SHARON HARDY

North Brunswick, NJ

908-***-****

SUMMARY:

BA Degree

Cardiovascular, Neurology, Oncology, OTC and Medical Device experience

13+ years of Lead Data Management experience

13+ years of experience managing timelines, deliverables and metrics

13+ years of global experience

13+ years of experience performing listing reviews

5+ years of budget experience

2+ years of CRO management/oversight experience

3+ years of Inform experience and 1 years of RAVE experience

PROFESSIONAL EXPERIENCE:

Mitsubishi Tanabe Development America, Inc., Jersey City, NJ

February 2018 to Present

Sr. Manager, Data Science (Consultant)

Responsible for managing all data collection, processing and delivery aspects in the assigned clinical studies

Develop and implement study-level data management planning to ensure that the outsourced and in-house activities are completed according to the agreed scope, quality standards and timelines

Responsible for day-to-day coordination of ongoing data management activities acting as data management functional representative in the study teams

Work with internal and external cross-functional teams, will coordinate design, validation, implementation, and maintenance of data acquisition instruments and modalities, validation and finalization of study databases, and preparation of data management deliverables for ongoing data monitoring and for use in the interim and final analyses

Serve as the subject matter expert on topics related to data management activities

Contributions include, but are not limited to: vendor selection and management, representing data management function in the clinical operation team for the assigned studies, collaboration with MTDA and global data science staff (data management, statistics, clinical pharmacology, programming), collaboration with MTDA Clinical Development staff, cross-functional collaboration with other departments at MTDA and the global organization

Support outsourcing activities by providing input on data-related budget, scope and requirements (e.g. RFP, scope of work, vendor costing, change orders, etc.), vendor selection and management, risk and communication management, and application of best data management practices and regulatory requirements

Coordinate development of study-specific data acquisition solutions (paper and/or electronic) that adhere to the study protocol, the development program, industry regulations/standards, and Company standard procedures; this includes overseeing the specification/design, validation, and implementation, maintenance, decommissioning and archiving steps, relevant planning, quality control and documentation

Manage clinical data processes to ensure integrity and adequate quality of data, including the outsourced or in-house validation and reconciliation of all study data modalities, review of data transfers, data transformation and mapping (specifications and actual data structures), planning and implementation of data quality review

Accountable for data management activities to support the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of programmed protocol deviations, manual data listings, and coordination of in-house interim and final Data Review Meetings, preparation and completion of the associated documentation

Responsible for coordinating routine study-level data management activities in accordance with the study project plan, including but not limited: eCRF and eCOA/ePRO design; system integration, validation and UAT; edit checks; study-specific data management procedures; data management plans and reports: coding of medical terms, SAE and external data reconciliation; query resolution; mapping specifications; completion of data management portion of the trial master file

Participate in the development, review and updating of data management SOPs and working practices

Participate in process improvement initiatives

Perform other departmental duties as assigned

Statistics & Data Corporation, Home-Based, NJ

August 2016 to February 2018

Senior Clinical Data Manager

Spearheaded study setup including CRF design, database structure development, annotation, document creation and/or approval, data entry screen and edit check testing and approval, etc.

Proactively planned, allocated and prioritized workloads for multiple projects (to include media control, data entry, pre-entry review and discrepancy management and assessment tasks, as applicable)

Worked independently to oversee day to day data management project activities

Established, monitored and maintained timeline for data management responsibilities

Mentored Clinical Data Managers and Clinical Data Analysts

Assisted other CDMs and CDAs with the management of tasks, timelines and budgets as they pertained to data management activities on projects

Communicated with cross functional groups throughout the project lifecycle

Planned and conducted internal and external team meetings

Participated in presentations to clients, sites, and cross functional groups

Monitored project budget and project scope, as they related to data management activities, and communicated project status regularly to senior management

Provided project team with regular updates on project progress pertaining to data management activities

Assumed full project management responsibility for all data management activities

Trained Site Coordinators, Clinical Research Associates, and Investigators on clinical data entry, discrepancy management, CRF page verification, and CRF page approval processes

Developed, maintained, and analyze assigned project metrics such as completed pages, discrepancy aging, etc.

