Clinical Research Manager

Firas Dandachli, MD, MSc

**** ** *********** ****, ********* 1904

Montreal, Quebec, Canada, H3H 2N3

(514) 559- 1636

**.*********@*******.**

Profile

Experience working with multidisciplinary teams & cross-functional collaborations

(prospective & retrospective projects, pre-clinical and clinical trials)

Highly-developed communication & presentation skills with the ability to effectively simplify & communicate complex material to a diverse array of audiences

Strong network with Key Opinion Leaders (KOLs), Academic Health Care Professionals

(HCPs), Professional associations & other key stakeholders in different area of disease

Experience with clinical research programs, Investigator-Initiated study & successfully managing projects from start to finish, including publications

Strong knowledge of GCP, SOP, Rx&D code & Healthcare Compliance policies

Excellent team player interested in sharing knowledge & coaching/educating colleagues and peers

Excellent analytical, project management, facilitation & negotiation skills to influence decision making

Self-starter, able to multitask & follow through while working independently in a field- based role

Knowledgeable of the Pharmaceutical Advisory Board meetings

Detailed computer skills in Microsoft Office (Word, Excel, PowerPoint, Outlook), Quickbook, Reference Manager, Endnote

Languages spoken & written: English, French, Russian

Solid knowledge in the therapeutic areas of: Cardiology, Immunology, Autoimmune Disorders, Medical Oncology, Orthopedic Oncology, Chemotherapy & Radiotherapy Work experience

National Clinical Research Associate February 2016 –Present Clinical Development Specialist

Area of coverage (Canada & USA)

Cardiology (Arterial Hypertension, Atherosclerosis, Medical Devices, Diabetes, Vascular surgery) Radiology & Neurology

Quintiles Transnational Corp. Partner to Boston Scientific

Act as an Intermediate between the Sponsors and PIs, collaborate closely with the Global

& Local Scientific Managers

Perform Site Qualification, Selection, Initiation, Monitoring & Close-Out visits in accordance with the contracted scope of work & Good Clinical Practice

Provide monitoring visits and site management for a variety of protocols, sites & therapeutic areas

Administer protocol & related study training to assigned sites & establish regular lines of communication with sites to manage ongoing project expectations & issues

Evaluate the quality & integrity of study sites practices related to the proper conduct of the protocol & adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Team Lead & Global Manager 2

Manage the progress of assigned studies by tracking regulatory submissions & approvals, recruitment & enrollment, case report forms (CRFs) completion & submission, data query generation & resolution

Create & maintain appropriate documentation regarding site management, monitoring visit findings & action plans by submitting regular visit reports, generating follow up letters & other required study documentation

Provide assistance to less experienced Clinical Staff Clinical Research Associate, Data Manager June 2012 – January 2016 Division of Oncology

McGill University Health Center

Working with multiple Health Centers in Canada & USA Responsibilities:

Possess a strong knowledge of all oncological diseases, including related disease states

Continuously upgrade disease & treatment knowledge used in the area of oncology, as well as other therapeutic options used within relevant disease states (Chemotherapy, radiotherapy and surgery)

Review & critique scientific publications & clinical literature in order to discuss the medical therapeutic information with Academic Health Care professionals

Collect, generate & analyse data about the tumors (type, localisations, size and type of surgical procedures), clinical outcomes and the impact of surgery and treatment (chemo and radiotherapy) on functional ability

Provide medical/scientific review (e.g. slide presentations) & discuss with HCPs on emerging cases (Tumor Board Meeting)

Provide medical/scientific review, supervise & train Residents & International Medical Doctors for clinical research projects; support projects from conception to completion; participate in statistical analysis, data interpretation & writing for scientific journals

Facilitate communications with research sites in Canada and USA for ongoing research projects being compiled & preparation of information for newsletters, websites, blogs & drafting correspondence for patient education & support groups

Develop & provide effective clinical presentations (e.g. slide presentations) in the national and international congresses

Define & write scientific research protocols, assist in development & management of necessary documentation for clinical trials (e.g. study protocols, informed consent forms, case report forms (CRF), study reports)

Prepare & complete regulatory documents, submit & track requests for McGill’s Research Ethics Committee approval

Identify, analyze & evaluate studies to ensure that clinical trials comply with the research protocol, regulations & ICH guidelines including (GCP) & Standard Operating Procedure

(SOP)

Plan, execute & review financial project agreements among principal stakeholders

(McGill’s Chief of Orthopedic Oncology, McGill principal investigators, staff physicians, other principal investigators in Canada & USA)

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Scientific Liaison Specialist January 2008-2011

Responsible for Preclinical and Clinical Study

Montreal Heart Institute (MHI) & St. Luc Hospital (SLH) University of Montreal, Canada

Area of expertise:

Autoimmune disorders (Rheumatoid Arthritis and related disease states)

Possess in-depth knowledge & a deep understanding of Autoimmune Diseases

(Rheumatoid Arthritis) - current & future trends relating to the pathophysiology of autoimmune disorders & to the development of therapeutic protocols

Collect, analyse & provide scientific review of competitive intelligence, new pathways & new modalities in autoimmune disease treatment including related disease states

Study & identify new receptors other than the Classical Receptor of RA, identify a novel therapeutic tool for the prevention/treatment of RA associated Thrombosis

