Danielle Blount Email & Phone Number

Chicago, Il, Us

Redwood City, California, Us

Therapeutic Area: Oncology (Myelofibrosis & Endometrial Cancer)• Contributes to technical infrastructure of CDM• Responsible for timelines and quality of deliverables• Provides feedback and task assignment to meet department and company objectives• Oversight of internal CDM and/or consultant CDM staff • Supports budget and resource planning across assigned projects and/or projects assigned to direct reports• Participates in CRO/vendor selection process for outsourced activities• Participates in the development, review, and implementation of departmental/company SOPs, templates, etc.• Participates in department or cross-functional initiatives• Represents CDM in study team meetings• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines• Generates and/or reviews/approves study documents (e.g., study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external vendor data reconciliation plans, coding conventions)• Oversight of CDM CRO/service providers (e.g., reviewing vendor SOPs, invoices)• Monitors the progress of all data management activities for the project to ensure project timelines are met• Executes and/or distributes data management metrics, listings, and reports, as required

New York, Ny, Us

Therapeutic Area: Oncology (Acute Myeloid Lymphoma & Non-Hodgkin’s Lymphoma)• Assisted in standardizing data management documentation – data validation specifications, case report forms, CRF completion guidelines• Assisted in review of data listings and reports • Performed User Acceptance Testing (UAT) for database go-live and database modifications• Provided CRO and vendor oversight

Basel, Baselstadt, Ch

Therapeutic Area: Neurology/Gene Therapy (Spinal Muscular Atrophy and Rett Syndrome)• Worked with complex computerized records systems and maintain security and integrity.• Provided oversight for collection of data from clinical trials and strategize to support the overall growth/development of the data management offerings for the Clinical Operations department. • Provided oversight for CRF design, edit check specification preparation, and data management plan preparation/execution.• Reviewed and approved design, data review ground rules and database design according to Standard Operating procedures and protocol.• Implemented strategy for data cleaning and the design and programming of clinical databases.• Consulted with other employees to solve operational or data problems.• Provided clerical duties such as data entry, transcription, coding, and collating searches.• Prioritized work in line with project management decisions.• Managed clinical trials through review, computerization, cleaning and auditing of clinical data and databases in compliance with standard operating procedures and regulatory agency guidelines.• Validated clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines.• Generated data retrievals and summaries.• Queried data inconsistencies and revises case report forms in compliance with standard operating procedures.• Reviewed case report forms for completeness and consistency.

Wilmington, Nc, Us

Therapeutic Area: Infectious Diseases, Gastroenterology, and Cardiovascular• Acted 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 oversaw 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.• Mentored junior level staff on all associated tasks within a study. • Liaised with the sponsor and other functional groups as required and communicates with management regarding all data management activities within studies.• Designated 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. • Represented 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• Acted as a Project Manager on a DM standalone study/coordinates multiple projects for a Franchise or Alliance as required.• Led multiple, high volume/highly complex studies

Mansfield, Ma, Us

Therapeutic Area: Oncology (Breast and Leukemia)• Provided Data Management Services for project requirements including Protocol Conversion, Database Build, CRF design, Data Verification, Data Review, Query Management, Coding, SAE Reconciliation• Collaborated with the project team to ensure the deliverables are completed on time with high quality • Performed project management activities for all phases of the project lifecycle, including managing multiple timelines and deliverables for multiple clients and managing client communications as assigned• Provided Quality Control on deliverables developed by team members including JReview Report specifications and deliverables and CDR Custom Modules• Maintained all required Configuration Specifications and Quality Control documents as required by SOP and Processes• Collaborated with training team as an EDC Subject Matter Expert and performs training • Worked on consulting efforts related to systems including UAT, global library/standards development, implementation of Client CDRs• Responsible for oversight of Clinical Data Managers assigned to projects• Ensured compliance with eClinical Solutions/industry quality standards, regulations, guidelines and procedures

Deerfield, Illinois, Us

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

North Chicago, Illinois, Us

Therapeutic Area: Neurology (Alzheimer's), Immunology (Diabetic Pain), 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

Brentford, Middlesex, Gb

Therapeutic Area: Oncology (Hepatic 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

Princeton, New Jersey, Us

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

Blue Bell, Pa, Us

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)

Us

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

Us

• 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