Title:Malaarni Gloria

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Name: Malaarni Gloria

Address:

City: Chula Vista

State: CA

Zip/Postal Code: 91913

Country:

E-mail: abpe8s@r.postjobfree.com

Primary Phone:

Background

Most Recent Job Title: Clinical Project Manager

Most Recent Employer: Gen-Probe, Inc.

Career Level: Manager, Director Level

Availability or Timeframe: Immediately

Authorized to work in the US: Yes

Security Clearance:

Do you have transportation: Yes

Over 18: Yes

Education: Bachelors

Languages Spoken: English

Job Preferences

Desired Salary: Open

Willing to Relocate:

Desired Job Titles: Clinical Trials Manager

Sr. Clinical Research Associate

Desired Job Types: Employee

Work Status: Full Time

Desired Shifts:

Desired Travel: 25%

Category: Other, Project Management

Company Size:

Company Type:

Industry: Biotechnology, Pharmaceuticals

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Copyright c 1997- Lee Hecht Harrison, Inc.

Malaarni B. Gloria

Chula Vista, California abpe8s@r.postjobfree.com

Cell: 619-***-****

OBJECTIVE: Seeking a position as a Clinical Study Manager.

QUALIFICATIONS:

Over 13 years of Clinical Research Experience: 6+ years monitoring and 7+ years in

Project Management.

Managed and supervised a total of 10 CRAs and Lead Clinical Manager for International

Trial.

Responsible for providing Annual Appraisals/Evaluations on the CRAs and Administrative

Support.

Directly Negotiated the Clinical Agreements and Budget with Study Centers and Outside

Vendors.

Primary sponsor contact for Central IRBs

Developed and maintained tracking tools (Enrollment, Site Start-up/IRB Status, Regulatory

Document Collection, Site Payments, Vendor Payments, Status of Clinical Agreements, etc)

Created Monitoring Manual/CRA Tools, Site Reference Manual, Pharmacy Manual, Lab

Reference Manual, and Logs/Tracking Tools.

Provide presentations and high level updates to Sr. Management Team.

Develop a site payment schedule (quarterly, milestone, and task oriented/visit based).

Excellent Time Management and Organizational Skills.

Direct point of contact with Sites, CRAs, Vendors (including CROs).

Assist with preparation of IND Submissions, Annual Review Updates to the FDA.

Facilitator for Clinical Research Dept Training and SOP Training.

Effectively work with other internal departments to assure project success.

PHARMACEUTICALS / BIOTECH EMPLOYMENT HISTORY:

Gen-Probe, Incorporated

March 2009November 2009

Ligand Pharmaceuticals, Inc

. May 2006 to March 2009

Pacific Biotech

1992 to 1993NOTE

: From 1995 through April 2006 employed at Contract Research Organizations (CROs).

ACCOMPLISHMENTS

Received the Ligand 2008 Achievement of the Year award for meeting Phase IIA Proof of

Concept Study Timelines (Specifically Sites Open and Study Enrollment). This award was

given because both my Sr. Director and I saved the company approx. $ 1 million USD, as all

the work outsourced to the CRO was brought back internally and managed by both me and the

Sr. Director

.

The 2008 Achievement of the Year Award (Company wide) is given to the person(s) who go

over and beyond their expected roles/responsibilities, saving the company thousands or

millions of dollars.

Beat the anticipated odds that the Study Enrollment for the Ph-IIA study would not be met

by years end (2008).

Gen-Probe, Incorporated, San Diego, CA 20092009Sr. Clinical Project Manager

Organized and facilitated the clinical deliverable to completion according to the

established timeline and budget in compliance with GCP/ICH and human subject regulations.

Worked with Legal Dept and Clinical sites in solicitation & negotiation of clinical site

budgets & contracts.

Point of contact with CROs, Third Party Vendors, and Central IRB.

Facilitated the Weekly Project Management, Clinical Operations, and Study Data Review

Meetings.

Direct oversight of all study agreements with sites, CRO(s), and outside third party

vendors.

Facilitated identification & qualification in conjunction with Clinical Management

approval, the hiring of appropriate CROs and Study Suppliers.

Communicated status of clinical trial deliverables to clinical functional management and

core management team.

Established and assured adherence to budgets, schedules, work plans, and performance

requirements for project team.

Ligand Pharmaceuticals, Inc

., San Diego, CA 20062009Manager, Clinical Project Management

Assisted with writing and development specific sections of the study protocol.

Negotiated the Clinical Site Research Agreements, Budget, and Payment Schedule / Invoices

with Investigator Sites and Third Party Vendors.

Direct point person with third party vendors (Clinical Drug Distribution, Data

Management, Contract Research Organization, Contract CRA, etc.)

Assisted with Site Grant Payments, Invoice Payments, and other financial transactions

with outside vendors or sites.

