Ruth Antoine

*** * ********* ***** ***** NJ *****

Email: acgbxk@r.postjobfree.com

SUMMARY

. 10+ years of clinical research experience

. 6+ years of clinical/project management and CRO/vendor/site management

. 5+ years direct personnel management

. Domestic and global experience in Phase I-IV trials within: Medical

Device, Pediatrics, Neurology, Respiratory, Gastroenterology, Oncology

(solid and liquid cancer), Allergy, Infectious Disease, Nutrition and

Weight Loss, Neonatology, Family Medicine, Healthy Volunteers, Obesity,

and Hematology

. Prominent leadership and managerial skills in study management from start

up to successful agency submission

. Experience in regulatory and compliance requirements for clinical

research, including but not limited to US CFR, EU, ICH and GCP

PROFESSIONAL EXPERIENCE

Shionogi Inc.

November 2012 to Present

Florham Park New Jersey

Senior Study Manager Clinical Operations and Medical Affairs- Phase I-IV

Indication: Allergy, Infectious Disease, Urology, Pediatric, and

Neonatology

Tasks & Responsibilities:

. Oversee and lead strategic planning and management of multiple phase I

- IV global clinical trials projects

. Serve as internal clinical liaison between multiple global regional

heads to collaborate efforts towards the development, management, and

maintenance of study deliverables

. Serve as a leader in selecting CRO and vendors by managing RFP

process, proposals and contracts for implementation of new clinical

programs

. Direct and manage external partners, CROs, and vendors to ensure the

timely and cost-effective implementation of clinical studies

. Directly manage CRO on daily basis to ensure all study milestones

(site selection, recruitment, data monitoring and cleanliness, data

listing review, query resolution, database lock, final data listings,

CSR completion) are met in according to company and clinical program

objective

. Manage all operational aspects including: study design, protocol

development, feasibility, investigator meeting planning, study start

up, execution, closure and CSR generation of clinical studies

. Lead Clinical Operations initiative and incorporate past lessons

learned to develop innovative processes for new studies

. Development/management/reconciliation of overall study budget(s) by

managing scope of work, reviewing and approving study invoices

. Establish and maintain effective communication/collaboration with

domestic and international cross functional peers such as:

Pharmacovigilance, Drug Supply, Quality Assurance, Regulatory Affairs,

Legal, Medical Writing, Biostatistics and Data Management to support

achievement of study goals

. Review and coordinate with cross functional study team members to

finalization study plans such as: Statistical Analysis Plan,

Recruitment/Retentions Plan, Monitoring Plan, Safety Monitoring Plan,

Data management Plan, Communication Plan

. Complete risk analysis by coordinating with groups such as finance,

clinical supplies, and legal to identify and resolve obstacles to

assure program progress and completion

. Responsible for reporting study/program performance and status to

executive management

. Oversee resource requirements (time, financial, manpower) within

clinical research by determining the outsourcing strategy for a

clinical program and assist the senior director in developing budgets

for outsourced task

. Contribute to talent and career development of Shionogi clinical team

members through training and mentoring of CTAs, CRAs and junior

Trial Managers

Eisai Medical Research Feb

2012- November 2012

Woodcliff Lake New Jersey

Senior Study Manager Medical Affairs (Consultant) - Phase II

Indication: Oncology Breast Cancer

Tasks & Responsibilities:

