Leadership & Management

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Mohsen Ghahremanlou

PhD (DCLS), MSc, CRPRA

Phone: 416-***-****

Email: ad77rm@r.postjobfree.com

Summary

As an experienced leader in healthcare industry, I bring over 20 years of proven experience in leading diverse teams and managing complex projects. I am known for my transformative leadership style and ability to think outside the box, fostering a positive atmosphere that maximizes productivity. I am a resourceful self starter, analyst, problem solver, and with outstanding communication and organizational skills, I excel in navigating various organizational structures and driving successful transformational initiatives. Professional Qualifications

• Effective Project Management, process improvement, and business development, strategic and operations planning skills i.e DEMAIC, A3, PDSA

• Administrative and cross functional team leadership competences across diverse organizational settings.

• Analytical Skills: Effective problem-solving, critical thinking, and decision-making abilities.

• Coaching, training, and educational expertise

• Regulatory familiarity/knowledge with clinical guidelines (FDA, CAP, CLIA, CLSI, IQMH)

• Clinical and Research Insight: Familiar with clinical and research processes and methodologies. Experience

Dec 2022-

Mar 2024

Clinical Laboratory Manager

Dynacare Laboratory and Health Services, Brampton, Canada

• Collaborated in strategic planning and decision making for the implementation of new instrumentation and workflow processes

• Cooperated in the development and successful implementation of policies and procedures

• Oversaw and ensured all policies and procedures are in compliance with CAP, IQMH, and IJC guidelines. (Contributed to the 2023 CAP internal audit)

• Managed day-to-day operations, including budgeting, resource allocation, and hiring

• Monitored workflow and productivity to ensure timely delivery of accurate results

• Collaborated with chemistry/hematology scientific team, QA/QC team, healthcare providers, and processing team to maintain a fluid workflow and uphold quality patient care. Sep 2022-

Jan 2023

Clinical Laboratory Manager

Donor Services Laboratory (DSL), Hybrid Remote in Las Vegas, US

• Collaborated in decision-making and strategic planning for the successful implementation of new instrumentation and methodologies within the DSL as a start up laboratory

• Provided technical expertise and methodological guidance in establishing robust policies and procedures, conducting method validation, designing protocols, creating SOPs, and troubleshooting

• Managed and directed various activities, including budget allocation, resource management, procurement, and hiring

• Supervised the alignment of policies and procedures with regulatory guidelines and conducted in- process audits to ensure compliance

• Collaborated with the director and QA team to establish comprehensive policies and procedures for monitoring personnel performance, ensuring adherence to regulatory guidelines

• Cooperated with the quality control and quality assurance teams to set up and develop action plans, conducting investigations, implementing corrective and preventive actions (CAPA), and address deviations

2/4

Oct 2020-

Sep 2022

Clinical Laboratory Manager

Mayo Clinic Healthcare System, Minnesota, US

• Developed and executed plans for various DEMAIC/PDSA and JDI projects

• As a member of research and development team, contributed to discover new ways to improve existing products and services and to innovate engaging in mergers and acquisitions and partnerships

• Designed and implemented comprehensive learning plans and strategies for new hires and existing staff

• As a member of Equity, Inclusion, Diversity (EID) panel, contributed to fostering a welcoming environment that embraces individuals from diverse backgrounds, ensuring an inclusive and equitable workplace

• Managed and supervised various activities, including budget allocation, resource management, methodology implementation, and procurement

• Oversaw and ensured all policies and procedures are in compliance with regulatory guidelines

(Successfully managed 2021 CAP inspection with minimal citations)

• Contributed in establishing policies and procedures for monitoring personnel performance, aligning with regulatory standards

• Collaborated with quality control and quality assurance teams to develop action plans, conduct investigations, implement CAPA, and deviation reports.

• Provided technical expertise and methodological guidance for method validation, protocol design, SOPs, and troubleshooting

Oct 2019-

Aug 2020

Clinical Laboratory Manager

Yukon-Kuskokwim Health Corporation (YKHC, YKDRH), Alaska, US

• Led strategic planning and provided guidance during “Lab Move project” for transition to the new hospital building. This included pre and post move space allocation, financial considerations, and HR-related strategies.

• As a member of research and development team, contributed to discover new ways to improve existing products and services

• Led the decision-making and strategic planning for implementing new instrumentations and methodologies in response to the COVID pandemic which had just impacted Alaska and collaborated across hospital departments/interdepartmental to ensure effective response

• As a hiring manager and EID member, implemented strategic initiatives to foster an inclusive and diverse work environment, promoting equity and equal opportunities

• Designed and executed learning plans through e-learning and other educational strategies, enhancing staff skills and knowledge

• Supervised various activities, including budget management, resource allocation, methodology implementation, and procurement

• Ensured policies and procedures are in compliance with regulatory guidelines (Successfully managed 2019-2020 TJC inspection with no citations and 2020 CAP internal audit)

• Supervised operations in collaborations with the quality control and quality assurance teams to address non-conformances affecting quality and processes. Developed action plans, conducted investigations, implemented CAPA, and deviation reports

• Provided technical and clinical expertise and guidance for method validation, protocol design, SOPs, and troubleshooting

Jan 2017-

Nov 2018

Clinical Laboratory Project & Business Consultant

Pastor Medical Laboratory (Remote), Toronto, Canada

• Business project planner and purchasing strategies consultant

• Contributed to the design of performance assessments and action plans, ensuring effective evaluation and improvement

• Provided strategic planning and consultation related to test performance and result optimization

