RUXANDRA ISACESCU

e-Resume: https://Ruxandra****.wixsite.com/mysite-1

Cell: 604-***-****

Email: adxc1o@r.postjobfree.com

OBJECTIVE AND EXPERTISE

Bilingual/multilingual Senior Project Manager with over ten years of experience in the life-science and financial industries, directing drug development projects from testing to launching on domestic and global markets. Proven ability to train and lead cross-functional onsite and international teams, managing clinical, operational and regulatory processes. Unique blend of hands-on clinical and operational experience used to organize and manage strategic business and product plans across different therapeutic areas. Problem solver who specializes in negotiating large contracts, skilled in budget management. Phase I-IV human clinical trials for the pharmaceutical, biotechnology and medical devices industry. Some clients include: Glaxo Smith Kline (Bipolar I, Bipolar II), Pfizer (Schizophrenia, Fibromyalgia), Wyeth (Pain Management ), Eli Lilly (Schizophrenia, Depression, GAD, Diabetes), Sanofi (Alzheimer’s), Luitpold (RLS), Pozen (Migraine), Praecis (Alzheimer’s), Johnson&Johnson (Pain Management ).

LANGUAGE SKILLS

• English, French, Spanish, Italian, Romanian: speaking, reading, writing – fluent

• German, Portuguese: speaking, reading, writing – basic COMPUTER SKILLS

• Word, Excel, Power Point, SPSS, Medidata

• EMR, Plexia, Smart ND

PROFESSIONAL EXPERIENCE

MEDICAL and PSYCHOLOGICAL

Clinical Operations Leader (02/2012-09/2012)

Parexel International, West NY, NJ

• Led clinical, operations, vendors and regulatory teams to launch a new product on the market

• Initiated and Planned Projects : managed study start-up activities and developed study plans, tools and forms

• Implemented, controlled and evaluated projects : provided leadership and direction to project team members and resolved issues

Clinical Development Consultant (10/2010-12/2010)

Chugai Pharma USA (Roche Group), Berkeley Heights, NJ

• Developed Standard Operating Procedures\

• Reviewed clinical data: SAEs, Conmeds

Global Project Manager (04/2009-10/2010)

Pfizer, NY, NY

• Developed, negotiated and managed budgets and timelines in order to increase cost efficiency by 10%

• Planed and developed strategies of crosspollination of new and existing products to emerging markets (Latin America)

• Improved processes, managed and prioritized work across multiple projects with different stakeholders, simultaneously.

• Led the regulatory approval processes across the region Global Project Manager (01/2008-06/2009)

Wyeth, Madison, NJ

• Implemented new patient recruitment strategies in order to obtain a 15 % improvement in patient recruitment timelines

• Selected and managed vendors that would take over parts of the clinical studies in order to obtain a 25% cost efficiency

• Reviewed vendor proposals and presented comparison materials for vendor selection

• Developed, negotiated and managed budgets and timelines Vendor Manager (09/2007-12/2007)

Schering Plough, Kenilworth, NJ

09/2007-12/2007

• Selected best vendors for each department in order to improve the quality of services across departments and obtain a 10% improvement in cost efficiency

• Selected vendors based on new qualification standards that I created

• Revised SOWs

• Revised & approved amendments, change orders, invoices Global Project Manager (01/2007-08/2007)

Johnson & Johnson, Raritan, NJ

• Developed new strategies of closing studies and managed to eliminate timeline extension requests from the vendors

• Developed strategies for a 15% improvement of the recruitment on studies for different therapeutic areas

• Managed clinical aspects for all stages of clinical trials: reviewed and made changes to ProtocolsServe as a primary resource for clinical and scientific information

• Developed templates for Case Report Forms, Informed Consent Forms, Source Data Verification Forms International Project Manager (01/2006-12/2006)

ALTANA Pharma, Florham Park, NJ

• Supervised site selection & IRB approval process

• Prepared Monitoring Plans and review monitoring reports

• Supervised finalization of Protocols, ICFs, CRFs, SDVF

• Trained site staff on protocol, CRF completion guidelines (using EDC), SAE reporting procedures, supply request and record procedures – Power Point presentations

Safety and International Project Manager (09/2005-12/2005) Dimensional Health Care, Cedar Knolls, NJ

• Presented new recruitment strategies to sponsors in order to improve recruitment by (10-20)%

• Coordinated 200 sites & 14 CRAs in Canada

• Acted as Business Developer and first point of contact with sponsors

• Managed site selection & IRB approval process and shipment of study materials; trained site staff on protocol, CRF completion guidelines (using EDC), SAE reporting procedures, supplied request and recorded procedures – Power Point presentations

International Project Manager (04/2005-08/2005)

AstraZeneca, Wilmington, DE

• Coordinated activity of 10 Country Managers and 18 CRAs in Latin-America; coordinated monitoring of 159 investigator sites in Latin America as part of a multiple center project

• Coordinated monitoring of 159 investigator sites in Latin America as part of a multiple center project

