PPD - THERMO FISHER
Senior Clinical Data Team Lead
Nov 2021- Present
Demonstrates full competence when conducting the following tasks:
- Writing metrics and providing outcome reports or monitoring metrics
- Manage a team of reviewers to ensure that they comply with SOPs and internal processes.
- Review SOPs and working instructions to assist in coming stuff on the processes.
- Development of the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers
- Ensuring processes are followed as per protocol-specified parameters, is in the correct format, and data populates to the specified fields sectors.
- The primary contact for internal and external team members regarding processes and data management activities.
- Timelines creation and oversees timeliness of activities and expectations are meet.
- Project management, tasks, and the overall process assigned projects.
- Provide training to the internal and external counter parts to help meet expectations.
- Conduct communicates modes that are proactive to stakeholders on any data management related deliverables.
PRA HEALTH SCIENCE
Lead Data Manager
Nov 2020 – Oct 2021
Demonstrates full competence when conducting the following tasks:
- Assist with development the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers.
- Review to ensures electronic vendor data contains all protocol-specified parameters, is in the correct format, and data populates to the specified fields and patients correctly.
- Serves as the primary contact for internal and external team members regarding data management activities.
- Develops timelines and oversees timeliness of data management activities during the life cycle of studies.
- Tracks milestones, tasks, and the overall budget for assigned projects.
- Communicates proactively to all internal and external stakeholders on any data management related deliverables.
- Forecasts units, hours, and resourcing for data management tasks
- Authors documents such as Data Management Plans, interim lock plans, database closure plans, and database unlocking plans
- Participates in client and/or third-party audits for data management.
IQVIA
Associate Data Team Lead
Jul 2018 – Oct 2020
Demonstrates full competence when conducting the following tasks:
- Work with clinical staff to obtain local laboratory normal ranges for all sites. Research and resolve discrepant information concerning normal ranges and maintain proper documentation.
- Enter (programme into edc) and perform QC for local laboratory normal ranges. Verify that normal ranges are properly attached to patient results in the local lab data collection module.
- Communicate to vendors and client problems involving data transfers, data point issues, and validation issues.
- Review data discrepancies generated by study-specific edit checks for External data and perform the subsequent query management process in resolving the data issues.
- Performs reconciliation between vendor data and EDC data.
- Good understanding of GCP/ICH guidelines and FDA regulations.
- Responsible for data management processes from study start up to lock.
- Resolve all data management study processing activities (data entry, CRF tracking, ect.)
- Assign study tasks to the team and ensure timeline are met.
- Development of study tracking metric report for study team
- Oversee execution of UAT of study specific systems
- Performing/ leading functional QC activities and testing
- CRF Completion Guidelines and reconciliation Guidelines updates
- Ability to work independently and display positive attitude towards client.
- Lead data management projects with oversight management
- Willingness to learn new skill and expand knowledge of drug development.
MMS Holdings Inc.
Associate Data Team Lead
May 2017 – Jun 2018
Demonstrates full competence when conducting the following tasks:
- Good understanding of GCP/ICH guidelines and FDA regulations.
- Responsible for data management processes from study start up to lock.
- Resolve all data management study processing activities (data entry, CRF tracking, ect.)
- Assign study tasks to the team and ensure timeline are met.
- Development of study tracking a metric report for study team
- Oversee execution of UAT of study specific systems
- Performing/ leading functional QC activities and testing
- CRF Completion Guidelines and reconciliation Guidelines updates
- Ability to work independently and display positive attitude towards client.
- Lead data management projects with oversight management
- Willingness to learn new skill and expand knowledge of drug development.
PAREXEL International Limited, GRO,
Clinical Data Analyst II,
August 2015 – April 2017
Demonstrates full competence when conducting the following tasks:
- Development of database build specifications
- SPOC: Study point of contact, keep contact with study team.
- Provide monthly study status and full study matrix.
- Assign study tasks to the team and ensure timeline are met.
- Development of data validation specifications
- Test data creation & UAT
- Performing/ leading functional QC activities and testing
- Create CRF Completion Guidelines, SAE reconciliation Guidelines,
- Data validation and cleaning
- Conduct medical coding.
- Conduct SAE & third-party data reconciliations
- Perform early and final database QC activities.
- Database lock activities
- Maintaining Clinical Study Documents and archiving as appropriate
- Responsible for completeness, timely and quality of clinical data
- Learning role of Primary CDA
- Support site personnel to retrieve missing data as required.
Quintiles Transnational,
Clinical Data Coordinator,
August 2011 – July 2015
- Conduct basic data review.
- Serve as Data Operations Coordinator (with guidance).
- Solve issues through using the global issue escalation/communication plan.
- Write data clarifications as directed by the Data Operations Coordinator.
- Resolve data clarifications, as directed by the Data Operations Coordinator.
- Meet personal project objectives, as assigned by manager.
- Interact with CDM team members to negotiate timelines and responsibilities.
- Escalate problems to the attention of the Data Operations Coordinator or Group Manager.
- Understand and comply with core operating procedures and working instructions.
- Develop and maintain good communications and working relationships with CDM team.
- Perform comprehensive data management tasks including data review, writing and resolving data clarifications.
- Provide data review training within the team and assist with quality review.
- Meet objectives as assigned.
