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sr project manager operations resume example with 16+ years of experience

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Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000, resumesample@example.com
Professional Summary
10 years of clinical research experience in a managerial position. Strong leadership and a team leader in managing clinical trials from phase I - phase IV. Responsible for the successful execution of all assigned projects that includes on-time, on-budget, and high quality/compliant results that leads to satisfied client. Execute as an integral part of the selling team through involvement in budgetary planning, initial development to completion of project, goals setting, recruiting monitoring, implementation of the protocol/research concepts, business development and management, design structure mapping and metrics, organizational layouts, clinical procedures and training and delegation of clinical/coordinating staff. Oversees the selection and identification of principal investigator. Oversees all clinical data management, TMF including IRB submission and correspondence, SAE reporting, and sponsor correspondence. Acts as an integral part of resolving protocol and internal staff issues. Oversee all clinical trials and sites in accordance with company SOPs, International Conference on Harmonization (ICH) WHO Good Clinical Practice (GCPs) standards and Federal Drug administration (FDA) guidelines. Responsible as a primary liaison between the Company and the Sponsor to ensure pre-study feasibility, initial start-up, on-going protocol monitoring and closeout according to the Sponsor's and the Company's contractual agreement. Oversees the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. Serves as the team leader by overseeing the project team, including the clinical/coordinating staff. Acts as a liaison and facilitator between other operation departments within the Company for project related tasks and/or issues. Plans and projects resources required across all areas of the study. Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. Oversees and tracks site payment issues as required. Performs ongoing review of project financial status of studies within his/her responsibility. Alerts senior management to potential issues and ensures necessary corrective action is taken. Independently prepares information for internal review meetings. Presents prepared information at project review meetings. Oversees the regulatory document collection and submission process. Ensures project documentation, including Trial Master Files (TMFs), are complete and audit ready. Act as an integral part in the negotiation and contracting process with outside customers. Oversees and evaluates project progress by maintaining timelines and other tracking/analysis tools. Oversees the tracking reports, and functional area plans to report to senior management. Maintains effective communication with the Sponsor and project team through oral and written correspondence, project status reports, and monthly progress reports, and presentations. Attends clinical monitoring staff meetings, project team meetings, and clinical training sessions according to the project communication, project management, and monitoring and/or training plans. Represent company at professional meetings or seminars including investigator meetings. THERAPEUTIC INVOLVEMENT Cardiology, Dermatology, Endocrinology, Infectious Disease, Pulmonary Disease, Urologic Disease, Rheumatic Disease, Pain Management, ENT, Psychological Disorder STRENGTH * Implementation of the protocol/research concepts, business development and planning, design structure mapping and metrics, organizational layouts and procedures. * Strong background in regulatory, TMF, IRB submission, drug development process. * Proficiency with Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines. * Versatility and ability to work independently. * Critical thinking / problem solving * Ability to handle multiple tasks and projects to meet deadlines while delivering high quality work. * Strong organizational and management skills as well as team-oriented approach.
Licenses
Pain Management Gastroenterology CCRA EDUCATION, TRAINING AND CERTIFICATES
Skill Highlights
  • Guest services
  • Inventory control procedures
  • Merchandising expertise
  • Loss prevention
  • Cash register operations
  • Product promotions
Professional Experience
01/2014 to Current SR. PROJECT MANAGER / OPERATIONS G3 CLINICAL TRIAL HOUSTON | City, STATE, RESPONSIBILITIES - Project Management / Business Development * Acts as a primary liaison between the Company and the Sponsor to ensure pre-study launch, initial start-up, on-going protocol monitoring and closeout according to the Sponsor's and the Company's contractual agreement. * Work with directors to propose and implement business development and process, and strategic improvement including maintaining effective contract management, and reviewing legal policies. * Oversees the study is progressing according to internal and Client quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. * Serves as the team leader by overseeing the project team. Plans and projects resources required across all areas of the study. * Oversees the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. * Strategic planning and management, projection of financial business performa and business plan including investor's offering documentation. * Monitor and identify site facility and interviewing principal investigator.
