Clinical Data Manager II @ Therapeutic Area: Infectious Diseases • Acts as the lead data manager for one or more projects and also provides support to another lead data manager on one or more projects. • Independently and efficiently oversees and/or performs, with quality, all data management cleaning activities in accordance with the Data Validation Manual (DVM) and/or client documentation within an assigned study. • Mentors junior level staff on all associated tasks within a study. • Liaise with the sponsor and other functional groups as required and communicates with management regarding all data management activities within studies. • Designates tasks appropriately within the team, ensuring all work conducted is completed to the acceptable quality in accordance with global Standard Operating Procedure (SOPs) and the DVM. • Represents Clinical Data Management at internal and external meetings and presentations including business development activities • Responsible for administrative oversight and provides financial oversight of designated projects • Acts as a Project Manager on a DM standalone study/coordinates multiple projects for a Franchise or Alliance as required. • Leads multiple, high volume/highly complex studies From August 2015 to Present (5 months) Clinical Data Manager @ Therapeutic Area: Nutritional Products (Pediatrics), Medical Device (Renal) • Oversaw 4 clinical trials (1 nutritional, 3 device) including start-up, maintenance, and close-out activities • Participated in study team meetings on a weekly or bi-weekly basis to discuss upcoming milestones, changes to the clinical database, problematic data, etc • Was responsible for creating and/or maintaining eCRFs, Completion Guidelines, Data Management Plan, Edit Specifications, etc • Performed UAT testing • Coded Adverse Events, Medications, and Medical Histories/Surgeries on an ongoing basis using WHODrug and MedDRA dictionaries • Served as liaison between multiple groups (clinical, statistics, medical monitors, safety) • Trained junior staff on EDC systems and Data Management processes From January 2014 to July 2015 (1 year 7 months) Clinical Data Manager (Contractor) @ Therapeutic Area: Neurology (Alzheimer's), Pain (Diabetic), Women's Health (Endometriosis) • Led study team meetings on a regular basis for multiple Phase I, II, and III studies to discuss upcoming milestones, changes to the clinical database, problematic data, etc • Responsible for maintaining and updating eCRF Completion Guidelines, Data Management Plan, validations, specifications, etc. • Provided accurate data acquisition and furnishes accurate and well-documented study databases to the statistical and clinical teams • Maintained study document binder • Monitored and reconciled external vendor data • Served as liaison between multiple groups (data entry, clinical, statistics, safety, pharmacovigilance, and coding) • Performed all start-up activities as well as conduct and close • Initiated the purchase of CRFs, diaries, and related documents from clinical protocols • Prepared the study database dictionary • Developed quality assurance database checks From June 2012 to December 2013 (1 year 7 months) Clinical Data Scientist (Contractor) @ Therapeutic Area: Oncology (Liver and Renal) • Maintained and updated eCRF Completion Guidelines, Data Management Plan, etc. • Prepared, distributed, and presented data management metrics for bi-weekly meetings • Issued data queries • Created and tested UAT scripts • Performed eCRF data validation through listings and reports to ensure data integrity and quality • Assisted in the development of data validation specifications • SAE Reconciliation • Participated in QC of data as needed • Prepared presentations for CRA training sessions regarding data entry • Effectively communicated w/colleagues and customers to maintain a consistent approach in handling the work From August 2011 to February 2012 (7 months) Clinical Data Coordinator @ Therapeutic Area: Oncology (Multiple Myeloma) • Reviewed clinical trial data in accordance with Data Management Plans to identify erroneous, missing, incomplete, or implausible data • Ran special listings and reconciliation reports to support the review of clinical trial data • Generated, resolved and tracked queries to address problematic data identified during data review • Assisted with the review of clinical data by patient, site, and country to identify data trends (patient safety, compliance, etc.), or inconsistencies that required further investigation • Assisted in UAT testing From 2009 to 2010 (1 year) Clinical Data Coordinator @ Therapeutic Area: Oncology (Gastric, Pancreatic, Breast), Urology (Overactive Bladder) • Performed data review of paper and electronic CRFs for completeness, accuracy, and consistency for 3 Phase I and Phase III studies • Generated and resolved data queries • Updated data in databases based on resolved queries • Performed data listing review • Assisted in data audits (QA/QC) From July 2007 to December 2008 (1 year 6 months) Clinical Data Specialist (Contractor) @ Therapeutic Area: Gastroenterology (GERD, Erosive Esophagitis), Women’s Health (Endometriosis, Uterine Fibroids) • Performed QC checks of external data received (diaries and labs) for 9 Phase I and III gastroesophageal and gynecological studies • Issued queries for discrepant or missing data in OC and RAVE • Scanned and indexed CRFs and DCFs into document management system • Performed lab reconciliation between external data sources and internal databases • Trained new employees on entering UAT data into Medidata Rave • Recipient of the ‘Circle of Excellence Award’, Manpower Professional, July 2006, January 2007 & May 2007 From November 2005 to July 2007 (1 year 9 months) Clinical Operations Intern (Summer & winter breaks only) @ • Prepared PowerPoint slides and assembled study binders for trainings, investigator meetings, and other presentations • Filed blank and annotated CRFs, protocols, 1572’s, investigator/other personnel CV’s, client correspondence, and other related study documents in the Trial Master File for multiple studies • Prepared study documentation for archival and the FDA • Copied and distributed protocols for Clinical Operations, Data Management, and Regulatory Affairs • Distributed mail throughout the clinical team From June 2000 to August 2002 (2 years 3 months)

Bachelor of Applied Science (B.A.Sc.), Public Health @ Northern Illinois University From 1999 to 2004 Danielle Blount is skilled in: Microsoft Word, PowerPoint, Customer Service, English, Windows, Research, Outlook, Teaching, Editing, Data Analysis, Oracle Clinical, EDC, CRF design, Clinical Data Management, Clinical Development