Bethany Bennett Email & Phone Number

United States

New York, New York, Us

•Defines and drives the data management strategy and standards at the asset level•Partners with stakeholders and external DM service providers to deliver high quality and timely DM deliverables•Serves as a technical resource to the study teams for DM and RBM standards, tools, data provisioning, and reporting•Conducts data risk identification and mitigation at the asset level•Proactively drives quality, efficiency and innovation to meet DM timelines and milestones•Coordinates/executes clinical study data due diligence for third party studies•Accountable for quality study data set release and consistency in asset/submission data •Serves as asset-level DM representative for submissions/audits•Develop ideas, lead/co-lead complex projects across business units and develop plans to achieve objectives.•Serve as Clinical Data Scientist, as needed, for one or more clinical trials assuming responsibility for all activities, including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators and third party study data due diligence.•Act as the key scientific and technical data management expert.•Manage delivery of asset level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the Pfizer portfolio and further precision medicine.•Participate and ensure quality database design including documentation, testing and implementation of clinical data collection tools.•Create quality control processes, metrics and other measures to ensure compliance with standards.•Interface with customers on solutions, requirements, continuous improvement, deployment change management, user groups and workshops, etc.•Coordinate and oversee vendors across various needs.•Manage training and presentation for the team.•Support rapid response, audit and inspection needs and represent domain area.

New York, New York, Us

•Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all DMM activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence•Serve as a technical resource to the study teams for DM and RBM standards, tools, data provisioning, and reporting •Partners with Research/Business Units, external DM service providers and internal DMM staff to deliver high quality data management for all studies as assigned.•Mentor/buddy for junior staff•Participates and ensures quality database design including documentation, testing and implementation of clinical data collection tools, both CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems. •Ensure the required study-specific DMM documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously. •Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity monitoring, data cleaning, e-data processing, data access and visualization, and database release•Strong Project and Risk Management•Acting as an SME for Central Designer•CRO oversight and budget review•Demonstrated successful experience in all relevant clinical data management. •Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review.•Strong verbal and written communication skills. •Consistent, detail oriented, communicative, dedicated.

Durham, North Carolina, Us

PROFESSIONAL EXPERIENCE:Senior Data Operations Leader, PAREXEL International, Durham NCMay 2013 - April 2018Coordinate DM activities on international multi center trials. Implement strategies to ensure timely set-up, ongoing and close out tasks for clinical studies.Have oversight of the CDA, DB programming and Biostatistician activities to ensure established milestones are met. Manage clinical trials including study budget management and vendor support.Provide EDC training at investigator meetings.Responsibilities for managing study resources and timelines.Provide a point of contact for project questions and concerns.Manage and mitigate study risk factors.Responsible for maintaining client relationship and meeting expectations.Create project plans, and documents and maintain project deliverables.Coordinate and tracks tasks across assigned CDS functions.Review project information, gather input / create MSP timelines, implement and trackmilestones and timelines, monitor progress and provide updates as required. Recognize and manage areas of risk, discuss risks with appropriate CDS members andformulate contingency plans. Request, evaluate and identify resourcing needs and provide performance feedback asappropriate to the CDS Line Managers and Head of DOLs. Organize and participate in sponsor, investigator and team meetings. Identify and facilitate study training needs in collaboration with CDS Line Managers. Identify possible quality concerns and escalate these to the appropriate functional Project Leadsand Line Managers. Assist with the preparation and attend possible RRC or Sponsor audits/inspectionsCompile monthly status reports in a timely manner Provide input to Revenue Recognition process Effectively communicate with internal and external customers as well as third party vendors. Establish good working relationships with other project and functional leads / CDS

Durham, North Carolina, Us

Data Operations Leader, PAREXEL International, Durham NCJuly 2011 – April 2013Coordinate DM activities on international multi center trials. Complement strategies to ensure timely set-up, ongoing and close out tasks for clinical studies.Have oversight of the CDA, DB programming and Biostatistician activities to ensure established milestones are met. Manage clinical trials including study budget management and vendor support.Provide EDC training at investigator meetings.Responsibilities for managing study resources and timelines.Provide a point of contact for project questions and concerns.Manage and mitigate study risk factors.