Established causes and implemented corrective actions for adverse trends that were identified

Maintained quality control of the clinical data, project deliverables and closeouts

Oversaw the review of medical coding for validity and completeness

Adhered to all aspects of SDCs quality system

Complied with SDCs data integrity and business ethics requirements

Performed other duties as assigned

Eisai Inc., Woodcliff Lake, NJ

June 2014 to August 2016

Clinical Data Manager (Consultant)

Performed all DM activities for Oncology studies

CDM Lead DM for Oncology Thyroid Study

Project management for global Oncology projects

DM support for multiple Oncology studies from study start up to DBL

Reviewed and cleaned data in Inform 4.4 & 5.0

Independently performed all data management functions to ensure timely and quality database lock for studies Phase I-III

Performed data management activities for EDC studies conducted in-house (protocol review, CRF development, CRF review, database set-up activities, data validation process; medical coding, SAE reconciliation, etc.)

Customized and ran reports through J-Review

Supported studies as needed during critical timelines

Developed and maintained good communications and working relationships with CDM team

Understood and complied with core operating procedures and working instructions

Managed delivery of projects through full data management process life-cycle

Worked with third part vendor to ensure specifications for transfers were acceptable

Liaised with vendors to ensure discrepancies were resolved during the reconciliation process

Third Party Reconciliations including Echo, Central Lab, PK etc.

Responsible for local labs and the process involved with obtaining and entering within Oracle Clinical as well as liaising with clinical to correct any pending issues

Monthly listing reviews

Reviewed and updated Working Instructions and SOPs

Performed SAE Reconciliation

Performed Tumor Assessment review

Customized specifications for study specific listings and worked with programming to generate

Special projects as requested by Director

Quintiles, Home-Based, NJ

September 2013 to June 2014

Data Team Lead

Served as Data Team Lead (DTL) on multiple global studies, providing leadership to the DM team

Served as back-up for Data Operations Coordinator or Data Team Lead, providing leadership and technical expertise to Operations team

Managed project timelines and quality issues, determined resource needs, and identified and justified out-of-scope

Provided input for negotiations with customer

Solved issues through using the global issue escalation/communication plan

Consulted with Standards Group for process issues and communicated ideas for process improvement

Managed DM customer relationship for DM project team including active participation in DM customer negotiation on timeline, budgetary and other issues

Developed and maintained good communications and working relationships with CDM team

Understood and complied with core operating procedures and working instructions

Managed delivery of projects through full data management process life-cycle

Allergan, Inc., Bridgewater, NJ

September 2012 to September 2013

Senior Clinical Data Manager (Consultant)

Provided specialized knowledge and detailed attention to carry out data management data review activities in support of one or more clinical studies

Worked within clinical study teams as an extended team member

Executed the clinical data management operations against project timelines, and any other priorities

Used defined department metrics as a framework for timely and quality clinical data management deliverables

Acted as a Lead Data Manager Medical Device study

Responsible for the role which included executing the design, documentation, testing, and implementation of data collection systems and processes in support of the clinical study teams

Trained study site personnel in CRF completion and data clarification processes

Coordination of all Data Management Data Review activities and any other Clinical Study Team Data Review, ensuring completion of all activities leading to the Study Database Lock

Responsible for the role which included the execution of the data review strategy for one or more studies as defined by the individual study Data Management Plan

Initiated and managed data clarification process, coordinating with other stakeholders to ensure appropriate resolution to all data clarifications prior to database lock

Vital part of the hiring process for new candidates

Managed DM team members that were assigned to studies lead by me

Traveled to Medford, Mass bi monthly for Clinical/DM face to face, leading the DM meeting and work session

Supported other LDMs during crucial timelines to assist meeting deadlines

Merck, Kenilworth, NJ

December 2010 to September 2012

Clinical Specimen Management Data Steward (Consultant)

UAT Lead for major Clinical Specimen Management System (CSMS) and BBMS releases

Lead UAT team and organized all UAT tasks from start to finish

Wrote test cases for UAT releases

Entered all new test cases into Quality Center (QC)

Led Kick off meeting for major UAT releases

First Point of Contact for UAT testers that needed assistance executing test cases

Entered mock data in CSMS to prepare for UAT

Entered test data into InForm to prepare for flow into BBMS testing environment

Responsible for the update of new dictionary terms and analysis within CSMS/BBMS

Lead Role in Retrospective Clean Up Project – reconciling trackers vs CSMS and working with Country Operations to get consent deviations entered

Prepared slide presentations for bi-weekly production meetings which detailed the IT details of helpdesk tickets submitted by users of CSMS/BBMS