• Provided technical expertise and consulted on point-of-care (POCT) practices

• Provided clinical consultation and supervision of the clinical research team

3/4

Aug 2015-

Jan 2017

Project Manager & Clinical/Technical Laboratory Manager Pastor & Varmaz Medical Laboratories

• Supervised various activities, including budget management, resource allocation, methodologies, and procurement

• Provided strategic guidance for the expansion of a specialty chemistry lab project

• As a member of research and development team, contributed to discover new strategies to improve existing products and services and to innovate engaging in mergers and acquisitions or partnerships

• Supervised procedures and processes, ensuring alignment with regulatory guidelines

• Provided consultation on various point-of-care (POCT) methodologies and practices, to optimize patient care

• Supervised operations in collaboration with the quality control and quality assurance teams to address non-compliances affecting quality processes and conducted investigations, CAPA, and prepared deviation reports

• Provided technical guidance for method validation, protocol design, SOPs, and troubleshooting

• Liaised with physicians, provided expert/scientific consultations regarding laboratory tests Oct 2013-

Jun 2015

Scientist, Researcher

Samuel Lunenfeld Research Institute, Mount Sinai Hospital, Toronto, Canada

• Led a project aimed at designing and implementing innovative methodologies to enhance detection, monitoring, and outcomes for patients with Primary Biliary Cirrhosis, leveraging various molecular approaches, including the Luminex multiplexing platform, ELISA, QPCR, ...

• Provided expert guidance in designing robust protocols and SOPs, ensuring rigorous scientific practices

• Liaised with portfolio manager and research groups, ensuring adherence to Good Clinical Practice

(GCP) and Good Laboratory Practice (GLP) standards

• Ensured timely accomplishment of project deliverables, maintaining focus on quality and efficiency

• Monitored the project budget and effectively communicated with vendors to optimize resource utilization

Sep 2008-

Sep 2013

Research Assistant

University Health Network/Princes Margaret Cancer Centre (Hospital), Toronto, Canada

• Led a project focused on identifying serum and plasma biomarkers for patients with acute myeloid leukemia. These Biomarkers were crucial for monitoring disease activity and predicting relapse. Employed various molecular approaches, including the Luminex multiplexing platform, ELISA, QPCR, and etc

• Acted as a research and development scientist to manage resource and budget planning, which included purchasing Luminex Magpix instrument. This significant investment had a prominent financial impact on both Princess Margaret Hospital (PMH) and Leukemia lab

• Established UHN Bioarchive, a repository for serum and plasma samples from leukemia patients. This initiative facilitated ongoing research and clinical investigations

• Liaised with the research lab manager and research fellows, ensuring adherence to Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards. Aug 2007-

Aug 2008

Medical Laboratory Scientist

CReATe Cord Blood & Peristem Cell Bank Laboratories, Toronto, Canada

• Supervised and provided training to team members on methodologies and protocols, ensuring consistent and high-quality practices

• Collaborated and liaised with management team to address non-conformance issues affecting process and quality. Conducted investigations, implemented CAPA, and prepared deviation reports

• Oversaw status reports preparation, estimated budgets, and resource allocation

4/4

Sep 2006-

Jun 2007

Research Assistant

The Hospital for Sick Children, Toronto, Canada

• As a research assistant, led a project investigating the mechanism of action of a novel cardiovascular/anti-diabetic drug. Additionally, explored signal transduction pathways related to lipoprotein metabolism

• liaised and facilitated communication with other research groups, to implement collaborative research strategies

• Designed and implemented SOPs for the project. Conducted animal studies to advance the understanding of the drug’s effects

Jan 1996-

Aug 2006

Clinical/Technical Laboratory Director

HAKIM & Khatam Clinical Laboratory, Iran

• As a director, provided decisive leadership and strategic planning to optimize process flows within the institution

• Provided technical and methodological guidance for method validation and troubleshooting, ensuring robust scientific practices

• Developed and administrated learning and educational plans and strategies for staff. Fostering continuous growth and excellence

• Supervised and provided guidance in designing protocols and SOPs, assessment procedure for data entry, and resource utilization

• Liaised with physicians, providing expert consultations regarding laboratory testing, enhancing patient care

• Led quality control procedures to address non-conformances that impacted processes and quality and developed action plans and comprehensive reports

• Performed various activities, including budgeting and resource management

• Supervised procedures and processes, ensuring alignment with regulatory guidelines Education

2018-2019 Clinical Research, Pharmacovigilance and Regulatory Affairs Diploma (CRPRA) Academy of Applied Pharmaceutical Sciences (AAPS), Toronto, Canada Final Project: Comprehensive review of methods used for signal detection in drug safety 2015-2015 Project Management (professional courses) University of Toronto, Toronto, Canada

2009-2013 Master’s degree in medical science (MSc, IERF Evaluated # P17-09081/icr) University of Toronto, Toronto, Canada

Thesis: Development and application of serum assay to monitor response to therapy and predict for relapse in acute myeloid leukemia

1988-1995 Doctorate Degree in Clinical Laboratory Sciences (PhD, IERF Evaluated #P17-09081/icr) Ahvaz University of Medical Science and Health Services, Iran Thesis: Iron deficiency anemia and the development and application of a fast and accurate micro- method for Iron and TIBC measurement

Certificates

Clinical Project Management, Drug Safety Management and Pharmacovigilance Compliance, ICH GCP, GMP, TCPS2, Regulatory Affairs and Regulatory Submission, Intellectual Property, Clinical Data Management, Clinical Trials Monitoring, Legislations, Ethics and Good Pharmacovigilance practice, WHMIS

70416-TGS-0 Nevada Supervisory Certificate/NV DPBH Supervisory

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