An Experienced Talent in Clinical Trial Management and Operations
Looking for a Director / Associate Director Level Position in Clinical Operations within Clinical Research
一位具有丰富的临床试验管理与运营经验的人才
寻找临床研究方面的临床运营主任/副主任等相关职业发展机会
EDUCATION
Bachelor Degree in Science (Biochemistry), 1995
University of Sherbrooke, Sherbrooke, Quebec, Canada
Certificate (on-line) in Project Management, on-going
McGill University, Montreal, Quebec, Canada
THERAPEUTIC EXPERIENCE
PROFESSIONAL EXPERIENCE
A major CRO in Canada
Associate Director, Global Project Management, Mar 2017 –present date
Senior Project Manager, Global Project Management, Nov 2015– Feb 2017
Associate Director, Global Project Management (Hematology / Oncology):
Plan and implement, to achieve, anticipated and unexpected project deliverables.
Analyze and oversee cost, personnel hours and project needs to determine the most cost effective and efficient means to run and complete projects successfully on time, to agreed quality standards and within budget while meeting the Customer’s needs and adhering to the contract.
Delegate assigned responsibilities to Project Team Members
Have regular and proactive liaisons with Department Heads to optimize performance and utilization of the project team members and project-related resources.
Anticipate potential issues and escalate appropriately/pro-actively to their Franchise Director
Train Project Manager / Project Team Members and follow up on their performances
Act as Customer’s escalate point throughout study
Molecular Neuro lmaging, New Haven, CT, USA
Director, Project Management, May 2015 –Oct 2015
Director, Project Management:
Lead and coordinate the sponsor’s request for proposal (RFP) and bid defense process
Propose, negotiate and maintain study budget and payment milestones
Participate in sponsor’s CRO/Vendor regular/ad-hoc meetings to provide expert’s advice on PET imaging services
Present at the sponsor’s Investigator Meetings.
Assist management in determining appropriate strategies for deliverables
Hands-on on daily/weekly updates internal databases and report back to sponsors
A MNC Pharma, Shanghai, China
Global Studies Lead, Global Product Development, Feb 2011 – Apr 2015
Global Studies Lead, Global Product Development:
Lead the global cross-functional teams to ensure progress and compliance of global / regional (APAC) phase 3 clinical trials (Oncology, Inflammation, Neuroscience) with the ability to identify issues pro-actively and adapt / readjust to frequent changes of portfolio and product life cycle
Coordinate all aspects of the investigational drugs supply chain
Coordinate complex import / export process of lab kits and bio-samples
Coordinate review of relevant study documents including protocols, informed consents, case report forms (CRFs), monitoring plans, investigator brochures, and clinical study reports
Create and Maintain study master timelines and budget ($15M-$25M/clinical trial) and assists Management in determining appropriate strategies for deliverables (in/outsource)
Manage and Track team member performance including Global/Country Study Managers, Global/Country StudyAssociates to ensure operation effectiveness
Select and manage CRO/Vendors’performance
Maintain Trial Master File (TMF) following corporate Inspection Readiness guidelines
Pfizer Canada, Kirkland, Quebec, Canada
Clinical Operations Lead, Study Management, Jun 2006 – Dec 2010
Clinical Operations Lead, Study Management:
Core member of the global cross-functional teams to manage all operational aspects of late global / regional phase 3-4clinical trials (Oncology, Ophthalmology, Erectile Dysfunction, Infectious Disease, Neuroscience), with the ability to identify issues pro-actively and adapt / readjust to frequent changes of portfolio
Coordinate and supervise all aspects of the investigational drugs supply chain
Review essential/relevant studydocuments including protocols, informed consents, case report forms (CRFs), monitoring plans, investigator brochures, and clinical study reports
Maintain study master timelines and budget
Maintain Trial Master File (TMF) following corporate Inspection Readiness guidelines
Manage regional / local CRO/Vendors’ performance
Algorithme Pharma, Montreal, Quebec, Canada
Clinical Study Manager, May 2001 – May2006
Clinical Study Manager:
Manage all operational aspects of phase1 (First in Human/PK/PD/Dose escalation) and Bioequivalence clinical trials; leading both in-house clinical team and third-party contractual vendors
Review essential/relevant study documents including protocols, informed consents, case report forms (CRFs), monitoring plans and clinical study reports
Maintain study master timelines and budget
Revise SOPs; Maintain Trial Master File (TMF)
Train clinical team for Inspection Readiness
Pfizer Canada, Kirkland, Quebec, Canada
Quality Assurance, Clinical Lead,Contract, May 2000 – Apr 2001
Quality Assurance, Clinical Lead (contractual position):
Prepare routine audit plan and submit to Management for approval
Conduct on-site live audit at CRO/vendor facilities
Review essential/relevant study documents and publish audit report
Follow up on CAPAs
Anapharm Inc, Quebec City, Quebec, Canada
Clinical Study Manager, 1998 – Apr 2000
Clinical Study Manager:
Manage all operational aspects of Bioequivalence clinical trials for generic formulations
Review essential/relevant study documents including protocols, informed consents, case report forms (CRFs) and clinical study reports.