Bedminster, Nj, Us

Summary:Responsibilities include Project Management and performing all the DM activities from study initiation through close out:Responsible for account management for EDC studies.Design and develop eCRF's and EDC specifications for database set-up.Creation to data management documentation such as DMP's, data validation guidelines, QA plans, etc. Global oversight of DM activities in India.Management of project activities of a large number of studies including timeline management, metrics, budgets, forecasting, staff, project scope, reports and communication.Communication with statistician to achieve data quality and expectations.Responsible for vendor oversight and coordination of vendor data transfers and reconciliation.Participation internal team meetings, training, and project related meetingsDevelopment of SOPs/GDs, project related documentation as well as revising these documents Delivery EDC training to CRA's site staff and internal team members.Management of multiple projects/protocols to meet strict deadlines while following Sop's.Creation of data listings for review of data to insure quality.Responsible for the integrity of data structure and database set up. Strong analytical skills and the ability to problem solve.Delegation of study related tasks.Ability to organize, prioritize and adjust to a constantly changing environment.Experience in many therapeutic areas/indications and an awareness of new industry technologies and changing methods.Training of new data management staff, and providing ongoing support where needed.Maintaining good client relationships.

Summary:Responsibilities include leading and performing all the DM activities from study initiation through close out:Assisting/facilitating the EDC growth within data managementSolely co-ordinates and/or conducts all study set-up, maintenance and closeout activities in "RDC onsite"Responsible of the setup of the EDC strategyManagement of project activities of a large number of studies including timeline management, budgets, staff, project scope, reports and communication.Conducting internal team meetings, training, and project related meetingsDevelopment of SOPs/GDs, project related documentation as well as revising these documents Delivery of study specific and RDC hands on training at investigator/monitor meetingsManagement of multiple projects/protocols to meet strict deadlines while following SOP'sResponsible for the integrity of data structure and database set up Strong analytical skills and the ability to problem solveDelegation of study related tasks Ability to organize, prioritize and adjust to a constantly changing environmentExperience in many therapeutic areas and an awareness of new industry technologies and changing methodsTraining of new data management staff, and providing ongoing support where needed.

Brentford, Middlesex, Gb

.Lead DM cleaning activities for US and Global studies.Lead responsibility for all studies in a specific compound·Management of external data and vendors, including contracts and specifications.4.5 years experience with the EDC platform InForm version 4.1/4.5.Reports development using Cognos, InForm reporting interface·Delivery of study specific and InForm hands on training at investigator/monitor meetings·Responsible for the integrity of data structure and database set up ·Strong analytical skills and the ability to problem solve.Delegation of study related tasks ·Ability to organize, prioritize and adjust to a constantly changing environment·Experience in many therapeutic areas and an awareness of new industry technologies and changing methods·Training of new data management staff, and providing ongoing support where needed·Participation in team project meetings·Development of Annotated CRF’s to prepare for database set up·Reconciliation of error output from validation listings ·Generation of queries to be resolved by clinical monitors and study sites ·Database edits/changes using a variety of computer systems·Reconciliation of Adverse Events, PK, PGx, ECG’s and SAE’s, ·Conducted QA reviews on data and maintained tracking systems·Handling of external laboratory data·Medical coding of all pertinent concomitant medications and adverse events·Preparation of all study file documentation for·Worked as a member on cross-functional project teams·Facilitation of study related meetings ·Provide 1 on 1 system training at Investigator Meetings·Participated in development in therapeutic standards for GI and Oncology ·Preparation of presentations for study related functions·Generate database specifications for internal and external data·Maintain study metrics and tracking·Conducted UAT on several new standard tools

Summary:Responsibilities include designing, maintaining and validating clinical trial databases. Development includes providing an optimal database design for data entry, data management and reporting groups, without compromising data integrity. Create validation programs using SAS, SQL and GOLD Design Data Entry applications using LESA and Entry Point 90 Creation of relational database tables and SASVIEWS used for data analysis Manage multiple projects/protocols to meet strict deadlines while following SOP's Responsible for the integrity of data structure and database set up Strong analytical skills and the ability to problem solve Ability to organize, prioritize and adjust to a constantly changing environment Experience in many therapeutic areas and an awareness of new industry technologies and changing methods Train new programming and data management staff, and provide ongoing support where needed Participate in team project meetings and work with group members to achieve necessary results Development of Coding Manuals to prepare for database set up

Summary:Responsibilities include ensuring the quality, consistency and integrity of clinical trial data, while maintaining multiple projects/protocols. Development of validation manuals for programming Reconciliation of error output from validation listings Generated queries to be resolved by clinical monitors and study sites Made database changes using a variety of computer systems Reconciliation of Adverse Events and SAE's, including interaction with Drug Surveillance Organize, prioritize and adjust to constantly changing project demands Trained new staff and provided ongoing support where needed Worked as a member on cross-functional project teams Assisted in the development of Coding Manuals to prepare for database set up Medical coding of all pertinent concomitant medications and adverse events Preparation of all study file documentation for Regulatory Compliance audit Oversight of other team members' work Managed projects in many therapeutic areas Conducted QA reviews on data and maintained tracking systems Handled external laboratory data per working practices

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Bachelor Of Science, Biology, Chemistry