - Oct 2014

  • Clinical Research Associate

    Sept 2008 - Apr 2013
• 

  Sysmex America, Inc.

  Oct 2014 - Aug 2021

  Clinical Affairs Manager

  •Manage implementation of clinical research strategies to meet business goals and objectives with the primary focus in the business.•Address the needs for clinical evidence and marketing claims for new and existing products in collaboration with Business and Development.•Participate in data analysis, interpretation and synthesis, instructions for Use development, and Risk Management activities.•Maintain responsibility for successful execution of clinical studies in compliance with investigational plans and all applicable regulations.•Provide input and/or determine subject recruitment strategies, operational feasibility and implementation of study/program objectives.•Author, review and revise Clinical Operations Standard Operating Procedures (SOPs).•Develop, implement and maintain standards across clinical studies within a program including, but not limited to new hire training for CRAs, tools, templates and CRO hire, supervising and training personnel (CRA and/or CRO) and taking ownership of the quality of assigned clinical programs and deliverables.•Set annual goals, objectives and development plans for staff, provide performance feedback and conduct performance evaluations.•Prepare clinical protocols, data collection tools and ancillary documents.•Select and manage qualified investigational sites and investigator qualification and training.•Support regulatory submissions and participate in the development of project management plans and data management plans, statistical analysis plans.•Author clinical study reports for the clinical studies.•Participate in preparation of annual and ad-hoc reports and ensure integrity of data submissions to IRBs and/or regulatory authorities.•Review and integrate statistical output from clinical trials, and determine the appropriate evaluation, interpretation, and presentation of data.•Review study proposals submitted by prospective investigators. Show less

• 

  Abbott

  Feb 2017 - now

  • Director Clinical Affairs

    Feb 2023 - now

  • Associate Director Clinical Operations

    Feb 2017 - Feb 2023