Project Manager Management
Resume:
Kendle International Inc. Wilmington, NC USA (formerly known as Charles River)
Clinical Data Management, Assistant Project Manager
• Management on multiple (3-5) Clinical, DM standalone and Registries/Late Phase protocols with oversight from CDM management.
• Ability to create or have oversight responsibility for CRF design in accordance to the protocol and standards established by Kendle and its sponsor clients.
• Ability to develop project specific data management plans (DMPs) and other related documentation.
• Reviews reports, listings, and other documents generated in data management for distribution to sponsor, investigators and their study support staff.
• Ability to design, validate, implement and maintain projects in any clinical data management system used by Kendle.
• Serves as the primary Kendle project contact for data management with clinical, and sponsor. Assists in monitoring study costs, including estimating time, cost and resources required for a project.
• Assists in staffing assignments for assigned projects, ensuring that the project is sufficiently staffed with qualified personnel and specific project requirements are met.
• Provides functional management and supervision of specific projects and project personnel, as well as conducting timely and through evaluation of work performance of all direct report personnel.
• Assists in providing in house instruction as part of technical career development for Clinical Data Associates including assisting in training progress assessment, and facilitating technical development training for direct report employees.
• Assists in the sourcing, interviewing, and hiring of contract and permanent clinical data management staff.
• Represents Clinical Data Management and Kendle in client meetings and presentations.
• Maintains a professional working relationship with sponsor, collaborating associate, vendor and subcontract personnel. Responds to employee requests and questions in a professional, timely, and thorough manner.
• Understands and comply with all Kendle policies and procedures, including company SOPs. Maintains compliance with Kendle's policies and procedures including security, safety, and general work rules. Keeps abreast of GCP guidelines, GMP regulations and Kendle's SOPs related to data management and interactions in other project assigned Kendle divisions.
Mar 2003 - Dec 2003
Kendle International Inc. Wilmington, NC USA (formerly known as Inveresk)
Senior Clinical Data Associate
• Participation in the development and execution of the data management functions of clinical trials (2-3) with limited delegated authority.
• Execute data management functions in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs) set forth by the company and its sponsor clients.
• Design, validate, implement and maintain projects in any clinical data management system used by the company.
• Conduct pre-entry edits on CRFs forwarded to the company.
• Design CRF in accordance to the protocol and standards established by the company and its sponsor clients.
• Generate DCFs or forward DCFs generated at any point during the CRF processing to Data Management Project Manager or Clinical Project Manager as appropriate.
• Oversight responsibility for CRF and supporting documentation and reports on a specific project while in data management.
• Conduct quality assurance, validity, quality control processes and data entry program testing.
• Primary author of the project edit specifications for processing the CRF, consulting and incorporating the requirements of sponsor, programmer, statistician, and clinical divisions.
• Serve as the primary project contact for data management with clinical and sponsor, as appropriate.
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Jul 2001 - Mar 2002
Kendle International Inc. Wilmington, NC USA (formerly known as PharmaResearch)
Clinical Data Associate II
• Participation in the execution of the data management functions of clinical trials (1-3) with limited delegated authority.
• Execute data management functions in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs) set forth by the company and its sponsor clients.
• Design, validate, implement and maintain projects in any clinical data management system used by the company.
• Conduct pre-entry review on CRF pages forwarded to the company.
• Design CRFs in accordance to the protocol and standards established by the company and its sponsor clients.
• Generate DCFs or forwards DCFs generated at any point during the CRF processing in data management to the Data Management Project Manager.
• Responsibility to execute the compare/repair process, quality assurance, validity and quality control processes, and data entry program testing.
• Primary author of the project edit specifications for processing the CRF, consulting and incorporating the requirements of sponsor, programmer, statisticians, and clinical divisions.
May 2000 - Jul 2001
Kendle International Inc. Wilmington, NC USA (formerly known as PharmaResearch)
Clinical Data Associate I
• Participation in the execution of the data management functions of clinical trials (1-3) in accordance with the Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs) set forth by the company and its sponsor clients.
• Design, validate, implement and maintain projects in any clinical data management system used by the company. Conduct pre-entry review on CRF pages forwarded to the company.
• Generate Data Clarification Forms and forwards DCFs generated at any point during the CRF processing in data management to the Data Management Project Manager.
• Conduct the compare/repair process, quality assurance, validity and quality control processes, and data entry program testing.
Jul 1995 - Feb 2000
Carolina Eye Associates Wilmington, NC USA
COA/Laser Vision Coordinator/Marketing Assistant
• Multi-tasked position responsible for marketing, physician and patient scheduling as well as direct technical contact with patients.
• Marketing duties included management of all multi-media outlets. Responsible for coordinating program run schedules, creating copy, designing advertisements and layouts.
• Monitored all marketing efforts to ensure results and maintained marketing budget.
• Scheduling duties included initial phone inquiries, distribution of promotional information, briefing patients on procedures and financing. Also creating templates for physician's schedules, as well as maintaining, updating and distribution of schedules.
• Certified Ophthalmic Assistant duties included vision screening, applanation tonometry, slit lamp exams, pupil dilation, topography, auto-refractor, auto-lensometer, refractometry, excimer laser technician for VISX and SUMMIT lasers, chart documentation/transcribing and assisting physician with minor office procedures and exams.
