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Clinical Data Manager/Clinical Coder Resume


Contact Candidate


Name:

Elani

Location:

South Africa-Free State-Bloemfontein

Experience:

Willing to Relocate:

Willing to Travel:

Most Recent Job Title:

Clinical Data Manager/Clinical Coder

Personal Website:

Objective:

I have been employed at a CRO (Clinical Research Organization) since the 1st of September, 2007 in Bloemfontein. By having to establish daily operational bases for projects as a primary clinical data manager and providing the direction to a team in order to insure the progress and deadlines are met, has allowed my skills in teamwork and leadership to be developed.

Teamwork is a skill I know is necessary for organizational cohesiveness. Working as part of a team has helped to expand my leadership skills and has allowed me to spontaneously interact with ethnic diverse populations and all age groups.

Accepting challenges is the foundation of my life experiences and something I do with confidence. You will find me a totally committed individual with pride in being direct, spontaneous and communicative. I can maintain records, perform numerical calculations with accuracy and I need little direction to complete assigned tasks. These are the qualities that make an excellent medical sales representative.

Resume Text:

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based on validation specification.
Coordinate and manage Data Management services for Phase I-IV clinical trials across multiple therapeutic areas in both paper and EDC environments. Responsibilities include project planning and initiation, study set-up, ongoing processing and database lock.
Representing PAREXEL at Bid Defenses, Sponsor Kick-offs, and Investigator Meetings. Review investigative protocols, review/Edit CRFs and mock eCRFs. Design CRF Completion Guidelines, coordinate database QC and UAT. Create and test Data Validation Specifications. Perform data validation and discrepancy review. Generate and integrate queries. Perform coding. Manage SAE, lab and other electronic data reconciliation processes. Monitor project progress and generate standard metric reports. Participate in internal and client team meetings. Demonstrate knowledge of industry standards and compliance with Good Clinical Practice (GCP), ICH, 21CFR and other regulatory requirements.
Adhere to quality, timeline and productivity requirements. Propose new approaches, methods or technologies to gain efficiencies and exceed client expectations. Carry out all functions to the highest standards of quality and efficiency representing the best interests of PAREXEL, and the client at all times.


2. Teacher – Primary & Secondary School:
Grey College High School, SA 08/2006 – 11/2006
*Teaching five subjects to the 8th Grade. The subjects consisted of:
English as primary language
Geography
History
Arts and Culture
Life Orientation

*Teaching technology to Grades 4 through 7 05/2007 – 08/2007


3. Biology Laboratory Assistant 05/2004 – 03/2006
Bucks County Communtiy College, USA
*Preparation of all slides
*Inoculation and culturing of bacteria
*Preparation of all petri dishes
*Preparation of all agar examples
*Validation and processing of analytical data
*In charge of setting up lab exercises
*Managing lab exercises
*Ordering and taking stock
*Managing the cleaning of all 6 labs
*Ensuring all organic and inorganic chemicals are properly handled and disposed of
*Properly disposing of all dissected animals
*Managing the well-being and care of all living creatures used in experiments


4. Nanny/Au Pair/Overseer: 01/1997 – 06/2006
SA and USA
*Preparing dinner for the entire family
*Preparation of breakfast and lunch for the children
*Assisting them in all homework and school projects
*Volunteering at school plays, extracurricular activities and music concerts
*Chaperon on field trips
*Helping the children with the various instruments they play (piano, violin, electrical guitar and drums)
*Driving children to and from extracurricular activities


5. Accountant Trainée: 02/2002 - 06/2002
Afrisec Procurement, SA
*Completing orders on computer, mainly using Excel
*In charge of installing and switching company over to a new filing system
*Managing and assisting 2 other trainees
*Proofreading/Edit trainees documents
*Ensuring orders are delivered in a timely fashion
*Maintaining all records of previous filing system
*Maintaining customer files
*Setting up client mailing list and managing it
*Assisting and organizing marketing strategies and activities
*General administrative support/assistance
*Answering the phone & dealing directly with clients
*Searching for and contacting new distributors
*Managing companies’ administration


6. Waitress/Hostess: 01/2002 - 06/2002
Fauresmith, SA
*Taking orders from clients
*In charge of cashing up at the end of the night
*Somewhat involved in meal preparation
*Managing cleanliness of restaurant
*Greeting and assisting clients
*Managing functions/receptions
*Informing guests about the history of Fauresmith
*Managing restaurant’s promotion strategies
*Welcoming foreign guests into a truly African vibe restaurant and sharing our culture with them


7. Sales Assistant: 11/2001 - 12/2001
Jagersfontein, SA
*Managing sales
*Taking stock
*Unpacking stock
*Assisting customers
*In charge of the hygiene of store

Education:
Tertiary Education
1. Enrolled at UOFS, 2008, in Human Molecular Biology, Honours (B.Med.Sc)

2. Bucks County Community College, Newtown, U.S.A, Associate Degree in Biology/Pre-Medicine (Distinction) (Equivalent of a B.Sc degree in Biology at UOFS)

3. Manhattanville College, Valhalla, U.S.A, Journalism Diploma (Distinction)

4. Manhattanville College, Valhalla, U.S.A, . Diploma in New York Immigration History (Distinction)

Secondary Education
Sentraal High School, Bloemfontein, S.A

Language Skills:
Afrikaans: Fluent
English: Fluent
Sesotho: Beginner
Spanish: Beginner
French: Beginner

Professional Associations:
Member of Phi Theta Kappa International Honour Society
Skills:
Computer literate: Microsoft Word, Excel, Access, Power Point, Outlook, NetMeeting, LiveLink, Adobe, WinZip
Software, CRO Industry: MART, SAS UNIX, LION, TIGER, PUMA, Clintrail (CT43, CT44), PXLTools, PLSQL Developer, Reflections, TAIPAN
Organic Chemistry identification procedures, e.g.: Liquid and gas chromatography, Thin Layer
Chromatography,
SPECTROSCOPY: NMR, IR, MS, UV
Purification techniques: recristallisation, distillation, etc.
Strong administrative skills
Good interpersonal, team and communication skills
Excellent knowledge of the English language
Systematic approach to problem solving
A go-getter with initiative
Highly responsible
Meticulous regarding detail
Able to manage multiple and varied tasks
I enjoy working as a team, but I’m not shy to step up and take the lead


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