most updated resume/CV

1. Lidiya Flaksman, MS, RN
709 Pintail ct
Deerfield, IL 60015
(847)840-3209
lidiyaflaks@hotmail.com
CAREER PROFILE
Senior clinical operations professional with rigorous experience in leading large-scale, global
Phase I, II, III and IV studies. Breadth of clinical development experience ranging from small-
specialty CRO’s to large global pharmaceutical, device, and combination drug-device
companies. Accomplished in direct management and training of staff as well as management of
high-performing project teams, using strong interpersonal and problem-solving skills.
Understanding of pharmaceutical, device and healthcare marketing and patient recruitment. In-
depth knowledge of pharmaceutical industry regulations, IND, IDE, and NDA submissions;
proficient with a range of software and medical equipment; expertise in protocol, CRF, and
clinical study report development as well as various EDM, CTM, and IVR systems.
EXPERIENCE
CareFusion Corp. now BD Vernon Hills, IL Sep. 2013 – Present
Senior Manager, Clinical Programs
• Organized comprehensive clinical operations group for combination drug-device products
• Lead small team of dedicated professionals managing and monitoring clinical trials in clinical
areas of Infection Prevention and Interventional Specialties
• Worked with internal and external multi-disciplinary teams on the protocol development and
timeline management
• Developed and implemented unique specialty Pilot, Phase I, and Phase II studies to confirm
activity of topical antiseptics for preoperative skin preparation
• Was responsible for clinical team input on several key development programs for every IND,
NDA, IDE and PMA submission and annual updates
• Selected and managed CRO, study vendors, internal clinical teams, and study sites
• Created collaborative experience in combination product marketing
• Was responsible for entire clinical study process, including: protocol design and development;
communication with opinion leaders; selecting and actively managing vendors and sites;
investigator meetings; contract negotiations; AE and SAE reporting review
• Created and ensured implementation of clinical program and study-specific subject recruitment
programs to enhance subject enrollment and retention based on study product, phase and
subject profile• Redesigned SOPs for Clinical Operations
• Designed and initiated implementation of internal CTMS
• Selected and contracted with new study site vendors
• Developed unique program of site vendor qualification studies specific to Bacterial Load
Reduction Efficacy studies
• Developed, Negotiated, and Managed study budgets and contracts
TAKEDA Pharmaceuticals USA Deerfield, IL June 2012 – July 2013
Senior Clinical Project Manager/Contract
• Led and co-manage several global multicenter Phase III DMT2 studies
• Worked with global, multi-disciplinary team on the protocol development and timelines
management
• Was directly responsible for development and implementation of patient recruitment strategies
based on protocol requirements, types of clinical sites, and subject profile
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2. • Managed CRO, study vendors, internal clinical teams, and study sites
• Worked directly with range of EDMS, IVRS/IWRS and CTM systems
• Collaborated with pharmaceutical marketing on product design
• Was responsible for entire clinical study process, including: protocol design and development;
communication with opinion leaders; selecting and actively managing vendors and sites;
investigator meetings; contract negotiations; AE and SAE reporting review
LUNDBECK, INC. (formerly Ovation Pharmaceuticals, Inc.) Deerfield, IL 2008 - 2012
Senior Clinical Project Manager/Clinical Project Manager
• Led global multicenter Phase III Acute CVA treatment study; developed and managed site
start-up activities to increase number of US sites from 20 to 80
• Managed several consecutive global multicenter Phase III Epilepsy studies (co-managed 30
US sites; personally responsible for 12 sites in India --280 Was responsible for creating and
supporting patient recruitment strategies based on protocol design, clinical sites involved, and
subject profile
• Managed international clinical team: CRAs and CTAs
• Selected and managed CRO, study vendors, internal clinical teams, and study sites
