Tiffany Eldridge Email & Phone Number

San Diego, California, Us

Suresnes, Fr

Waltham, Massachusetts, Us

Waltham, Massachusetts, Us

• Manage data management projects• DM lead for internal/client team meetings and communication• Produces and Reviews Metric reports for internal/external project team• Ownership for project deliverables within DM scope of services including projections• Discusses roadblocks and solutions for completing project objectives in a timely manner• Reviews project budgets and staffing projections for data management activities• Provides training of other DM staff on project specific processes• Clinical Data and Query Review• Creates the Data Review Plan and the DM listings using ad hoc query tools• Issues queries and review query responses with the highest level of quality based upon the Data Review Plan, Aggregate Checks (DM listings), Reconciliation (LAB, SAE, ECG), other reviewers (Biostatistician, Medical Monitor, Client), and ad hoc reports• Oversees System Development and Modifications:• Drafts the CRF design, edit check specification and DM listings• Facilitates clinical team review of system documents (CRFs, Edit Checks, Data Review Plan, etc.)• Consolidates comments from internal/sponsor for discussion and approval• Ensures all non-DM activities related to database development are completed in a timely manner• Manages all database modifications for DM activities• Validation Creation:• Oversees the entry of data in the Development or QC systems that will be used for validation• Assists with the validation of CRF system (CRF content & edit checks), Reports using EDC Reporting and/or J-Review, and associated change control requests• Provides feedback to the other project team members and managers to improve the deliverables• Creates and Maintains Documentation for the project• Data Management Plan along with supporting DM documents, such as CRF Completion guidelines, Data Entry guidelines, Trial Design Document, Edit specifications, Reconciliation guidelines, and Report specifications• Project Specific SOPs/WPs (as directed by PM)

Watertown, Ma, Us

Supervisor Responsibilities: direct and review the work of a Clinical Data Manager I, Clinical Coordinator, and/or project supporting staff.Assists or develops data management plan for study design and database content development. Configures the data content collection in the EDC system per the research protocol, and may oversee or peer review the configuration for other DMs. Responsible for eCRF testing, edit check development and configuration, documentation, and user training prior to going live. Per project needs, programs specific reports in the EDC system or using SAS, writes reports specification as required by the project’s needs. Assists or develops data transfer agreements for vendor supplied data. Assists in the dissemination of results/findings and maintains communication patterns with physicians, hospital staff and study sponsors. Acts as liaison with all study team members and other functional groups on all levels, on technical requirements for database development and data quality within a study. Oversees data management activities to ensure that the protocol and statistical expectations are understood, timelines are met and communications remain open. Work cooperatively and constructively to develop effective solutions to operational data management problems. Coordinate and supervise project personnel involved in all data management activities/objectives within a study. Evaluates ongoing data management services. Actively contributes to the review of working practices and data management SOP’s. Demonstrates GCDMP knowledge and practices.

Watertown, Ma, Us

Assists and/or develops data management plan components for study design and database content development including study summary/data flow diagrams, timelines, critical variables list, and data review procedures. Configures the data content collection per the research protocol in the EDC system or peer reviews the configuration for other CDMs. Responsible for eCRF testing, edit check development and configuration, documentation, and user training prior to going live. Per project needs, programs specific reports in the EDC system or using SAS, writes reports specification as required by the project’s needs. Assists or develops data transfer agreements components for vendor supplied data. Develops and implements all data management requirements within a study. Develops complex case report forms (CRF’s), complex validations and data collection processes. Interfaces with the study team to ensure that data reporting needs are scheduled and addressed. Coordinates input from project statistician to ensure that Statistical Analysis Plan (SAP) requirements are met. Tracks problems to resolution. Actively contributes to the review of working practices and data management SOPs. Trains site staff on data management systems and processes. Will assist in the development of training and procedures manuals.

Watertown, Ma, Us

* Develop case report forms, including validation specifications for all data elements to comply with protocol requirements * Configure the data content collection per the research protocol in the EDC system * Testing of case report forms (CRF’s), protocol flow and reports. * Investigate data and protocol related issues. * Implement guidelines for Research Assistants and project support personnel to facilitate data cleaning and problem resolution. * Produces edit reports and tracks through to completion. * Checks incoming forms for gross errors and resolves problems with study coordinator.

Boston, Ma, Us

*Utilized PCR techniques to manage and maintain transgenic mice colonies.*Managed all genetic information for strain lineages.*Activated oncogenes via topical treatment examined tissue samples in different stages of nevi development.*Activated oncogenes via genetic mutations, used post-operative techniques to extract tumors.*Aided in amending protocols, and basic administrative duties to ensure all needs by co-investigators were met.

Bachelor Of Science (Bs), Biology

Education record