. Study management leader in the development and execution of clinical

trials in accordance to overall compound development plan

. Supervise CRO to ensure clinical study is completed with high quality

of standard

. Manage study start up, execution and completion by managing day to day

activities of clinical study

. Collaborate with project teams and business operations to develop

clinical outsourcing specifications to facilitate the selection of high-

quality clinical vendors

. Responsible for organizing functional teams to coordinate the

development and finalization of key study documents including

protocols, case report forms, informed consent documents, study

management plans and final clinical study reports

. Oversee development, management, and maintenance of study deliverables

through collaboration with cross functional team groups such as: Data

Management, Biostatistics, Medical, Clinical supplies and QA to ensure

study is conducted within company policies, procedures, quality

standards and GCP guidelines

. Coordinate with finance to supervise the development, management and

tracking of clinical budgets

. Work with clinical supplies group to complete investigational product

supply forecasting/management and study-level IP reconciliation

. Manage routine data snap shot milestones for scientific and medical

publications

. Manage clinical monitoring quality and adherence to established

processes and plans

. Co-monitor and complete routine audits for data quality, regulatory

compliance, and patient safety issues

. Team leader and driver in facilitating the development and

implementation of remedial activities when necessary for trial success

. Develop and implement project specific training programs and training

materials for internal and external staff

. Generate and present protocol clinical study status reports for

executive management

. Identifying risks and challenge that may hinder clinical trial and

escalate them to executive members

Pfizer Pharmaceuticals

November 2010 - Feb 2012

New London, CT

Global Study Manager (Consultant) - Phase II

Indications: Oncology Leukemia/Hematology/CML

Tasks & Responsibilities:

. Supervise and manage the day to day activities for multiple global

studies by serving as global leader to regional team members

. Responsible for ensuring that the operational aspects of a clinical

study meet time, quality & cost targets consistent with the Clinical

Development Plan

. Work with cross functional team members to create study plans and

manuals for clinical study

. Manage day to day activities for compassionate use program of

investigational product

. Perform trainings and provide project specific oversight to CRAs, CTA,

COLs

. First contact person for protocol issues and questions from CRA's, KOL,

Investigators and IRB

. Collaborate with finance to approve monthly invoicing by reconciling

invoices against approved study budget

. Oversee of investigational product initial supply and resupply

. Lead global and regional team meetings and provide executive leaders

with metrics and study status

. Provide assurance that studies are conducted in compliance with GCP,

relevant SOPs, and regulatory requirements; Responsible for study

management components of inspection readiness for all aspects of the

study conduct and oversee cause audit observation, response, and

reconciliation

. Collaborate with clinical and regulatory to determine significant

objectives and requirements of each deviation, nonconformance and CAPA

investigations

Eisai Medical Research

March 2008 - November 2010

Woodcliff Lake New Jersey

Manager of Clinical Operations (Consultant) -Phase III

Indication: Gastroenterology

Task & Responsibilities:

. Lead global team towards achieving clinical program goals by providing

strategic and operational leadership for studies to ensure delivery on

time, within budget, and of high quality in compliance with ICH/GCP

. Full management of CRO/Vendors and of study activities from study start

up to successful FDA submission within time/cost quality

. Develop study management processes for study team to help manage clinical

studies

. Work with Stats, Data Management in preparation of activities before,

during and after database lock

. Review full patient profile to assess medical, adverse events,

concomitant therapies, safety and efficacy endpoints. In addition but not

limited to: laboratory results, AE follow up, drug accountability,

inclusion and exclusion criteria and etc.

. Co-monitored study sites and Perform pre-FDA inspection at study site

for readiness for FDA inspection

. Work directly with QA, regulatory department heads, and clinical study

staff to ensure study files are FDA inspection ready

. Present study status to upper management weekly

. Assist in preparation for NDA submission

. Managed clinical assistants and junior clinical staff

Johnson & Johnson Research & Development

April 2007 -March 2008

Bridgewater, NJ

Clinical Trial Manager (Consultant) - Phase III

Indications: CNS and Internal Medicine

Task & Responsibilities:

. Managed the daily operations of the Phase III clinical program including

management of CRO, and study enrollment activities

. Manage, prepares, and reconcile budgets and financial forecasts and

present financial status at clinical team meetings

. Help to create/negotiate CTA's with contract/grant associate and local

management

. Assist with control of outsourced activities, CROs, central laboratories,

site budgets, vendors, etc.

. Perform UAT on trial related external systems and related manuals (such

as IVRS)

. Create local country recruitment/trial plan and monitoring guidelines

. Set up the Local Administration File and work with IDA to make sure all

regulatory documents are received for study start up

. Monitor need for additional drug and non-drug supplies as well as re-

labeling of study drugs or drug transfer if required

. Update internal Clinical Trial Management System as needed on assigned

studies (e.g. track enrollment, patient scheduling, monitoring visits)

and report status to study team on a regular basis

. Prepare and update Inform Consent Forms and reviewed monitoring reports

. Review and approve CRO invoices and expense reports

. Coordinate database lock activities by working with DM and Stats to

reconcile date and queries for database lock

. Review and comment on SAP, IB, and lead recruitment efforts

. Managed risks associated to study timelines and data quality

Altana Pharma (acquired by Nycomed November 2006)