04/2013 to 12/2013 SR. CONSULTANT / CONTRACT E.N.T. - JAY CHAVDA, MD | City, STATE, Responsibilities - Project Management * Manages A Phase II, Multicenter, Double-Blind, Randomized dose and Duration Raging Trial Comparing Faropenem Daloxate at 600 MG and 300 MG Orally B.I.D. For 7 Days and 600 MG Orally B.I.D. For 5 Days in Subjects with Acute Maxillary Sinusitis Diagnosed by Antral Tap * Prospective, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 Days Versus Placebo Versus Telithromycin in the Treatment of Acute Exacerbation of Chronic Bronchitis * Acts as a primary liaison between the Company and the Sponsor to ensure pre-study launch, initial start-up, on-going protocol monitoring and closeout according to the Sponsor's and the Company's contractual agreement
06/2012 to 03/2013 SR. CONSULTANT / CONTRACT CLINICAL TRIAL NETWORK | City, STATE, Responsibilities - Lead study Coordinator * Manages multiple projects * Plans and projects resources required across all areas of the study. * Develops and maintains project plans for the study in accordance with SOPs and Work Instructions (WI). * Alerts senior management to potential issues and ensures necessary corrective action is taken * Ensure quality completion of call reports, follow-up letters, maintenance of study-related databases (overall patient status, site supplies, site contacts * Reviewing case report forms and against the subject's medical records for completeness and accuracy. Perform drug accountability. * Preparation/submission/QC of essential documents for study start-up/kick start and ongoing maintenance, including FDA form 1572, FDF forms, investigator brochures, consent forms, sponsor specific checklists, and CDAs. * Data management duties-Review specs of both paper and eCRFs. Maintenance and reconciliation of eTMF and TMF. * Maintain drug accountability
01/2010 to 09/2011 PROJECT MANAGER / OPERATIONS ALLEGIANT CLINICAL RESEARCH | City, STATE, RESPONSIBILITIES - Therapeutic Areas - Dermatology, Endocrinology, Pulmonary Disease, Urologic Disease, Gastroenterology, Psychological Disorder Managed multiple sites / Multiple projects * Acts as a primary liaison between the Company and the Sponsor to ensure pre-study launch, initial start-up, on-going protocol monitoring and closeout according to the Sponsor's and the Company's contractual agreement. * Oversees the study is progressing according to internal and Client quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. Serves as the team leader by overseeing the project team. * Plans and projects resources required across all areas of the study. * Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. * Monitor and identify site facility and interviewing principal investigator. * Creative problem solving and creative thinking * Oversees and evaluates project progress, timelines and other tracking/analysis tools. Produces and distributes status, resourcing, and tracking reports, and functional area plans to appropriate team members and senior management. * Maintains effective communication with the Sponsor and project team through oral and written correspondence, project status reports, and monthly progress reports, and presentations. * Attends clinical monitoring staff meetings, project team meetings, and clinical training sessions according to the project communication, project management, and monitoring and/or training plans and investigator meetings.
01/2006 to 01/2008 PROJECT DIRECTOR / COORDINATOR - SPECIAL PROJECT MERCURY PHARMA SERVICES | City, STATE, RESPONSIBILITIES - Therapeutic Areas - Cardiovascular, Dermatology, Endocrinology, Infectious Disease, Pulmonary Disease, Urologic Disease, Rheumatic Disease and Infectious Disease Manages multiple sites / Multiple projects * Acts as a primary liaison between the Company and the Sponsor to ensure pre-study launch, initial start-up, on-going protocol monitoring and closeout according to the Sponsor's and the Company's contractual agreement. * Ensures the study is progressing according to internal and Client quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. * Serves as the team leader by overseeing the project team. * Plans and projects resources required across all areas of the study. * Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. * Monitor and identify site facility and interviewing principal investigator. * Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. * Produces and distributes status, resourcing, and tracking reports, and functional area plans to appropriate team members and senior management. * Demonstrates working knowledge of current clinical environment and develops knowledge of drug development trends. * Facilitates team training in accordance with protocol and/or project requirements including therapeutic area, protocol specific, and process training. * Maintains effective communication with the Sponsor and project team through oral and written correspondence, project status reports, and monthly progress reports, and presentations. * Oversees all clinical data management, TMF including IRB submission and correspondence, SAE reporting, and sponsor correspondence. * Acts as an integral part of resolving protocol and internal staff issues. * Develops strong relationships with clients to generate new and/or add-on business for the future. * Provide insightful input on project-related documents and procedures, essential document, Case Report Forms, Data Management Plans, and Monitoring Plan. * Attends clinical monitoring staff meetings, project team meetings, and clinical training sessions according to the project communication, project management, monitoring and/or training plans and investigator meetings. * Assist as back-up coordinator - Reviewing case report forms and against the subject's medical records