• Conducted site budget negotiations and Investigator contracting

• Ensured proper supply & shipment of clinical materials to study sites Global Clinical Trial Manager (03/2004-03/2005)

Global Medical Institute, Princeton, NJ

Acted as key client contact & managed all aspects of project execution

• Presented studies to Private practices and Hospitals in the area, in order to get sites signing up for the studies

• Hired, trained and coordinated site staff on protocol, CRF completion guidelines (using EDC), SAE reported procedures, supply request and record procedures – Power Point presentations

• Data listings review and clean up

Medical Science Liaison (01/1997-12/1998)

Medtronic, Bucharest, Romania

• Visited hospitals and private practices and supplied the products they needed

• Organized individual and group product presentations

• Participated in conferences and trainings on new products Psychology Counsellor (10/19-12/2019)

Yale Clinic, Vancouver, BC

• Assessments and psychotherapy addiction patients Psychometrist (08/2019-10/2019)

Able Clinic, Vancouver, BC

• Performing psychometric assessments

Tutor and Study Advisor (11/2019-Present)

ROMARG LLC, Vancouver, BC

• Coaching and tutoring students on methods of efficient learning, tailored on each individual needs and capacities Medical Office Assistant

(12/2018)

VGH Eye Care Center

• Optometric assessments

• Performing retinal scans, preparing for the eye exam Medical Office Assistant

(10/2018)

Vancouver Pediatric & Allergy Center, Vancouver, BC

• Providing reception duties

• Assisting physicians with patient consults

Medical Office Assistant/Patient Interviewer

(09/2018)

Vancity Ear, Nose & Throat, Vancouver, BC

• Conducting patient interviews

• Assisting physician with patient consults

Psychological & Medical Assessments / Translator/Interpreter

(05/2017-05/2018)

RomArg LLC

Languages: Spanish, French, Italian, Romanian

• Interpreting for patients in hospitals, medical & psychological offices/clinics (patient interviews and assessments)

• Phone teleconferences: corporate meetings, Immigration (Border Offices), service providers (different fields) Psychotherapist (01/2017-04/2017)

Medex Assessments, Toronto, ON

• Performed psychological assessments, establish diagnosis and recommendations for treatment

• Provided psychotherapy (CBT – cognitive behavioral therapy)

• Developed client treatment plan and progress notes Case Manager (11/2016-12/2016)

Spinehealthcare Clinic, Toronto, ON

• Wrote medical and psychological case reports

• Interviewed and assess clients on medical and psychological conditions

• Met with hospital and other therapeutic facilities representatives (psychotherapists, -Spoke with (surgeons, physiotherapists, school counselors) and discussed client interventions Medical Interviewer-Call Center (06/2016-07/2016)

Keyfacts Interviews, Toronto, ON

• Collected medical information for insurance claims FINANCIAL

Personal Banker (02/1999-02/2004)

Royal Bank of Canada, Vancouver, BC

• Managed client portfolios for mortgages, credit lines, credit cards, mutual funds investments, fixed term investments

• Negotiated plans for debt issues and created payment plans Front desk reception (04/2019 temp)

Royal Concierge, Vancouver, BC

• Managing reception and security issues for residential building Accounting Assistant/Bookkeeper

(08/2018)

Huamali & Associates, Burnaby, BC

• Assisting with bookkeeping operations

• Providing reception operations

Reception Manager

(07/2018-08/2018)

Strata, Vancouver, BC

• Managing reception and security issues for residential building Customer Service Representative/Cashier

(06/2018-07/2018)

Winners, West Vancouver, BC

• Providing customer advise and cash operations

Insurance Advisor-Call Center (01/2016-04/2016)

Royal Bank of Canada, Toronto, ON

• Advised clients on insurance products

Monitor (09/2015-11/2015)

Precise Parklink, Toronto, ON

• Provided telephone customer support

Client interviewer-call center (04 / 2014-11 / 2014) Greenwich Associates, Montreal, QC

• Interviewing clients in different languages

EDUCATION

Medical:

• Medical Doctor Degree - University “Carol Davila”, Bucharest, Romania (1997)

• PhD Clinical Psychology (candidate) - Walden University, Minneapolis, MN (2014)

• NAPSR Certificate No: 615022014 (2015)

• Certified Fitness Trainer Certificate – ISSA, CA (2014)

• CPR Certificate – Red Cross, NJ (2014)

• Clinical Research Professional Development Certificate - Kriger Research Centre Inc. - NY, USA (2004)

-Clinical Trial Monitoring and Research Site Coordination

-ICH and GCP guidelines

Financial:

• Underwriter Life and Health Insurance Certificate – LOMA (2018)

• Accounting (2004 - part of the MBA program)

• Professional Financial Planning Certificate (2003)

• RBC Creditor Insurance Certificate (2002)

• Canadian Securities Certificate (2001)

• Investment Funds in Canada Certificate (2000)

• Languages:

Spanish Diploma Cervantes Institute (1997)

French Diploma French Institute (1998)

Italian Diploma Italian Institute (1998)

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