Carmen McDonald
Winnipeg,MB
Summary
Versatile Clinical Data Management Specialist with results-driven and focused approach to completing work. Skilled leader, planner and problem-solver with 25 +year career in Pharmaceutical and Clinical industry. Known for excellent attention to detail and great work ethic. Seasoned Specialist offering 19 years of comprehensive experience interpreting and implementing quality standards and investigating customer care and non-conformance issues. Practiced and knowledgeable professional possessing excellent problem solving and analytical skills paired with strong knowledge of Data Management terms, tools and methodologies. Committed to improving overall business processes. Dependable Clinical Data Management Specialist with track record of success in field, attention to detail and proactive mindset. Seeks opportunities to improve processes and workflows for team benefit. Conscientious, hardworking and excels at multitasking in fast-paced environments. Hardworking employee with customer service and time management abilities. Devoted to giving every patient a positive and memorable experience. Hardworking with strong ability in Medical Coding pertaining to Medical History, Concomitant Medications and Adverse Events. Highly organized, proactive and punctual. Ambitious, career-focused job seeker, anxious to obtain an exciting position to help launch my career while achieving company goals. Hardworking and reliable with strong ability in Data Management. Highly organized, proactive and punctual with team-oriented mentality. Hardworking and reliable with strong ability getting the job done. Ambitious career-focused job seeker, anxious to obtain an entry-level, mid-level position to help launch career while achieving company goals. Intends to develop professional work experience utilizing excellent communication and time management skills. Years of experience in Certified Medical Coding with excellent research, technical, and problem-solving skills. Detail-oriented and able to learn new concepts quickly.
Overview
33
33
years of professional experience
Work History
Clinical Data Management Specialist
Emergent BioSolutions
01.2018 - 08.2023
- Prioritize work in line with project management decisions
- Perform UAT testing prior to database go live
- Manage clinical trials through review, cleaning and auditing of clinical data and databases in compliance with standard operating procedures, client guidelines and regulatory agency guidelines
- Query data inconsistencies and revise case report forms in compliance with Data Management Plans and Standard Operating Procedures
- Generate Data Management Plans and forms applicable to those plans specifically
- Manage filing of documentation in the clinical trial master files
- Apply appropriate medical coding using the MedDRA browser for medical history, concomitant medications and adverse events as a Certified MedDRA Coder
- Work with Pharmacovigilance to perform SAE reconciliation for all studies
- Collaborates with other functional areas and works with cross-functional teams to promote understanding and achieve strategic objectives
- Communicate required departmental work activities to ensure that corporate, project and unit objectives are completed efficiently within defined timelines.
Technician, Clinical Data Management
01.2014 - 01.2018
- Follow in-house data tracking procedures
- Help maintain clinical trials in-house
- Enter data for clinical trials
- Familiar with SOPS that apply to specific clinical data trials
- Archive clinical data and documentation as required
- Print and assemble CRFs/other data forms
- Maintain and file reports/correspondence for clinical data which include; writing of queries and resolving discrepancies
- Design of CRFs
- Trained clients on log-in to applicable clinical trial systems
- Verify data in the ClinTrial database system.
Data Management associate
Cangene Corporation
01.2003 - 01.2014
- Follow in-house data tracking procedures
- Help maintain clinical trials in-house
- Follow in-house data tracking procedures
- Help maintain clinical trials in-house
- Enter data for clinical trials
- Familiar with SOPS that apply to specific clinical data trials
- Archive clinical data and documentation as required
- Print and assemble CRFs/other data forms
- Maintain and file reports/correspondence for clinical data which include; writing of queries and resolving discrepancies
- Design of CRFs
- Verify data in the ClinTrial database system.
Laboratory Technician
Cangene Corporation
01.2002 - 01.2003
- Generated, performed and followed up on Product Development Study Protocols
- Organized equipment and supplies in a timely matter for study protocols and pilot plant purifications
- Assisted lab personal by providing all resources that were needed for pilot runs and which included filters, tubing, chemicals and all that was required on batch records for proper development runs
- Performed purification procedures such as chromatography, ultrafiltration, formulation and sterile filtration
- Performed analytical techniques such as: biuret protein, IgG, RID/LL, IgG RIG MADD, Agarose Gel, Electrophoresis and Apolipoprotein-B.
- Collected, labeled and stored lab samples according to laboratory specifications.
- Analyzed data using various software programs including Microsoft Excel.
- Developed processes and techniques to improve the efficiency of laboratory operations.
Laboratory Assistant
01.1997 - 01.2002
- Implemented and oversaw the calibration and verification of all pipettes in each department in both of the Cangene locations in Winnipeg
- Trained lab personnel on pipette calibration and verification systems for pipettes in all departments
- Implemented and maintained Product Development study databases (chemical inventory, Product Development study protocols, lab books, etc
- Regulated PD plasma inventory and cooler systems
- Preparation and revision of SOP/STMs when required
- Ordered supplies and maintained records for purchase orders
- Prepared and dispensed routine laboratory solutions following standard operating procedures
- Operated/calibrated pH meters, conductivity meters and other routine laboratory equipment
- Dispensed raw materials for experimental laboratory runs and contract runs
- Made photocopies, sent faxes and sorted/filed protocols and other material when required
- Prepared laboratory glassware and utensils and maintained the laboratory in a clean and orderly fashion.
Food processing/package technician
01.1992 - 01.1996
- Processed and packaged turkey for distribution
- Cleaned and maintained all equipment that was in production
- Trained new employes on various procedures.
Hostess Cashier
01.1991 - 01.1992
- Relieved primary cashier when required
- Assisted waitresses when necessary
- Organized and maintained front lobby and other areas the seating area and kitchen
- Trained new employees on hostess/cashier and waitress responsibilities.
Human Resources Assistant
01.1997
- Relieved primary secretary when required
- Assembled and distributed orientation books for employees
- Assisted in generating new employee name tags/cards on the photo ID instrument
- Made photocopies, sent faxes and sorted/filed resumes when required
- Delivered mail and interoffice documents to all departments
- Scheduled interviews for Human Resource Manager to assure that all appointments and interviews ran smoothly.
Education
Administrative Assistant
Academy of Learning
Winnipeg06-1997
Some College (No Degree) - High School
Sturgeon Creek
Winnipeg, MBTimeline
Clinical Data Management Specialist
Emergent BioSolutions
01.2018 - 08.2023
Technician, Clinical Data Management
01.2014 - 01.2018
Data Management associate
Cangene Corporation
01.2003 - 01.2014
Laboratory Technician
Cangene Corporation
01.2002 - 01.2003
Laboratory Assistant
01.1997 - 01.2002
Human Resources Assistant
01.1997
Food processing/package technician
01.1992 - 01.1996
Hostess Cashier
01.1991 - 01.1992
Administrative Assistant
Academy of Learning
Some College (No Degree) - High School
Sturgeon Creek