Contact information

Michael M. Naccarat

4611 Nelm Street
Hyderabad – 22102

Career objective

Looking for a challenging position of the Clinical Data Manager in the reputed company with a view to use my wide experience for the benefit of the organization.

Skills

• I have good time management and organizational skills.
• I possess good Oral/written presentation skills underpinned by strong analytical skills.
• I possess an exceptional history of good client service.
• I can competently use Microsoft office suite: Word, Excel, PowerPoint, Intranet, Access, Internet, and Visio and e-mail system.

Career Achievements

• Recently deployed iPM Choose and Book integrated system replacing an already existent Proxima Directly bookable Choose and Book system that was not non-integrated with Patient Administration System
• Worked through technical hurdles of replacement system with suppliers co-ordinated testing creation of Directory of Service and clinic set-up.
• Liaised directly with suppliers and Connecting for Health to integrate iPM Choose and Book
• Project manage the training delivery for over 1200 users across 8 sites within the Trust
• Lead a team of ten trainers responsible for production of all end-user role based training materials
• Head up a large team floorwalkers responding to support issues as they arise during go-live. Report to Trust on progress
• Responsible for developing and deploying a training needs analysis to evaluate the skills of the workforce and further to implement a timetable for the scheduling of end users on to role based training courses
• Provide product demonstrations for major stakeholders and management throughout the Trust
• Ensure that Trainers have an excellent understanding of the Trust systems

Experience

Clinical Data Associate

Kendle Internationals Inc., Ahmedabad, India

2000 to Present.

• To act as a study lead and assist the team to perform their roles and responsibilities.
• To develop and maintain Data management plan and Data validation plan.
• To perform study start up activities viz.: CRF designing, Database testing and Validation procedure testing.
• To perform discrepancy management on both paper studies and electronic data capture (EDC) studies.
• To perform reconciliation of similar data between multiple data sources.
• To generate and/or review listings to check accuracy and completeness of clinical data.
• To perform internal CDM QC audits of the clinical database against the CRFs including query results for paper studies.
• To freeze eCRF data and perform lock of subject information.
• To provide support to users of IVR/IWR. Manage issues until resolution.
• To Work with the IVR/IWR Project lead to determine the resolution of a particular issue when required.

Job Title: Clinical Trials Data Manager

For the IMPORT Trial, LTD

1997 to 2000

• A Phase III trial using dose intensity modulation to test partial volume radiotherapy and dose escalation after conversation surgery for early stage breast cancer in women at low and high risk.
• ·Reports / Trial Documentation
• Preparing reports for the IMPORT Trial Management and steering committee Groups
• Designing and creating quarterly IMPORT Newsletter
• Designing and Creating CRFs for IMPORT
• Maintaining the in house database for tracking CRFs
• Creating a number of databases for IMPORT, including biological samples databases for tracking specimen.

Education

• 1995 -1996 University of East London
• MSc Toxicology (ongoing) Taught modules completed.Dissertation submission Sep 2010.

• 1990-1994 University of Hertfordshire, UK
• BSc (Hons) Applied Biology (Physiology/Pharmacology)

• 1988-1990 Northfields Upper School Sixth Form College, Dunstable, UK
• A Level Mathematics (Statistics)

• 1985-1988 Northfields Upper School, Dunstable, UK
• Level Mathematics, AO level Mathematics, AS level Mathematics.
• GCSE English Language, English Literature, Art, French, Physics, Chemistry, Biology

References
Floyd P. Olivier
Manager
Wap Company.
Floyd_oliver@gmail.com

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