原文始发于微信公众号（药时代）：药时代人才宝库 | A Talent in Clinical Trial Management / Operations

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

联系方式：

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