November 2006 - April 2007

Florham Park, NJ

Senior Clinical Trial Associate (Consultant) -- Phase I, III, and IV

Indication - GI, Allergy, Respiratory

Task & Responsibilities:

Managed operations of multiple clinical study programs including management

of CRO

Manages site selection & evaluation, investigator meetings, site start-ups,

and enrollments

Identify potential Investigators across all phases, collects and reviews

regulatory documents from clinical sites

Prepare and disseminate study related materials or tools (study manuals,

supplies, CRFs)

Communicate regularly with external AP staff, including regional CRAs

Participate in the development of IND Safety Alert letters

Assist in compilation of trial financial information along with the

development of clinical study budgets

Participate in budget and contract (CTA) negotiations with clinical site

personnel

Review data for safety and efficacy points, maintain database for both

internal and external research studies, primary efficacy variables,

laboratory data

Review data with statisticians on data review for Blind Data Review

Meetings

Supervise and provide mentoring to Clinical Trial Assistants

Assist in creating CRA training programs; work with CRA and clinical sites

to answer protocol related questions and concerns

Participate in monthly CRA/Investigator site conference calls to identify

study related issues and concerns

Reconcile trial master files during study closure

Serve as a point of escalation for unresolved issues

Transneuronix (acquired by Medtronic)

April 2004 - November 2006

Mt Arlington, NJ

Clinical Research Specialist Phase: II, III, and IV

Indication - Gastroenterology, Obesity, Diabetes

Task & Responsibilities:

Assist in managing all operational aspects of clinical studies to ensure

studies are completed on time, within budget and in compliance with SOPs,

FDA regulations and ICH/GCP guidelines

Assist on multiple study projects including domestic and international

studies

Complete co-monitoring visits and device implantation surgical monitoring

visits

Review site monitoring to ensure sites are compliant with regulatory

issues, protocol requirements and Good Clinical Practices

Ensure study timelines for enrollment, CRF completion and query resolution

are adhered to

Complete regulatory file review for study start up and study closure

Lead weekly monitoring meetings and report status of clinical projects to

study team on a regular basis

Review lab, ECG results of patients in clinical studies

Approve invoices for investigator payments based on CTA

Participate in review and design of CRFs and CRF completion guidelines for

assigned studies

Provide inputs for CRF revision, technical requirements for database

development and data quality

Assist in processing and coding AE/SAE in drug management, composing

protocol deviations, review Adverse Events, Concomitant Medication, Medical

History glossaries to ensure AE and SAE are correct

Assist in AE and SAE mapping from domestic and international study sites

Completion of data audits, and participate in edit check specifications

Work with statisticians and database programs in effort to ensure data

capture is accurate and complete for clinical close out reports and

database lock

Train staff and CRAs on proper CRF completion, source document review,

reviewing data, data querying and resolution

Contribute to the development of study specific procedure manuals and SOPs

Daughters of Israel January

2000-January 2002

West Orange NJ

Certified Nurse's Assistant

Task & Responsibilities:

. Assisting Nurses in providing primary health care to patients

. Assisting in drug administration and standard of care for patients

. Assisting patients with activities of daily living

Morristown Memorial Hospital

January 2000-

January 2001

Morristown NJ

Emergency Medicine Internship

Task & Responsibilities:

. Data entry and record retention of data for emergency medicine research

Education

Bachelors 2002

Major: Neurology and Biology

Drew University, Madison New Jersey

Certification of Completion 2002

Premedical enrichment program

Ohio University College of Osteopathic Medicine, Athens Ohio

Post Baccalaureate 2004

Advance sciences immunology biochemistry, pre-clinical drug research, 2004

University of Pennsylvania, Philadelphia PA

PROFESSIONAL ASSOCIATIONS AND DEVELOPMENT

. Member of American Academy of Allergy, Asthma & Immunology

. 26 PDU credits completed towards PMP Certification

. Clinical trial management, CTMS

. Clinical Data Application (including Oracle Clinical, InForm and OC-RDC)

. Microsoft Office (including Word, Excel, PowerPoint, Microsoft project)

. US CFR, EU, ICH and GCP guidelines

Contact this candidate