Nikki Dallas
Harlow,Essex
Summary
With experience in organising and managing data, I bring strong foundation in analytical thinking and problem-solving. I excel at collaborating with teams, communicating complex information clearly, and ensuring data integrity. My adaptability and proactive approach to learning new systems make me a valuable asset for ensuring seamless data management and optimising processes.
Overview
1
1
Certification
20
20
years of professional experience
Work History
Clinical Data Manager I
NHS Blood and Transplant
Cambridge
05.2023 - Current
- Lead data management activities for trials including delegation and mentoring to junior members of staff.
- Delivered data management expertise, collaborating with senior team members and sponsors to ensure data integrity and compliance.
- Design, Build, test, and maintain electronic data capture (EDC) systems and case report forms, using systems such as MACRO and OpenClinica.
- Monitored incoming clinical trial data, identifying and resolving inconsistencies, errors, and missing data to maintain quality standards.
- Perform database lock activities, ensuring clean data sets and support preparation for final database lock for trial analysis..
- Query management: Generate insight reports using a PostgreSQL platform to track and resolve data queries with clinical research sites.
- Conduct meetings with trial operations team, senior leaders, sponsors, and site staff.
- Maintained document control for trials, ensuring accurate and organised management of data files in compliance with regulatory requirements.
- Oversaw access control procedures to ensure secure database usage by internal and site staff. and requests to the database systems for internal and site staff.
- Manage archival procedures in accordance with internal procedures and regulatory guidance.
- Building and maintaining spreadsheets for data management activities and note taking.
Data Management Support Officer
NHS Blood and Transplant
Cambridge
05.2018 - 05.2023
- Inputted clinical trial data into data capture software: MACRO, OpenClinica, ensuring accuracy and accessibility for analysis.
- Ran reports in data capture software for data monitoring purposes, utilising Metabase and MACRO query module to support data integrity.
- Created and maintained data management files both electronically and in print, facilitating streamlined access and organisation of critical data.
- Building and maintaining spreadsheets for data management activities and note taking.
- Performed updates to the database following the go-live phase to maintain integrity.
- Adhering to internal policies as well as MHRA and GCP practices.
- Receiving, logging, and filing paper Clinical Report Forms (CRFs) received from site.
Scientist
Intertek Melbourn
Royston
07.2006 - 04.2018
- Data analysis testing: Dissolution, Assay, Impurities, Next Generation Impaction (NGI), Emitted Dose (ED).
- Produced comprehensive data analysis reports in alignment with client protocols and internal procedures, ensuring clarity and compliance for stakeholders.
- Utilised data capture systems to collate and analyse data, including LIMs, CITDAS, Atlas, and Atlas report manager, enhancing data accuracy and accessibility.
- Internal trainer and mentor for data analysis testing and data accuracy.
- Client liaison on laboratory and stability projects.
- Led project management activities, coordinating a team of analysts on project timelines, maintenance schedules, report writing, and administrative support for team leader.
- Maintained stability equipment by conducting regular inspections and ensuring functionality.
Education
GCSE
Passmores Comprehensive School
Harlow01-2003
Skills
- EDC system design
- Data management
- Database maintenance
- Data quality assurance
- PostgreSQL querying
- Document governance
- Document management
- Reporting
- Risk assessment
- Task prioritisation
- Client management
- Attention to Detail
Certification
- Scott Bradbury training for trainers certified
- Introduction to Python (Codecademy)
- Code foundations course (Codecademy)
- Full stack engineer - in progress
Accomplishments
- Named author on Clinical trial paper SWiFT: Study of Whole Blood in frontline trauma
Timeline
Clinical Data Manager I
NHS Blood and Transplant
05.2023 - Current
Data Management Support Officer
NHS Blood and Transplant
05.2018 - 05.2023
Scientist
Intertek Melbourn
07.2006 - 04.2018
GCSE
Passmores Comprehensive School