Team member for Quest integration project

Granted protocol access within CSMS for qualified individuals

Turned off access for users no longer needing access

Updated SOPs relating to CSMS/BBMS

Liaised between CSMS/BBMS IT, business and CSMS/BBMS users

Triaged CSM mailbox

Updated waiver exemptions tracker on a weekly basis

Ran reports in Spectrum/CTMS

CMED, Murray Hill, NJ

May 2008 to October 2010

Senior Clinical Data Manager

Trial Data Manager for multiple oncology trials

Ensure tasks documented in the study contract were completed on time and be able to assist monitoring the project budget and resources

Responded to requests made by the Sponsor for information or presentations such as workshops and project planning meetings as appropriate

Communicated effectively with the Sponsor via e-mail, telephone conferences, presentations etc., in order to fully manage and lead the project or trial

Participated in and supported Business Development activities, i.e. bid defense meetings etc.

Actively promoted and represented Cmed via attendance at meetings and conferences and as appropriate, became a member/involved with professional associations

Improved effectiveness of the organization such as developing new processes, systems and Sponsor relations

Assisted and acted as deputy for Data Management Operations Team Manager as appropriate

Ensured relevant Sponsor and/or CMED CRS Working Practices or Standard Operating Procedures were adhered to

Prepared Data Management Plan (DMP)

Wrote CRF Completion Guidelines (CCGs)

Wrote Data Transfer Specs (DTS)

Ensured all documents were filed in TMF

Train Data Managers assigned to trial

Reviewed and provided feedback on Protocol to Clinical

Reviewed and provided feedback to Database Programmer on CRF

UAT of database screens

Prepared UAT documents

Wrote validation checks

Performed SAE reconciliation

Ensured timely and accurate entry of relevant study information and time recording occurred in the Management Information System (MIS)

Presented at Clinical Trial meetings to give updates of trial status from DM standpoint

Presented at Investigator meetings globally

Prepared DTS for central lab, ECG and Biomarker data

Reviewed and provided feedback on monitor listings and patient profiles as they were prepared by the Programmers

GlaxoSmithKline, Philadelphia, PA

February 2007 to October 2007

Clinical Data Scientist (Consultant)

Performed study start up activities for outsourced studies

Prepared all documentation for CRO including data management plan

Managed outside CRO to ensure study timelines and data management activities were being met

Prepared and provided CRO necessary documents to perform necessary data management activities for given trial

Performed QC of CRO activities to include UAT, Data Review, query management etc.

Reviewed and provided feedback of CROs development of DMP, edit checks, DBL processes etc.

Responsible for entering laboratory values and results as needed

Performed data cleaning activities in Inform for in-house studies

Provided updates to senior management during weekly meetings

Forest Laboratories, Jersey City, NJ

May 2006 to February 2007

Clinical Data Manager (Consultant)

Generated, processed, tracked, and resolved queries

Performed UAT on database and data transfers

Performed SAE reconciliation between the clinical database and the drug safety database

Reconciled lab data transfers

Closed study database based on pre-defined criteria

Performed all data cleaning activities in Inform and Clintrial 4.3

GlaxoSmithKline, Parsippany, NJ

June 2005 to February 2006

Clinical Data Manager (Consultant)

Performed SAE reconciliation between clinical and safety databases ensuring that the data was consistent and acceptable

Lead DM for Smoking Cessation trial and assistant DM for numerous other studies

Responsible for data management activities such as CRF design, tracking CRFs, reviewing CRFs, medical coding, UAT testing, edit checks etc.

Represented data management team at meetings to establish project timelines and ensure milestones were met

Created data entry guidelines for data entry team

Performed coding of adverse events and conmeds using MedDRA

Applied corrections/updates that were identified through query resolution to appropriate documents/database

Documented and addressed any errors, omissions and inconsistencies found during clinical data review

Novartis Pharmaceuticals, Florham Park, NJ

November 2004 to June 2005

Clinical Data Manager (Consultant)

Responsible for data review and cleaning and all activities leading up to and including database lock for assigned international Cardiovascular studies in an EDC environment

Froze clean data and queried missing or inconsistent data

Performed crosschecks to ensure data was clean

EDUCATION:

Hampton University, Hampton, VA

B.A Psychology

TRAINING:

Studying for CDM Certification: Current

RAVE: September 2013

Providing Constructive Feedback: Train the Trainer: January 2010

ICH Guidelines: February 2007

Inform Training and Certificate: February 2007

Manager CROs: February 2007

Clintrial 4.3, 4.4: May 2006

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