John V. Mitchell Email & Phone Number

New York, New York, Us

· Responsibile for all DM&M activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence· 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. · Serve as a technical resource to the study teams for DM and RBM standards, tools, data provisioning, and reporting· Partners with Research/Business Units and any external DM service provider to deliver high quality data management for all studies as assigned.· Proactively drives quality and efficiency to meet timeline and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team (s).· Ensure work carried out by DM providers is in accordance with applicable SOPs and working practices.· Ensure the required study-specific DM&M 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.

•Participate as the primary data management representative on Incyte multidisciplinary project teams and ensure effective communication exchange•Perform ongoing data review, including reconciliation of third-party data streams and serious adverse event reconciliation with the safety database.•Perform User Acceptance Testing (UAT) of clinical databases.•Perform Quality Control (QC) of clinical databases.•Generation and maintenance of data management-related documentation•If applicable, overseeing that the Contract Research Organizations (CROs) utilized by Incyte Corporation (IC) perform data management activities in accordance with ICH/Good Clinical Practices (GCP).•Other duties, as assigned

Interface with CRO’s and Lab Vendors on multiple studies.Works directly with CRA, and other Clinical, Drug Safety, and Project Management staff to meet project deliverable and timelines.Reviews study protocols and assists site coordinators, investigators, and field clinical staff in collecting data to meet the protocol requirements in a timely manner.Perform User Acceptance Testing (UAT) of clinical databases.Perform Quality Control (QC) of clinical databases.Perform ongoing data review, including reconciliation of third party data streams and serious adverse event reconciliation with the safety database.Perform ongoing updates of Data Management related documentation, as needed.

Interface with CRO’s and Lab Vendors on multiple studies.Works directly with CRA, and other Clinical, Drug Safety, and Project Management staffs to meet project deliverable and timelines.Reviews study protocols and assists site coordinators, investigators, and field clinical staff in collecting data to meet the protocol requirements in a timely manner.Perform User Acceptance Testing (UAT) of clinical databases..Perform Quality Control (QC) of clinical databases.Perform ongoing data review, including reconciliation of third party data streams and serious adverse event reconciliation with the safety database.Perform ongoing updates of Data Management-related documentation, as needed.

Princeton, New Jersey, Us

• Conducts manual data review and coding for data management customers• Assists in Study specific training • Issues queries based on manual data review specifications in the data management plan for each assigned study• Participates in project team meetings as necessary• Maintains metrics and reports for their individual performance of study database • Assists in the management of the database cleaning and locking process• Performs data management user acceptance testing as needed/directed by the data manager

Raleigh, North Carolina, Us

• Assists in Study Maintenance from startup to database lock• Review designs, for CRF pages and e-CRF entry screens and associated CRF/eCRF visit structure• Perform User Testing for data entry screens • Perform User Testing and Analysis of Electronic Edit Checks. • Perform Lab Reconciliations as well as Conmed and AE Listing reviews• Perform review of discrepancy (edit check) output and validation listings based on data entered into the CRF database• Perform QC listing review, audit activities including 100% QC of CRF’s.• Ensure all Case Report Forms (CRFs) and Data Clarification Forms (DCFs) received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects• Participate in implementation of new technologies. Contribute to Data Management process improvements • Distribute status reports to both client and internal team members• Participate in client teleconferences and project team meetings • Train and mentor less experienced data management staff

Maintained audiovisual componentsDiagnosed technical issues of A\V EquipmentEquipped audio/video component for conferencesReported all activity and equipment usage on a monthly basis

Tracked all incoming and outgoing shipmentsEnsured the delivery of all incoming shipments to 200 employees on a daily basis Reported all activities on a monthly basis

Philadelphia, Pennsylvania, Us

Philadelphia, Pennsylvania, Us