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Data Management

Location:
San Jose, CA
Salary:
$110,000
Posted:
January 18, 2016

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Resume:

Marianne Balaura *

MARIANNE BALAURA

408-***-**** acs5sl@r.postjobfree.com www.linkedin.com/in/mbalaura Clinical Data Manager/Analyst

Highly experienced in analytical data analysis and data management including interpreting and documenting analytical stability data within pharmaceutical and medical device industries. Ability to multi-task and collaborate in multi-disciplinary environments to enhance and advance product portfolios.

Extensive pharmaceutical and stability expertise and knowledge in management of these programs. Efficient in execution of trend analysis of data, and authoring of protocols, reports and products stability/shelf life sections of regulatory submissions in alignment with all requirements. Knowledge in completion and design of Case Report Forms (CRF), through in class practical exercises.

KEY COMPETENCIES

● CMC / PMA ● cGMP / GLP / GCP ● Sharepoint

● FDA / ICH ● LIMS ● Data Mining

TECHNICAL SKILLS

● LIMS Application: SQL*LIMS ● Statistical Application: JMP

● Database Application: Cognos ● Word, Excel, Visio, Outlook, PowerPoint PROFESSIONAL EXPERIENCE

ABBOTT VASCULAR, SANTA CLARA, CA 2002 - 2015

Senior Stability Scientist (2006 – 2015)

Managed the accuracy and integrity of 10 stability programs for drug eluting stents (DES)/ bioresorbable scaffolds (BVS) from early phase, proof of concept, clinical, developmental, formal and commercial studies.

Assembled data and entered into the computerized database systems.

Solved operational and investigational problems in collaboration with colleagues.

Assisted statisticians in statistical analysis of data.

Increased the quality and reliability of critical data by eliminating the business risk of using a multi-step manual transcription process for stability data tables.

Reduced time to compile stability data for annual reports by 50% through data mining.

Accountable for the design, execution and compliance readiness of stability programs

Served as a subject matter expert (SME) for stability questions and LIMS

Provided technical support and performed critical and scientific data analysis, including statistical analysis for comparability and shelf life studies

Authored and reviewed over 50 stability protocols and wrote over 150 reports in accordance to regulatory guidelines to determine and confirm the product stability.

Authored over 15 stability sections of CMC for regulatory submissions.

Worked closely with other stability personnel and senior management to develop harmonized strategies, standards, business processes and tools, and resource planning.

Built key partnerships and collaborated with key leadership stakeholders in the other areas of the business including Analytical / Reliability testing laboratories, Quality, Regulatory, IT, Manufacturing, Supply Chain and Supplier Quality.

Managed and monitored milestones and detailed/dynamic timelines for various stages of Marianne Balaura 2

product development while providing timely and transparent communications to cross functional teams and management, to achieve all departmental and corporate goals

Assisted in expansion of the department from 3 to 16 staff members, created new procedures, conducted training, mentored and provided troubleshooting to colleagues.

Achieved 100% on-time pulling of samples for all study time points and coordinated all required testing.

Managed/mentored 3 technicians and over 10 scientists and other colleagues to execute sample management for all stability studies.

Facilitated 4 employees in the implementation of various software upgrades for LIMS.

Reduced off-site stability samples storage cost by 25% through efficient negotiation.

Provided technical leadership to the team in inspection/audit situations by thinking critically, acting creatively and providing information quickly and accurately.

Calculated and forecasted stability costs for sample storage and testing quantities.

Decreased the operational cost by $23K after decommissioned chambers based on cost/benefit analysis.

Awards:

Abbott Vascular “The Power of Performance” Awards (2006 - 2015)

Abbott Vascular R&D Excellence Award (2006)

Stability Quality Engineer, Combinational Device (2003 – 2006) Oversaw the design, implementation and execution of over 15 stability studies. Provided technical leadership for the research, developmental, clinical, formal, and marketed programs.

Interpreted critical results to answer scientific questions.

Identified and investigated aberrant test results and adverse trends.

Presented stability results in multi-functional technical reviews.

Wrote, designed and modified new procedures, processes and forms.

Trained and mentored over 10 users and provided troubleshooting for SQL*LIMS. Award:

Abbott Vascular People Choice Award (2005)

Bioanalytical Chemist (2002 – 2003)

Responsible for bioanalytical support to preclinical R&D products.

Analyzed artery tissue samples using LC-MS and presented results to preclinical team. Analytical Chemist (2002 – 2002)

Responsible for analytical support of R&D products.

Performed various analytical tests: drug content, impurity, release rate, and cleaning assessment assays using HPLC, release rate tester and other analytical instruments.

Reviewed analytical data packages per SOPs and cGMP guidelines. EDUCATION

Continuing Education Program: Clinical Trials, UCSC Silicon Valley Extension, Santa Clara, California course work (GCP, Clinical Trial Site Monitoring, Drug Safety and Adverse Events Reporting)

Post-Graduate Diploma, Pharmaceutical QA & QC, Toronto Institute of Pharmaceutical Technology (TIPT), Toronto, Ont., Canada

Bachelor of Science Degree, Human Biology, University of Toronto, Toronto, Ont., Canada



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