I am a Data Management professional with 20+ years of global Contract Research Organization experience consistently managing multiple projects and teams, meeting or exceeding deadlines, while training and mentoring within a diverse matrix environment. I have spearheaded training, system integration and validation initiatives, as well as managed strategic partnership alliances. I have a proactive management style based on open communication and setting realistic expectations.
Accomplished managing multiple projects/ sites/vendors across US, Europe, Asia, and India
Oversee direct reports
Seasoned Data Manager with experience in Oncology, Cardiovascular, Alzheimer's, Pain, CNS including imaging endpoints
Developed and implemented training programs for internal and external customers
Proficient using Microsoft Office Word, Excel, Project, Outlook, Lync, SharePoint, Cisco IP Communicator, WebEx
Experienced using the following database platforms -Oracle Clinical, Oracle Clinical RDC, Datafax, eDM, CTMS (ACR developed database), Adaptive Clinical (based on OpenClinica), Medidata RAVE, Clinical Conductor CTMS
Basic knowledge of SQL and SAS.
Senior Project Data Manager, 03/2016 to Current INC Research – Raleigh, NC
Provides line management responsibility as well as acting as Project Leader on partnership Data Management studies (primary customer contact, direct liaison with Finance and Contract departments regarding invoices and change orders).
Acts as Functional Lead for Data Management on full service contracts including: primary contact for internal liaison between Data Management and Company Project Management, Clinical Monitoring, and other functional groups on 'full service' contracts; liaison with Finance and Contracts groups via the Project Leader (e.g., concerning invoicing, contract changes - change orders/change requests).
Ensures launch, delivery and completion of all Data Management deliverables according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.
Clinical Informatics Specialist (Global Data Manager), 04/2015 to 03/2016 PRA Health Sciences – Blue Bell, PA
Managed Data Management timelines and deliverables including Medidata RAVE Database setup, validation, transfers, and all other operational aspects of clinical trials in compliance with Good Clinical Practice (GCP) regulations.
Adhered to financial/administrative processes related to trial budget/timeline management and accurate estimation of resource needs.
Experienced communicating with departments outside of Data Management.
Director, Data Management, 06/2010 to 10/2014 American College of Radiology – Philadelphia, PA
Provided strategic oversight of all Data Management activities and deliverables within an Imaging Contract Research Organization (iCRO) centric research division.
Developed standard operations procedures, work instructions, and designed system requirements for Clinical Data Management System (CDMS) acquisitions.
Supervised managers and acted as system owner of multiple Clinical Data Management Systems.
Manager, Data Management, 02/2008 to 06/2010 Premier Research – Philadelphia, PA
Experienced in project/program management oversight for all data management activities (Data Management Plan, Data Validation Specifications, Data Transfer Specifications. Serious Adverse Event Reconciliation Plan, Protocol Deviation Reconciliation Plan).
Seasoned in presenting at capabilities, bid defense, and investigator meetings.
Managed direct reports (resourcing, mentoring, training, career development, issue resolution, evaluations of staff/financial compensation, invoicing, revenue recognition, adherence to Good Clinical Practices (GCP) standards, standard operation procedures, and working guidelines).
Manager, Data Coordinators, 04/2006 to 01/2008 Premier Research – Philadelphia, PA
Worked closely with Biometrics and Clinical Management to ensure studies were resourced appropriately and deliverables were met.
Interviewed data management personnel, conducted annual reviews, and initiated training programs for new employees.
Provided oversight for database set-up and all data management processes in order to achieve database lock.
Data Coordinator II, 11/2004 to 04/2006 Premier Research – Philadelphia, PA
Conducted interviews and trained Data Coordinators.
Developed a training program for new employees.
Communicated directly with sites.
Clinical Data Manager (part-time), 02/1994 to 11/2004 Premier Research – Philadelphia, PA
Reviewed client data structures and specifications.
Created/implemented edit checks.
Quality Assurance Coordinator, 10/1991 to 11/1993 Research Data Corporation – Haddonfield, NJ
Created Case Report Forms (CRFs) and databases.
Reviewed client data structures and specifications.
Validated Computer Aided New Drug Application (CANDA) systems and trained client/Food and Drug Administration (FDA) on its use.
Clinical Research Assistant, 08/1990 to 10/1991 Research Data Corporation – Haddonfield, NJ
Validated client databases.
Supported Clinical Research Associates in validation of Computer Aided New Drug Application (CANDA) systems.
Conducted review of trial master files (TMFs).
Quality Control Assistant, 08/1986 to 08/1990 Cardio Data Systems – Haddonfield, NJ
Reviewed analysts' 24-hour ECG reports for accuracy.
Coordinated site set-up and client training
in Europe and US.
Developed training curriculum for new personnel in the UK and US.
Senior Analyst, 10/1982 to 08/1986 Cardio Data Systems – Haddonfield, NJ
Assumed supervisor responsibilities when necessary.
Analyzed 24-hour ECG recording.
Reviewed reports for accuracy prior to sending to client.
Bachelor of Arts: Biology, 1981 Rutgers University - Camden, NJ
RCT Certified: 1987 National Board of Cardiovascular Testing - Top 5% in October 1987 exam