Candace Wright

About Candace Wright

I am a detail-oriented Clinical Data Management professional with a little over 25 years of experience across Phase I-IV studies in multiple therapeutic areas with expertise in Infectious Disease, COVID-19, GI, Central Nervous System (CNS)/ Psychiatry / Neurology, Oncology, Respiratory, Cardiovascular, etc. Proven success in investigation and management of drug safety, development, analysis, and evaluation of toxicity data, and organization of disparate research data. Systematic leader focused on overall accuracy in the administration with demonstrated history of working in the pharmaceuticals industry providing solid core and comprehensive data management expertise to data management team in order to provide efficient, quality data management products that meet customer needs.Well Versed in many areas of Clinical Data Management which includes:• 25 years of CRO/Pharmaceuticals (Data Management) experience in several roles• 12 years of performing as a Clinical Data Manager (CDM)• Infectious Disease – HIV, Hepatitis, Severe Diarrhea (C-Diff), and COVID-19• CNS / Psychiatry / Neurology – ADHD (multiple studies), Bipolar Disorder, Depression, Schizophrenia, Insomnia, Blepharospasm, Cervical Dystonia, Restless Leg Syndrome, Low Back Pain, Parkinson’s Disease, Diabetic Neuropathy, Major Depressive Disorder (multiple studies), Opioid Use Disorder, and Sleep Deprivation.• Respiratory – Bronchitis and Asthma • Internal Medicine – Constipation- Cardiovascular - Hypertension • Medical Devices – Spinal Fusions and Degenerative Back/Disc Disease • Pediatrics – Colonoscopy Prep and GERD • Gastrointestinal – Colonoscopy Prep (3 Studies). Oncology - Metastatic Pancreatic Cancer, Ovarian Cancer, and Solid Tumors (3 Studies)Skilled: Electronic Data Capture (EDC), MedDRA, WHODrug, Data Cleaning, Data Validation, Medical Devices, Discrepancy Review (Merge eClinical, Inform 6.0, DataLabs, OC-RDC, Rave (Classic), Zelta, Rave (EDC), and eSource: CMED, Verily, and DSG/eCaseLink). Issue valid queries to sites, Manual data listing review/data cleaning/vendor reconciliations/clinical data manager tasks as a Clinical Data Manager on 3 studies including but not limited to: client interface, managing internal teams, setting up databases, metrics sent to clients weekly, working with programmer by creating listing specifications & vendor reconciliations & edit check testing & presentations to clients every week, DSMB (Data Safety Monitoring Board) IA (Interim Analysis), FDA Submission, GCP, etc.

Experience

1. Senior Clinical Data Manager

   Worldwide Clinical Trials

   Dec 2022 — Present · US

   Senior Clinical Data Manager for Central Nervous System (CNS)/ Psychiatry / Neurology studies (1 - Phase 3 “Opioid Use Disorder” study (Rave EDC) & 1 - Phase 2 “Major Depressive Disorder (MDD)” study (Zelta EDC)

Education

• Wake Technical Community College

  Associate of Arts (A.A.), Psychology - Many Credits Obtained

  1995 — 1998

Skills

• Inform
• Electronic Data Capture (Edc)
• Oracle Discoverer
• Edc
• Therapeutic Areas
• Ctms
• User Acceptance Testing
• Medical Devices
• Clinical Research
• Sas
• CRO Management
• Data Validation
• Crfs
• Cdisc Standards
• Pharmaceutical Industry
• Sop
• Clinical Trials
• Phase Forward Inform
• Oncology
• Protocol
• U.s. Title 21 Cfr Part 11 Regulation
• Data Cleaning
• Oc Rdc
• CRO
• Ecrf
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Cdisc
• Gcp
• Standard Operating Procedure (Sop)
• Meddra
• Crf Design
• Good Clinical Practice (Gcp)
• Clinical Data
• Data Management
• Ich-Gcp
• Infectious Diseases
• Clinical Development
• Medidata
• Clinical Data Management