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Cpc Clinical Research - Associate Director Resume Example

Orn Mmlacliwis
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Aurora, CO 80016
80016, Aurora CO
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Professional Summary

Experienced pharmacovigilance professional with more than 14 years of experience in clinical research. Excellent pharmacovigilance, protocol development, and Clinical Study Report development skills. Track record of providing clients with a wide range of on-time, quality deliverables.

Skills

Clinical Study ReportsClinical trial pharmacovigilance

Protocol developmentProject management

Data analysis and reportingSupervisor

Experience
Associate Director Jun 2013Current CPC Clinical Research Aurora, CO
  • Scientific and Medical Affairs (SMA).
  • Provide management of pharmacovigilance activities including, but not limited to, safety signal detection, serious adverse event intake and assessment, narrative writing, site follow-up and regulatory report generation (MedWatch, CIOMS, etc.).
  • Lead development of study protocol synopses, protocols, and protocol amendments.
  • Lead development of Clinical Study Reports from planning, writing and publishing.
  • Lead development of Safety Plans.
  • Lead development and revision of standard operating procedures, policies and work instructions originated in the Scientific and Medical Affairs department and/or pertaining to Scientific and Medical Affairs integration into CPC Clinical Research activities.
  • Led implementation of ArisGlobal safety database.
  • Provide expert review of procedure/operations manuals, case report forms, Data Management Plans, and Statistical Analysis Plans.
  • Assist the Director of Scientific and Medical Affairs in the coordination and integration of activities by members of the department as well as the management of timelines for activities and deliverables of members of the department.
  • Assess project and Scientific and Medical Affairs department concerns and challenges, and propose solutions to the project team, Director of Scientific and Medical Affairs, Director of Clinical Research and President, as appropriate.
  • Assist the Director of Scientific and Medical Affairs and Director of Quality and Compliance department in quality assurance efforts.
  • Assist in the operational management of Data Monitoring Committees, as needed.
  • Participate as an active member of project teams for clinical studies, including providing updates to the study project manager as requested.
  • Provide site staff training on pharmacovigilance activities at Investigator Meetings.
  • Represent CPC Clinical Research in conversations with prospective clients and provide guidance as it relates to Business Development efforts.
  • Lead the development of federally funded grant submission materials.
  • Address questions regarding scientific and related procedural issues from Investigators and project managers, and interact with sites as appropriate to facilitate trial conduct or enrollment.
  • Report regularly on program/project progress to the Director of Scientific and Medical Affairs and the Director of Clinical Research, and to the CPC Executive Committee as requested.
Manager Jul 2008Jun 2013 CPC Clinical Research Aurora, CO
  • Served as direct supervisor to regionally-based and in-house Clinical Research Associates.
  • Responsibilities included, but are not limited to staff evaluations, goal creation and tracking, and training.
  • Led Clinical Research Associate candidate identification and pre-screening.
  • Served as Project Manager on Phase 2 and 3 studies.
  • Responsibilities included, but were not limited to management of study start-up activities, enrollment and follow-up phases, and study close out.
  • Assisted with the development of study protocols, budgets and proposals, contracts, change orders, and study content documents including case report forms, statistical analysis plans, study reports and monitoring documents.
  • Developed a unique study endpoint that allowed Sponsor to implement study at a fraction of the cost and at any study site, including the procurement of new technology for data collection.
  • Assessed project issues, proposed resolutions to the project team, CPC Clinical Research executives and/or the Sponsor, and then tracked implementation and resolution through to completion.
  • Provided status reports to the Director of Research Operations on all projects as necessary.
  • Provided necessary updates and reports to the Sponsor as outlined by the contract.
  • Ensured the overall quality of project services and deliverables.
  • Assisted the department in the procurement of new technologies utilized for the purpose of study endpoint assessments.
  • Developed and implemented processes that improve department activities and create efficiencies.
  • Managed and conducted CPC Clinical Research Core Lab activities.
Assistant Project Manager May 2007Jul 2008 Colorado Prevention Center Denver, CO
  • Assisted lead Project Manager in monitoring project timelines and deliverables.
  • Helped assess project issues and propose resolutions to the lead Project Manager.
  • Participated in the design, writing and review of all project-related documents including: protocols, case report forms, source documents, monitoring plans and study operation manuals.