Review, present & disseminate clinical & scientific data in a balanced, unbiased manner to Key Opinion Leaders & Health Care Professionals, in a group and one-on-one settings

Provide medical/scientific review and disseminate published & unpublished data for Immunoinflammatory Mediator implicated in the pathogenesis of Rheumatoid Arthritis & related disease states

Collect medical insights & intelligence gathered from scientific exchange with thought leaders as well as interpret & communicate relevant information in order to define & develop new therapeutic opportunities

Train research students to broaden their medical knowledge in order to enable them to properly interpret & analyse complex scientific data, place them in a clinical context & understand the application of fundamental data on human health Thrombosis and Homeostasis (Anti-platelet and Anti-coagulant Therapies)

Possess in-depth knowledge & a deep understanding of the pathophysiology & treatment of cardiovascular & Hematological diseases

Act as a scientific resource person for providing scientific review & clinical literature, discussing at the highest scientific level information (basic and clinical) related to the pathophysiology of Arterial Thrombosis formation with

Compare the effect of current anti-platelet drugs used & those in development with newly emerging therapies in the prevention of Coronary Artery Disease to Cardiologists & Hematologists (e.g. slide presentations)

Work collaboratively with Clinical Development Personnel in order to identify opportunities for Investigator Initiated Study and secure & monitor the Investigator’s participation

Facilitate research publication of articles which support the scientific business position of the company

Collaborate with other MHI laboratories on Stem Cell Research (purification of stem cells in the formation of arterial thrombosis and the implication of stem cells in diabetic disease)

Evaluate feasibility, facilitate submission & ensure that the studies comply with research protocols, regulations & ICH guidelines including Good Clinical Practice (GCP) & Standard operating Procedure (SOP)

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Education and Training

May 2013 Clinical Research Certification Program

Standard Operation Procedure SOP

Good Clinical Practice GCP

McGill University, Montreal, Canada

January 2008 - August 2010 Master’s Degree in Immunology, MSc. Montreal Heart Institute,

University of Montreal, Canada

Thesis: “An Anti-von Willebrand Factor Aptamer Reduces Platelet Adhesion among Patients receiving Aspirin and Clopidogrel in an Ex Vivo Shear-Induced Arterial Thrombosis”

May 2008 Training course on animal-ethics and mice-handling University of Montreal, Canada

September 2000- July 2006 MD, Faculty of Medicine

Belarusian State Medical University

Belarus

Peer Reviewed Publication

1. Use of Ligament Advanced Reinforcement System tube in stabilization of proximal humeral endoprostheses. World J Orthop. 2016 Apr 18;7(4):265-71. doi: 10.5312/wjo.v7.i4.265. eCollection 2016. Stavropoulos NA1, Sawan H1, Dandachli F1, Turcotte RE1

2. Prophylactic antibiotic regimens in tumour surgery (PARITY): a pilot multicentre randomised controlled trial. Bone Joint Res. 2015 Sep; 4(9): 154-62. PMID: 26423 McGill University Health Centre (Montreal, Quebec): R. Turcotte, K. Goulding, F. Dandachli, and G. Matte;

3. An anti-von Willebrand Factor aptamer reduces platelet adhesion among patients receiving aspirin and clopidogrel in an ex-vivo shear-induced arterial thrombosis. Clin Appl Thromb Hemost 2011; 17(6):E70-8. D. Arzamendi, F. Dandachli, JF. Théorêt, G. Ducrocq, M. Chan, W. Mourad, JC. Gilbert, RG. Schaub, JF Tanguay, Y. Merhi Electronic publication on November 15, 2010; PMID 21078615 Drs Arzamendi and Dandachli contributed equally to this work 5

Abstract accepted

1. Utilizing Standardized Uptake Value (SUVmax) on FDG-PET/CT for the Prediction of Survival of Patients with Soft Tissue Sarcoma

Rima Tulbah MD1, Firas Dandachli MD2, Robert Turcotte MD2, Marc Hickeson MD1 Society of Nuclear Medicine and Molecular Imaging (USA) 2. Limb-Sparing Surgery with Vascular Reconstruction for Malignant Lower Extremity Soft Tissue Sarcoma

Laura A. Davis1MD, Firas Dandachli2MD, MSc, Robert Turcotte2MD, Oren K. Steinmetz1MD DOI: http://dx.doi.org/10.1016/j.jvs.2014.08.041 Journal of Vascular Surgery Conference Communications – National & International October 2014 Poster Presentation: Annual Investigator’s Meeting Berlin, Germany

September 2014 Oral presentation: Annual General Meeting Canadian Society for Vascular surgery

Toronto, Canada

May 2014 Oral Presentation: Annual Meeting of the European Musculoskeletal Oncology Society (E.M.S.O.S)

Vienna, Austria

June 2009 Poster Presentation: Montreal Heart Institute Research Day Montreal, Canada

May 2009 Poster Presentation: Canadian Congress of Cardiology Edmonton, Alberta, Canada

April 2009 Poster Presentation: European Congress of Cardiology Barcelona, Spain

March 2009 Oral Presentation: International Society of Thrombosis and Hemostasis Congress

Boston, Massachusetts, USA

February 2009 Oral Presentation: Clinical Research Seminar Université de Montréal, Canada

Other Professional Activities

2008 – Present Canadian Red Cross: First Aid assistance at various events; Canadian Red Cross Ottawa, Canada

References

Available upon request

Contact this candidate