Natasha Loughran
Lisburn,Atrim
Summary
Highly skilled professional with expertise in communication, resourcefulness, and advanced analytical thinking. Proficient in SAS, Power BI, and Microsoft Office Suite including Word, Excel, PowerPoint, and SharePoint. Demonstrates strong problem-solving abilities, critical-thinking skills, and project management experience. Adept at data cleaning, trend identification, database management, and delivering impactful presentations. Committed to leveraging these competencies to drive data-driven decision-making and support organisational goals.
Overview
12
12
years of professional experience
3
3
years of post-secondary education
Work history
Senior Clinical Data Analyst
P1vital
05.2022 - 04.2025
- Work closely with clients to ensure the solution and services provided meet their requirements.
- Act as DM lead on studies which includes developing study timelines, ensuring a plan is in place and constantly reviewing the workload and timelines to ensure these are met.
- Line management responsibilities within the Data Management team, providing mentorship to direct reports.
- Reviewing workload within the DM team and delegating tasks to the appropriate team members.
- Develop study user requirement specifications, requirement traceability matrices and test documentation based on clinical study protocols.
- Work closely with the IT team to ensure they have a good understanding of any changes that are required to support the study requirements.
- Develop clinical study training materials including training guides, system manuals and e-learning presentations, utilising the Learning Management System.
- Deliver training on how to use the data collection system to study sites during the site initiation visits and throughout the study as and when required.
- Develop Data management documentation including but not limited to Case Report Forms, Data management plans, working guidelines, data collection worksheets and Data Management reports, ensuring each are updated throughout the duration of the trial.
- Completing all DM study set up activities.
- Completing all in-study activities including ongoing data cleaning, monthly QC check on data, data query management, reconciliation of source data and data input into the data collection system and data transfers.
- Producing monthly metrics and presenting them to the study sponsor.
- Completing interim data transfers as agreed in the study data transfer specification and completing any ad-hoc data transfers including DSMB data transfers as and when required.
- Completing all study close out activities including pre-final data transfers, final data transfer, database lock and archival.
- Manage data management and statistical analysis services ensuring high quality and completeness of data through collection, processing, querying, and report generation in accordance with data management plans, data transfer specifications and statistical analysis plans.
- Ensure compliance to CDISC standard and GCP compliance throughout.
- Manage study helpdesk support on an ongoing basis ensuring a quality and prompt response to support requests, in line with internal performance metrics.
- Work closely with the Computer Systems Validation Manager and QA Coordinator to ensure all documentation and processes are in accordance with our Quality Management System.
- Develop DM processes and continual review of these processes with the aim of process improvements.
- Assist in the development of standard operating procedures.
- Ensuring compliance with all ICH/GCP/EU/UK regulations governing clinical trials.
- Carried out day-to-day duties accurately and efficiently.
Clinical Data Manager
Northern Ireland Clinical Trials Unit
06.2016 - 05.2022
- Designing databases and managing the data for a number of Clinical Trials.
- Leading clinical trial from the set up process, all in study activities and database lock.
- Completing any quality control checks and data cleaning through the study and at the end of study in preparation for any data transfers.
- SAE/ AE reconciliation and system organ classification experience.
- Generating strong working relationships with research staff from multiple sites across the UK.
- Delivering training and mentoring to research staff from multiple sites across the UK.
- Contribute to the study set up activities including the design and review of study protocols and provide input to the clinical trial team on data management issues.
- Developing Data management documentation including but not limited to Case Report Forms, Data management plans, working guidelines, data collection worksheets and Data Management reports, ensuring each are updated throughout the duration of the trial.
- Contributing to the design of working procedures to aid the data management department as a whole but also trial specific processes.
- Creating and testing data validations that are programmed into the databases to ensure quality and accurate data is captured.
- Ensuring Standard operating procedures are followed.
- Ensuring compliance with all ICH/GCP/EU/UK regulations governing clinical trials.
Clinical Trials Administrator
Northern Ireland Clinical Trials Unit
02.2016 - 06.2016
- Assist in the maintenance of all study documentation within the Trial Master File and the Investigator Site File.
- Attend meeting as and when required and take meetings.
- Ensure minutes are completed to the expected standard and promptly.
- Book travel as and when required.
- Organise meetings and ensure everything is set up prior to meetings.
Clerical Support
Queens University, Student Registry Services
06.2013 - 02.2016
- Working on the student helpline which involved taking considerable number of phone call and emails each day from students that have any general queries about their studies for example completing their registration, counselling services, transcript order requests, timetabling and graduation queries.
- General administration work including University course timetabling, completing student references and filing.
- Typing letters, student reference and reports as required.
- Taking and passing on messages accurately.
- Dealing with port for a number of different departments.
- Creating and updating spreadsheets.
- Updating the university database, QSIS.
- Organising and setting up meetings ensuring all the correct equipment is available, room is correct the size, any catering is sorted, and all applicable paperwork (agenda, minute of previous meeting) has been circulated prior to the meeting.
- Taking minutes at meetings, typing this up accurately post meeting and circulating to all applicable promptly.
- Archiving of paperwork.
- Helping to organise the graduation ceremonies from ticket allocation, handling any study queries, sorting students with the correct gowns and on the day, helping to ensure all runs smoothly.
- Managing and updating boardroom diary each day.
- Managed a group of student helpers in a call centre during the enrolment period.
- Assist on updating all relevant social media platforms.
Education
A-Levels - Applied Science, Leisure and Recreation, Applied ICT
St Patrick's Academy
Northern IrelandGCSEs - English, Mathematics, Religious Studies, Physical Education, Learning for Life of Work, Home Economics, Music, Science
St Patrick's Academy
Northern IrelandBSc - Psychology
Queens University Belfast
Belfast 01.2012 - 05.2015
Skills
- Communication skills
- Resourcefulness
- Knowledge of SAS
- Knowledge of Power BI
- Problem-solving
- Microsoft Word, Excel and PowerPoint
- Microsoft SharePoint
- Advanced analytical thinking
- Data cleaning
- Trend identification
- Project Management
- Database management
- Critical-thinking
- Presentation skills
Personal Information
Date of birth: 11/05/94
Custom
- Association for Clinical Data Management, Attend regular hot topic sessions to further my knowledge in the area.
- OpenClinica, Attended Super User Training in 07/2023.
Timeline
Senior Clinical Data Analyst
P1vital
05.2022 - 04.2025
Clinical Data Manager
Northern Ireland Clinical Trials Unit
06.2016 - 05.2022
Clinical Trials Administrator
Northern Ireland Clinical Trials Unit
02.2016 - 06.2016
Clerical Support
Queens University, Student Registry Services
06.2013 - 02.2016
BSc - Psychology
Queens University Belfast
01.2012 - 05.2015
A-Levels - Applied Science, Leisure and Recreation, Applied ICT
St Patrick's Academy
GCSEs - English, Mathematics, Religious Studies, Physical Education, Learning for Life of Work, Home Economics, Music, Science
St Patrick's Academy
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