  • Provided status updates to the lead Project Manager on projects as necessary.
  • Participated in both onsite and offsite Sponsor training sessions.
  • Monitored study sites as required.
Clinical Research Associate Jun 2005May 2007 Colorado Prevention Center Denver, CO
  • Monitored clinical trials under the guidance of GCP and FDA regulations.
  • Performed site evaluation and initiation visits.
  • Developed study related materials, including source documents.
  • Developed training materials and presentations for investigator meetings, including presentation of material.
  • Maintained required records for monitoring activities, expenses and travel.
  • Generated monitoring visit reports and follow-up letters documenting visit findings.
  • Prepared audit responses for audits conducted domestically and internationally.
  • Spearheaded the creation of serious adverse event reporting documents, Safety Plan and related documents for an international peripheral artery disease study.
  • .
Drug Safety Specialist Oct 2004May 2005 Valeant Pharmaceuticals, Inc Costa Mesa, CA
  • Performed safety review of all serious adverse events originating from Valeant Pharmaceutical's three global trials involving over 2000 subjects.
  • Generated multiple safety related reports including FDA and European annual reports and quarterly Data Monitoring Committee reports.
  • Prepared expedited safety reports for distribution to over 19 regulatory agencies.
  • Composed safety related study case report forms and accompanying guidelines.
  • Trained all new department employees including Drug Safety Specialist, Quality Control Specialist and Database Administrator.
Drug Safety Administrator Apr 2004Oct 2004 Valeant Pharmaceuticals, Inc Costa Mesa, CA
  • Performed case triage and data entry for all serious adverse events originating from Valeant Pharmaceutical's clinical trials.
  • Led department in validation of safety database.
  • Performed quality assurance checks for all case reports, interdepartmental team meetings, including investigator meetings.
  • Prepared departmental operating budgets as well as managed departmental contracts and invoices.
Customer Service Representative Jun 2003Apr 2004 Valeant Pharmaceuticals, Inc Costa Mesa, CA
  • Managed "house" accounts that represented Valeant Pharmaceutical's largest direct-to-physician accounts, yielding more than $1.8MM in 2003 sales.
  • Trained as an Import Compliance Officer for North America pharmaceutical division.
  • Generated daily sales reports for North America pharmaceutical division.
  • Acted as department point person for all wholesale purchase orders.
Health Unit Coordinator Apr 2002Apr 2003 Saint Anthony North Hospital Westminster, CO
  • Acted as liaison between emergency room and all other departments within hospital and Centura Health System.
  • Utilized operational knowledge of all hospitals and departments within the Centura Health System for purposes of admittance, patient transfers and patient confidentiality.
  • Audited patient charts to ensure accurate patient billing.
  • Resolved patient complaint issues with assistance of Patient Services Representative.
Education
CITI Health Information Privacy and Security Training Jan 2016
CITI Group 1 Biomedical Investigators Training Jan 2016
ARISg 7.1.1 Administrator Training Jan 2016
Jan 2015 ARISg 7.1.1, Alerts and CCM Training, Coding with Masters MedDRA and WHO-DD Training
Jan 2011 Sponsor Management of Investigator Non-Compliance
Jan 2010 Promoting Excellence in Clinical Research: GCP for Monitoring and Project Management
Jan 2008 clinicaltrials.gov-Your Guide to Filing and Complying, Project Management Fundamentals
Jan 2007 InForm 4.5 ITM for CRAs
Medical Writing, Protocol Development and Clinical Study Reports Jan 2006
Applied Good Clinical Practices Jan 2006
Oracle AERS 4.3 - End-user Training Jan 2004
Monitoring and Reporting Adverse Drug Reactions Jan 2004
CITI Good Clinical Practice and ICH Longmont, CO Front Range Community College Jan 2002
B.S: Biological Sciences, Human Anatomy and Neurobiology Fort Collins, CO Colorado State University Jan 1999
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Resume Details

This is a real resume for a Associate Director in Aurora, Colorado with experience working for such companies as Cpc Clinical Research, Colorado Prevention Center, Valeant Pharmaceuticals Inc. This is one of the hundreds of Associate Director resumes available on our site for free. Use these resumes as templates to get help creating the best Associate Director resume.

Previous Companies:

  • CPC Clinical Research
  • Colorado Prevention Center
  • Valeant Pharmaceuticals Inc

Previous Job Positions:

  • Associate Director
  • Manager
  • Assistant Project Manager
  • Clinical Research Associate
  • Customer Service Representative

Schools:

  • Front Range Community College
  • Colorado State University

Level of Education:

  • CITI Health Information Privacy and Security Training
  • CITI Group 1 Biomedical Investigators Training
  • ARISg 7.1.1 Administrator Training
  • Medical Writing, Protocol Development and Clinical Study Reports
  • Applied Good Clinical Practices
  • Oracle AERS 4.3 - End-user Training
  • Monitoring and Reporting Adverse Drug Reactions
  • CITI Good Clinical Practice and ICH
  • B.S

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