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Wilmington Health Associates Wilmington, NC USA
Medical Assistant/Appointment Secretary
THERAPEUTIC EXPERIENCES
Cardiovascular
• Cardiovascular - Pulmonary Arterial Hypertension
Dental
• Dental - Post Surgical Dental Pain
Dermatology
Jul 1994 - Jul 1995
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• Dermatology - Bandage Effectiveness Wound Healing
• Dermatology - Chronic Plaque Psoriasis
• Dermatology - Facial Acne
• Dermatology - Male Sexual Dysfunction
Hematology
• Hematology - Human Immunodeficiency Virus Infection
Ophthalmology
• Ophthalmology - Age-Related Macular Degeneration
• Ophthalmology - Cataract Surgery
• Ophthalmology - Cataracts
• Ophthalmology - Glaucoma
• Ophthalmology - Local Anesthesia
• Ophthalmology - Macular Degeneration
• Ophthalmology - Ocular Hypertension
• Ophthalmology - Open Angle Glaucoma
• Ophthalmology- Retinitis Pigmentosa
• Ophthalmology- Laser Vision Correction
• Duties included patient work-up, assisting physician, answering telephone, scheduling appointments, ordering/maintaining supplies and general office duties.
Jul 1993 - Jul 1994
Eye Associates of Wilmington Wilmington, NC USA
Certified Ophthalmic Assistant
• Duties included performing patient visual exam, tonopen applanation tonometry, topography, refractometry, answering telephones, ordering/maintaining contact lenses and diagnostic drug supplies, assisting physician with refractive and general office surgery, scheduling patients for hospital surgery, general office duties and maintenance of equipment.
Jun 1991 - Jul 1993
Doctor's Vision Center-Wilmington, NC USA
Registered Ophthalmic Assistant/Contact Lens Specialist
• Duties included patient visual screening, puff tonometry, performing visual field test, answering telephones, ordering/maintaining contact lens supply and diagnostic drug supplies, appointment scheduling, general office duties, assisting physician and maintenance of equipment.
Respiratory
• Respiratory - Adult Asthma
• Respiratory - Chronic Bronchitis
• Respiratory - Congestive Heart Failure
Skeletal Diseases
• Skeletal Diseases - Dupuytrens Disease
ADDITIONAL EXPERIENCES
• CDISC Experience
• Paper and eCRF Design for NA projects
• EDC-TrialMaster
• TrialBase, ClinTrial, eforms Experience
•
EDUCATION
2009
Society for Clinical Data Management - United States
Certified Clinical Data Manage
Miller-Motte Business College –Wilmington, NC
1994
JACHPO - United States
Certified Ophthalmic Assastant
TrialMaster elearning Certificate
1992
National Optometric Registry - United States
Registered Optometric Assistant
1988
Laney High School - United States
High School Diploma College Honors and Prep Courses
Sept 2008-current
PROFESSIONAL CERTIFICATIONS & LICENSURES
Aug 2008
Certified Clinical Data Manager
Feb 2000
Laser Refractive Practice Marketing & Management
Apr 1999
System Operator Certification for VISX Star Excimer Laser
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BIOGRAPHY OVERVIEW
I joined the CRO industry in 2000 as CDA I and quickly climbed the ladder to a management position. I was promoted to CDA II in 2001. In 2002 I was promoted to Senior CDM and managed various types of multi-center trials conducted throughout North America, South America and Europe. I was promoted to CDM Assistant Project Manager in 2004 and in 2007 I was promoted to Clinical Data Manager.
Additional experience and expertise includes authoring CDM start-up documents, Designing paper CRFs, eCRFs and validation guidelines. I have also been involved in team staffing and training, conducting candidate interviews, implementing consistent guidelines of data provided by the sites, centralized and local laboratories for processing and transfers of study data.
My CDM experience allowed me to served as Project Manager on a variety of studies, including two Phase I Ophthalmology studies, a Phase II Ophthalmology study, a large Phase III pivotal study, four concurrent Phase III global sister studies, a Phase III Follow-Up to the previous mentioned studies, two Phase IIs sister studies and multiple Registries studies. In 2008 I successfully accomplished the title of Certified Clinical Data Manager through the Society for Clinical Data Management.
As noted, I have managed multiple studies simultaneously with international team members, trained and mentored colleagues, and maintained budgets, provided forcasting of budget and time and ensured timelines are met on time and within budget.
I currently manage a Phase III pivotal study; Phase 2b and Phase 1 EU Ophthalmology studies; a global, Phase III, EDC megatrial for a high profile sponsor; close out 2 Phase 2a sister studies, start up of a government funded study and a sister pregnancy registry.
I continually devote my time, talent and energy to ensure that all CDM activities from study start-up to archival are completed according to quality standards, SOPs, ICH guidelines and Good Clinical Practice.
Prior to Kendle, I served 10 years in clinical Ophthalmology as a Certified Ophthalmic Assistant, 2 years of clinical Optometry as a Registered Optometric Technician and several years of clinical Internal Medicine as a Medical Assistant. I also have diverse therapeutic experience including Dermatology, Respiratory, Virology/Infectious Disease, Pain Management/Analgesia, Cardiology, Cholesterol and Dupuytren's Contracture with all study Phases I-IV, Late Phase and Pregnancy Registries.
As a Certified Clinical Data Manager (CCDM), with nearly 11 years in the industry and over 8 years in a management position I feel that I would bring unprecedented talent and expertise to your company. I would like to expand my knowledge in other therapeutic areas as well as provide my proven talent on any studies pertaining to my therapeutic experience.
I look forward to talking with you at your earliest convenience to discuss a position that will provide opportunity to grow and utilize my experience.
Kind Regards,
Tania Sholar
bkjtqj@r.postjobfree.com
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