• Worked directly with range of EDMS and IVRS/IWRS and CTM systems
• Had direct experience with data review, analysis, and preparation for NDA submission
• Had direct experience with multiple IND and NDA submissions
• Created and completed ISS document as part of NDA submission
• Collaborated with pharmaceutical marketing on product design and launch
• Was responsible for entire clinical study process, including: protocol design and development;
communication with opinion leaders; selecting and actively managing vendors and sites;
investigator meetings; contract negotiations; AE and SAE reporting review
ASTELLAS PHARMA US, INC. (formerly Fujisawa Healthcare) Deerfield, IL 2004 - 2008
Senior Clinical Research Associate
• Managed several first-in-men Phase I, single-center clinical trials
• Managed multiple international multicenter Phase II (30 sites, 100 subjects), Phase III (50
sites, 280 subjects), and Phase IV(150 sites, 1500 subjects) trials
• Managed CRO, study vendors, internal clinical teams, and study sites
• Was involved with patient recruitment strategies for hospital-based studies
• Had direct involvement with EDMS, CTM, and IVRS systems
• had direct experience with IND and NDA submissions and discussions with FDA
• Designed and developed protocols and handled communication with opinion leaders and
DSMB as well as vendor and site selection and contract negotiations
• Was responsible for organization and presentations at investigator meetings
TAP PHARMACEUTICALS Lake Forest, IL 2002 - 2004
Senior Clinical Research Associate
• Had full responsibility for one arm of a pivotal Phase III trial (100 sites, 600 subjects)
• Implemented quality improvement in the query resolution process for two pivotal Phase III
trials (150 sites, 1000 subjects total)
• Lead CRA-managers on unique Phase I supportive study
CTI NETWORK, INC. Bannockburn, IL 2001 - 2002
Clinical Research Associate
• Monitored sites for compliance with protocol, GCP and FDA regulations
• Acted as liaison between sites, sponsors, CRO, and home health care agencies
• Developed complete study support documentation and training materials
• Trained and supervised field clinical staff
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3. CM HEALTHCARE RESOURCES Northbrook, IL 1998 – 2000
(A subsidiary of Children’s Memorial Hospital)
Field Staff Supervisor
• Managed approximately 30-40 field employees, including hiring, annual performance
reviews, and progressive staff development, for the Mid-West region
• Developed and implemented staff orientation program productivity reports for sales and
marketing department
• Created and implemented pathway-based, outcome-driven disease state management
programs for CHF, Asthma, and Anxiety management
SELECTED THERAPEUTIC AREAS OF EXPERTISE
Infection Prevention; Cardiology & Vascular disease; CNS diseases; Epilepsy;
Ophthalmology; Diabetes/Endocrinology; Hematology/Oncology; Pulmonology; Urology;
Women’s Health
EDUCATION & CREDENTIALS
MS in Managerial Leadership National Louis University 2006
BS in Healthcare Leadership National Louis University 2000
Associate Degree in Nursing School of Nursing #4, Kiev, Ukraine 1988
Current Professional RN License #041-279632
Selected Continuing Education:
BDU Advanced Negotiations
BDU Planning and Leading Projects
BDU Presenting with Impact
Complete CITI GCP and Biomedical research certifications 2017
Clinical Project Management
Managing Global Trials
Clinical Research Recruitment Strategies
Business Writing
Selected Therapeutic Area Training:
Advancements in acute CVA management
Recent research in Epilepsy
Therapeutic advancements in Atrial Fibrillation
SELECTED AWARDS CONFERENECE ATTENDENCE AND PRESENTATIONS
2016 Recipient of OSMT Outstanding Achievement Award
• SCOPE Summit, Miami 2017
• Partnership in BioPharma, Boston 2016
• Outsousing in Clinical Trials, Chicago 2016
• SHEA, Atlanta 2016
• CTI presentation at DIA 2001, CTI Network, Inc. (2001)
• Practical Implications of Airwatch Device, CM Healthcare Resources (2000)
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4. MEMBERSHIP
• DIA (Drug Information Association) – since 2002
• AHA (American Heart Association) – 2006 – 2008
• AES (American Epilepsy Society) – 2009 -2010
• ADA (American Diabetes Association) – since 2010
• BioPharmaPM – since 2010
• HBA (Healthcare Businesswomen’s Association) – since 2011