Coordinated Monthly Investigator/Site Coordinator phone calls to discus pertinent study

related topics, issues, and training (protocol, study procedures, addressing DCF queries).

Led internal CORE Team Meetings with primary study team, data management group,

biostatistician(s), Program Director, and Head of Clinical (occasionally).

Primary Clinical Training Manager who scheduled on-site training/audio conference

training on Clinical Research specific issues (eCTD, GCPs, Clintrials.gov, overview on

conducting trials in various parts of the world.)

SOP Committee member responsible for updating, initiating, and implementing the Clinical

Department SOPs required to complete our Phase I and Phase II programs.

Direct contact with hired contract CRA. Manage and Review all project related study visit

reports and documents.

Direct point person with central IRB.

Responsible for providing sections of the IND Submissions to the FDA. Also participated

in the review process of the complete IND Submission.

Involved with providing specific sections of the Annual Study Report before it is sent to

the Regulatory Body.

- Organized and facilitated all study related documents collected by the CRA, and sent in

by the study sites.

- Provided high level summaries / updates on progress of study to Sr. Management Team.

(Enrollment, Contracts/Budget Status, IRB Status, Drug Shipment status, etc)

Omnicare Clinical Research, Inc

., San Diego, CA 2002 - 2006

Regional Sr. Clinical Trial Manager

(Home-based) 2005 - 2006

Regional Clinical Trial Manager

(San Diego, CA) 20022005

- Established and maintained positive client interactions/communications with sponsors

regarding clinical issues and project goals. Ensured the delivery of quality services to

the sponsor.

Coordinated investigator meetings. Prepare agenda and scheduled speakers

Actively participated in client and project team meetings/presentations during the course

of the clinical trial

Responsible for write-up of Annual Appraisals / Evaluations on CRAs and administrative

support.

Developed and wrote monitoring guidelines prior to study initiation, obtained sponsor s

approval, and conducted CRA training

Updated guidelines as needed throughout the conduct of the study

Effectively managed and provided support to CRAs in the conduct of the clinical trial by

reviewing monitoring reports

Reviewed and approved monitoring reports to ensure; issues are appropriately documented

and followed up on at subsequent visits

Arranged for or perform periodic quality control visits with the CRAs as specified in the

contract and/or as required by company standard operating procedures to ensure CRAs

observe Good Clinical Practice (GCPs)

Provided input for the annual performance reviews of CRA employees assigned to the

project

Arranged for therapeutic area training as needed to CRAs on project

Reviewed CRAs Planned Visits schedule, assuring frequency is per contract, and travel

between locations is well planned, taking action when problems are noted

Routinely managed the clinical trial budget by insuring visits and hours billed to the

project are in accordance with the contract.

Provided assistance in proposing appropriate investigators, reviewed and approved the

recruitment list prior to submission to the sponsor, assuming appropriate eligibility

checks have been done (e.g. debarment lists, consultation with local colleagues)

Tracked and approved investigator payments

Updated, distributed and ensured the accuracy of the investigator and CRA site

assignments list

Effectively worked with other internal departments to assure project success

Coordination, review and approval of critical document packages (including translations

where required).

Revenue recognition and forecasting tasks for assigned Clinical Operations and CTM

responsibilities

Participate in project Lessons Learned Session to assess success.

Traveled to Amsterdam and Berlin for Study Investigator Meetings and provide project /

study-related training to other study managers and CRAs (outside of US).

PPD Development, San Diego, CA, USA 2001 - 2002Project Manager

Directly performed the function of the Project Manager in all aspects of running the

project and managing personnel.

Managed a global / international trial involving Europe. Communicated with Client

regarding project issues.

Managed and supervised a total of 10 CRAs. Provided annual appraisals/evaluations on

performance of monitoring and site management of each of the direct reports.

Provided monitoring review and tracking of clinical data and preparation of study

specific documents according to FDA regulations, ICH Guidelines, and PPD procedures.

Oversees training of site personnel and project team as appropriate, including mentoring

of Sr. CRAs

Analyzed and oversaw cost, personnel hours and project needs to determine the most cost

effective and efficient means to successfully run and complete projects, while meeting the

Client s needs and adhering to the contract.

Provided direct supervision of all clinical and administrative aspects of clinical

program as well as oversaw other portions of the contract (i.e., Pharmacovigilance,

Medical Writing, Data management, Biostats)

Successfully completed a Phase IV, 6-month, In-patient Trial involving 15 U.S. and U.K.

study centers, within scheduled timeline and within study budget.