Maintain study master timelines and budget
The Montreal Heart Institute, Montreal, Quebec, Canada
Clinical Study Coordinator, 1996 - 1998
Clinical Study Coordinator:
Scheduling and coordinating all patients’ visits for multiple sponsor’s protocols in the Heart Failure Unit
Perform data entry into CRFs and receive CRA’s monitoring visits
Perform lab sample processing and other non-clinical study-related tasks
PROFESSIONAL DEVELOPMENT
Trained in Clinical Data Monitoring
Trained in Neuro-Psychological Assessment of cognitive function used in clinical trials for Alzheimer’s disease, Bipolar and Addictions
Trained to perform clinical ECG and recognize heart failure primary signs and symptoms
Trained in Visual Impairment Assessment and perform routine Visual Acuity tests
LANGUAGES
Fluent in English and French; Conversational Italian, Japanese, Vietnamese and Chinese Mandarin
Global living experience (America, Europe, Asia,Africa) and Work experience (America, Asia)
CLINICAL TRIAL EXPERIENCE
Oncology: Phase 1B / Phase 3 Multicenter Studyof XXX in Combination Regimens that Include an Immune Agonist, Epigenetic Modulator, CD20 Antagonist and/or Conventional Chemotherapy in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Oncology: A Randomized Phase 2 Study of the Anti-Angiogenesis Agent XXX in Combination with Gemcitabine in Patients with Chemotherapy Naive Advanced Pancreatic Cancer Preceded By a Phase 1 Portion
Oncology: A Randomized, Double-Blind Phase 3 Study of Gemcitabine Plus XXX versus Gemcitabine Plus Placebo for the First-Line Treatment of Patients with Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Oncology: A Phase 3, Randomized Study of XXX versus Interferon-Alfa as First-Line Systemic Therapy for Patients with Metastatic Renal Cell Carcinoma
Oncology: Phase II, Single Arm Trial of Combination XXX and Gemcitabine in Sarcomatoid and/or Poor-risk Patients with Metastatic Renal Cell Carcinoma
Oncology: A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy and Safety Study of XXX in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer Treated With Erlotinib
Oncology: Open-label Study of XXX Maintenance Therapy (XXX®) with or without Pemetrexed After First-line Chemotherapy With XXX-Cisplatin-Pemetrexed in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer (NSCLC)
Oncology: Open-labeled, Randomized, Multicenter Phase III Study of Adjuvant Chemotherapy Comparing XXX plus Cisplatin with Cisplatin Regimen in Malignant Pleural Effusion of Advanced Stage Non-Small-Cell Lung Cancer Patients
Oncology: A Randomized, Double-Blinded, Placebo-Controlled, Multicenter PhaseIII Study Comparing XXX plus Carboplatin/Paclitaxel versus Placebo plus Carboplatin/Paclitaxel in Patients with Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer who Have Not Received Prior Chemotherapy for Advanced Disease
Ophthalmology: Long-Term Non-Interventional Study(AB Study) To Investigate the Efficacy and Safety of XXX® In Patients with Neovascular Age-Related Macular Degeneration under Conditions of Routine Clinical Practice
Ophthalmology: A Prospective, Open-Label Multi-Center Trial Evaluating The Safety And Efficacy Of 0.3 Mg/Eye XXX Intravitreous Injection Given Every 6 Weeks For 54 Weeks In Patients With Small Neovascular Age-Related Macular Degeneration (AMD) Lesions
Genitourinary: A Multi-Center, Parallel Group, Flexible Dose Trial with A Double-Blind, Randomized, Placebo-Controlled Phase Followed By an Open-Label Phase to Assess the Impact of XXX on the Sexual Satisfaction of Men with Mild Erectile Dysfunction
Respiratory: A Multicenter, Long-Term Extension Study to Assess Safety of XXX in the Treatment of Subjects Who Have Completed Study XXX
Mental Disorders: A Three-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Add-On Oral XXX in Subjects with Acute Mania Treated With Lithium or Divalproex
Mental Disorders: A Six-Week, Randomized, Double-Blind, Multicenter, Fixed-Flexible Dose, Placebo-Controlled Study Evaluating the Efficacy and Safety of Oral XXX in Outpatients with Bipolar I Depression
Nervous System: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Smoking Cessation with XXX Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Nervous System: A Phase II/III Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of 2 Potential Disease-ModifyingTherapies in Individuals at Risk for and With Dominantly Inherited Alzheimer's Disease
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