Archie McDonald
bideford,...
Summary
A highly skilled professional with expertise in document control and management, specialising in Trial Master File for clinical trials and Device Master File for medical devices. Demonstrates exceptional communication skills and remains calm under pressure, excelling in problem-solving and database design. Committed to leveraging these competencies to enhance operational efficiency and support organisational goals.
Overview
53
53
years of professional experience
Work history
Not Working
2023.04 - 2026.04
- Time with family in Australia
TMF Specialist
IQVIA
2019.02 - 2023.03
- Managed multiple trial master files for Novartis studies as TMF Specialist at IQVIA.
- Coordinated document specialists in India and China for TMF activities.
- Migrated legacy and paper study documents into Veeva Vault with QA checks.
- Present at FDA and MHRA audits.
Full time carer taking care of wife
Bideford
2018.04 - 2019.01
TMF Owner
Execupharm
2016.04 - 2018.04
- On contract to ExecuPharm.
- Trial Master File owner on behalf of Pfizer.
- Start up, monitoring and close out of Trial Master Files across various systems.
- Use of inventories and placeholders to monitor same.
- Issue resolution and change control.
- Boosted customer satisfaction with consistent quality control measures.
- Oversight of Trial Master Files to ensure regulatory compliance and inspection readiness at all times.
- Boosted customer satisfaction with consistent quality control measures.
- Present at FDA and MH RAaudits.
Senior TMF Specialist/Document Control Manager
Daichi Sankyo
Gerrards Cross, Berkshire
2008.01 - 2016.04
- On contract to Daiichi Sankyo.
- Oversight of UK and European TMFs within Daiichi Sankyo.
- Responsible for Records Management Document Control for UK / European operations for Daichi Sankyo.
- Part of team implementing EDRMS systems into Daiichi Sankyo.
- Implementing various SOPs and SOIs into company.
- Recruitment and management Document Specialists.
- Improved workflow efficiency with thorough process analysis.
- Performed regular system backups, preventing potential data loss.
- Resolved technical issues promptly, enhancing overall system performance.
- Planned staff and resources within business budgets for minimised expenditure.
- Present at FDA and MHRA audits.
Document Control Manager
KCI Medical Devices
Ferndown, Dorset
2000.01 - 2008.04
- Responsible for Document Control in UK for Texas based Medical Device company.
- Creation of database using Access and roll out to UK.
- Carried out day-to-day duties accurately and efficiently.
- Quickly learned and applied new skills to daily tasks, improving efficiency and productivity.
- Successfully delivered on tasks within tight deadlines.
- Oversight of Device Master Files and Device History Files to ensure regulatory compliance and inspection readiness.
- Present at FDA and MHRA audits.
Document Control Manager, Technical clerk roles with various companies
Various
Various, Various
1973.01 - 2008.01
- Oil and Gas North Sea Oil development projects including ten years at Shell UK.
- Other companies worked for included BP and Marathon Oil.
- Oversight of workflows for engineering drawings and specifications.
- Worked in North Sea platforms, UK, Thailand and Nigeria.
- Working in a regulatory environment.
- Implemented process improvements for enhanced operational effectiveness.
Education
A-Levels - Mathamatics and English Language
Brockenhurst College
England /1970 - /1972
GCSEs - Mathamatics, English Language, English Literature,History, Chemistry and Physics.
Abbey School
Trinidad /1965 - /1970
Skills
- Communication skills
- Calm under pressure
- Problem-solving
- Document Control and Document Management
- Database design and construction
- Trial Master File expert clinical trials
- Device Master File and Device History File expert Medical Devices
- Calm under pressure
Timeline
Not Working
2023.04 - 2026.04
TMF Specialist
IQVIA
2019.02 - 2023.03
Full time carer taking care of wife
2018.04 - 2019.01
TMF Owner
Execupharm
2016.04 - 2018.04
Senior TMF Specialist/Document Control Manager
Daichi Sankyo
2008.01 - 2016.04
Document Control Manager
KCI Medical Devices
2000.01 - 2008.04
Document Control Manager, Technical clerk roles with various companies
Various
1973.01 - 2008.01
A-Levels - Mathamatics and English Language
Brockenhurst College
/1970 - /1972
GCSEs - Mathamatics, English Language, English Literature,History, Chemistry and Physics.
Abbey School
/1965 - /1970