SELECTED CLINICAL STUDIES
• A Pivotal Study Evaluating the Clinical Performance of the Silver Nitrate-coated
Accelerodesis™ Pleural Catheter Versus the Uncoated PleurX® Pleural Catheter for the
Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions
• A Randomized, Single-Center, Site and Method Clinical Efficacy Evaluation of the Time-
Dependent Antimicrobial Effectiveness of ChloraPrep® Clear 3-mL Applicator and Sage
2% Chlorhexidine Gluconate Cloth for Preoperative Skin Preparation
• Pilot Evaluation of Patient Preoperative Skin Preparation testing Methodologies Using
Two FDA Approved Products
• A Randomized, Single-Center, Blinded, Clinical Efficacy Evaluation of the Antimicrobial
Effectiveness of ChloraPrep® with tint blend Compared to the Currently Approved Hi-
Lite Orange ChloraPrep® and to Sterile Normal Saline for Preoperative Skin Preparation
• Coverage Evaluation of the CHLORAPREP® Preoperative Skin Pprep Applicators
Containing Sterile Drug Solution and Polyolephin Pledget Versus Currently Marketed
CHLORAPREP® Applicators
• A 21-Day, Randomized, Controlled Study to Evaluate the Irritation Potential of a
ChloraPrep® Drug Product with an Alternate Tinted Pledget in Healthy Volunteers,
Using a Cumulative Irritation Patch Test Design
• A 7-Day, Randomized, Controlled Study to Evaluate the Irritation Potential of a
ChloraPrep® Drug Product with an Alternate Tinted Pledget in Healthy Volunteers,
Using a Cumulative Irritation Patch Test Design
• A Randomized, Single-Center, Blinded, Site and Method Clinical Efficacy Evaluation of
the Time-Dependent Antimicrobial Effectiveness of 0.2% Solution of Octenidine
Dihydrochloride in 70% Isopropyl Alcohol compared to ChloraPrep® for Preoperative
Skin Preparation
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5. • A Randomized, Single-Center, Blinded, Pilot Clinical Efficacy Evaluation of the Time-
Dependent Antimicrobial Effectiveness of Various Volumes of 0.2% and 0.4% Solutions
of Octenidine Dihydrochloride in 70% Isopropyl Alcohol for Preoperative Skin
Preparation
• A Randomized, Crossover Study to Measure the Systemic Absorption of an
Antimicrobial Agent After Topical Administration to Intact and Abraded Skin in Healthy
Volunteers
• A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, 24-Week Study to
Evaluate the Efficacy and Safety of Daily Oral TAK-875 50 mg Compared With
Sitagliptin 100 mg When Used in Combination With Metformin in Subjects With Type 2
Diabetes
• A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3
Study to Evaluate the Efficacy and Safety of TAK-875 25 mg and 50 mg Compared to
Placebo and Sitagliptin 100 mg When Used in Combination with Metformin in Subjects
with Type 2 Diabetes
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Determine the
Efficacy and Safety of TAK-875 compared to placebo in Subjects with Type 2 Diabetes
with intolerance to Metformin
• A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-week Study
to Evaluate the Efficacy and Safety of Daily Oral TAK-875 50 mg Compared with
Placebo as an Add-on to Glimepiride in Subjects with Type 2 Diabetes
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to
Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care
in Subjects with Type 2 Diabetes and with Cardiovascular Disease or Multiple Risk
Factors for Cardiovascular Events
• A randomized, double-blind, parallel-group placebo-controlled phase III study to evaluate
the efficacy and safety of desmoteplase in subjects with acute ischemic stroke USA
• Open-label study to assess the safety and tolerability of intravenous carbamazepine as
short-term replacement of oral carbamazeopine in adult patients with epilepsy
• ATryn Immunosurveillance for antithrombin deficiency Registry Program
• Safety and Effectiveness of open-label Clobazam in Subjects with Lennox-Gastaut
Syndrome
• Double-Blind, Placebo-controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5, and
1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome
• A Phase 3, multi-center, open label safety study of RSD1235 (Vernakalant/Kadenza) in
subjects with Atrial Fibrillation
• A Phase 3 prospective, randomized, double-blind, placebo-controlled, multi-center,
tolerance and efficacy study of RSD1235 in subjects with Atrial Fibrillation or Atrial
Flutter
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