PPD Development, San Diego, CA USA 2000 - 2001Senior Clinical Research Associate

Assisted the Project Manager and contributed to the team with various activities

including allocation of project hours (PHAs), and budgets for various team members and

respective tasks; developed and reviewed case report forms, CRF guides and Master Actions

Plans (MAPs), identified and evaluated potential investigators; collected and reviewed

critical documents; attended and presented at investigator meetings; conducted, documented

and trained others on all types of monitoring visits; managed sites; documents and reports

serious adverse events; and reviewed data tables and listings.

Premier Research Worldwide, LTD

., Philadelphia, PA, USA 19992000Regional Clinical Research Associate

The following 3 trials were monitored simultaneously:

Phase III Atrial Fibrillation Investigational Drug Study for 11 Investigator Sites.

Performed pre-study, initiation, interim monitoring, and close-out visits.

Phase III Pediatric, Attention Deficit Hyperactivity Disorder study for 7 investigator

sites. Assisted with the proper ordering and return of controlled study drug. Average

enrollment 20 patients/site.

Breast Cancer Device Trial. Expected enrollment of 80 patients per site. Performed the

pre-study, initiation, and interim monitoring visits of the site. Trained the

investigators and staff on the usage of study device.

Quintiles CNS Therapeutics, San Diego, CA, USA 1998 - 1999Senior Clinical Trial Associate

Lead CRA on Phase III Double-Blinded Schizophrenia Trial. Assisted the project manager

with the daily operations of all clinical activities. Monitored clinical trials in

accordance with good clinical practices, sponsor SOP requirements, and FDA regulations.

Coordinated with the sponsor in the preparation for an investigator meeting. Supervised

and coordinated the functions of 5 CRAs in support of the project.

Quintiles CNS Therapeutics, San Diego, CA, USA 19951998Clinical Research Associate

Monitored the conduct of clinical drug trials for central nervous system drug studies.

Ensured adequacy of clinical research staff and facilities and global regulatory

requirements.

International Clinical Research Corporation

19951995

(ICRC

), San Diego, CA, USA

Clinical Assistant

Assisted CRAs, Project Managers, and other clinical operation staff in-house monitoring

activities. Assured adherence to good clinical practices at investigational sites.

Corresponded with potential investigators during site selection, and maintained contact

with site to ensure protocol adherence. Coordinated shipment of study-related materials.

Resolved specific site problems (i.e., drug storage or form completion). Maintained

telephone contact with site, CRA, and staff help-lines.

Pacific Biotech, Inc

., San Diego, CA, USA 1992 - 1993Microbiology Lab Specialist

Assigned to Microbiology Laboratory/Research and Development Department. Performed

routine assignments in support of product development, scale-up, process optimization,

technology transfer, process validation activities in production of streptococcus, and

pregnancy test kits. Performed tissue culture work, gram stain, pH balance, made media,

and was responsible for maintaining bacterial collection. Maintained MSDS and laboratory

notebook. Provided technical briefs and presentation to associates and scientist on

progress of assigned projects. Independently performed laboratory research work in

compliance with SOPs, GMP standards, Batch Record requirements, and Hazardous Material

Protocols. Devised and implemented bacterial collection and chemical supply computerized

database, which greatly enhanced the ordering of supplies, and reduced spoilage.

THERAPEUTIC EXPERIENCE

Therapeutic Categories Specialized Area(s) Phase(s) / Years of Experience Pulmonary /

Embolic (Imaging) Deep Vein Thrombosis Phase II / 2 years Blood Disorder Immune

Thrombocytopenic Purpura (ITP) Phase IIA / 1.5 years Device Occluded Catheter / In-patient

and Out-patient Phase III / 1 year Diagnostics Assay for Cervical Cancer Phase II/6 months

CNS Data Import Trial Phase II and III / 4 months Cardiovascular / Imaging Myocardial

Infarction Phase II / 1 year 2 months Cardiovascular / Imaging Myocardial Infarction Phase

II / 1 year 2 months Oncology Cervical Cancer

Lung Cancer / In-patient

CTCL (Cutaneous T-Cell Lymphoma) Phase II / 6 months

Phase II / 1 Year 2 months

Phase III / Data Endpoint Review Neurology ADHD (Pediatrics) PhaseIII / 1 Year Women s

Health / Oncology Breast Cancer Phase II / 1 Year Pharmacology Cardiovascular Drugs Phase

III / 1 Year CNS Schizophrenic Disorders Phase IIIB / 1 Year 6 months CNS Alzheimer s

Disease / In-patient and Out-patient Phase III / 2 Years 4 months CNS Alzheimer s Disease

Phase III/ 1 Year 8 months

EDUCATION

University of California,

San Diego, La Jolla, CA, USA

BA,

Sociology (December 1994)

COMPUTER SKILLS

MS Office (Word, Excel, MS Projects, PowerPoint, Visio, Oracle)

Access (Database)

REFERNCES

Available upon request.

Updated Date: 13 January 2010 Page of

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