for completeness and accuracy. * Perform drug accountability. * Preparation/submission/QC of essential documents for study start-up/kick start and ongoing maintenance, including FDA form 1572, FDF forms, investigator brochures, consent forms, sponsor specific checklists, and CDAs. * Data management duties-Review specs of both paper and eCRFs. Maintenance and reconciliation of eTMF and TMF. RESPONSIBILITIES - Therapeutic Area - Infectious Disease Hospital Setting P.I.: Leo Mercer, MD - VP, URHCS * Acts as a primary liaison between the Hospital and the Sponsor to ensure pre-study launch, initial start-up, on-going protocol monitoring and closeout according to the Sponsor's and the Company's contractual agreement. * Responsible for the successful execution of all assigned projects that includes on-time, on-budget, and high quality/compliant results that leads to satisfied client. * Execute as an integral part of the selling team through involvement in budgetary planning, initial development to completion of project, goals setting, recruiting monitoring, implementation of the protocol/research concepts, policies, design structure mapping and organizational layouts. * Serves as the team leader by overseeing the project team and departments. * Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. * Acts as a liaison and facilitator between other departments within the hospital to ensure project related tasks and/or issues are addressed. * Remotely manage daily site activity such as inpatient/outpatient tracking, product training, study enrollment, study metrics tracking and reporting, clinical data flow according to URHS Standard Operating Procedures (SOPs). * Ensure quality completion of call reports, follow-up letters, maintenance of study-related databases (overall patient status, site supplies, site contacts * Reviewing case report forms and against the subject's medical records for completeness and accuracy. Perform drug accountability. * Preparation/submission/QC of essential documents for study start-up/kick start and ongoing maintenance, including FDA form 1572, FDF forms, investigator brochures, consent forms, sponsor specific checklists, and CDAs. * Data management duties-Review specs of both paper and eCRFs. Maintenance and reconciliation of eTMF and TMF.
Education and Training
Expected in to to B.S. | Clinical Trial Management University of Houston, , GPA:
EDUCATION, TRAINING AND CERTIFICATES University of Houston - Healthcare Administration/Management - B.S. - (in-progress) Association of Clinical Research Professionals - ACRP CCRA - (preparing for Fall 2015 examination) PROFIICIENCY - MSFT Software- Excel, Access, PowerPoint, Word and MSFT Visio, SharePoint and WebEx. CTMS - Clinical Trial Management, Electronic Data Capture, Medidata and RTSM and IVRS/IWRS.
Community Service
Languages
English and Malay
Presentations
Strong leadership and a team leader in managing clinical trials from phase I - phase IV. Responsible for the successful execution of all assigned projects that includes on-time, on-budget, and high quality/compliant results that leads to satisfied client. Execute as an integral part of the selling team through involvement in budgetary planning, initial development to completion of project, goals setting, recruiting monitoring, implementation of the protocol/research concepts, business development and management, design structure mapping and metrics, organizational layouts, clinical procedures and training and delegation of clinical/coordinating staff. Oversees the selection and identification of principal investigator. Oversees all clinical data management, TMF including IRB submission and correspondence, SAE reporting, and sponsor correspondence. Acts as an integral part of resolving protocol and internal staff issues. Oversee all clinical trials and sites in accordance with company SOPs, International Conference on Harmonization (ICH) WHO Good Clinical Practice (GCPs) standards and Federal Drug administration (FDA) guidelines. Responsible as a primary liaison between the Company and the Sponsor to ensure pre-study feasibility, initial start-up, on-going protocol monitoring and closeout according to the Sponsor's and the Company's contractual agreement. Oversees the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. Serves as the team leader by overseeing the project team, including the clinical/coordinating staff. Acts as a liaison and facilitator between other operation departments within the Company for project related tasks and/or issues. Plans and projects resources required across all areas of the study. Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. Oversees and tracks site payment issues as required. Performs ongoing review of project financial status of studies within his/her responsibility. Alerts senior management to potential issues and ensures necessary corrective action is taken. Independently prepares information for internal review meetings. Presents prepared information at project review meetings. Oversees the regulatory document collection and submission process. Ensures project documentation, including Trial Master Files (TMFs), are complete and audit ready. Act as an integral part in the negotiation and contracting process with outside customers. Oversees and evaluates project progress by maintaining timelines and other tracking/analysis tools. Oversees the tracking reports, and functional area plans to report to senior management. Maintains effective communication with the Sponsor and project team through oral and written correspondence, project status reports, and monthly progress reports, and presentations
Skills
Budgets, Liaison, Sops, Training, Project Management, Therapeutic, Ich, Interviewing, Project Manager, Case Report, Case Report Forms, Data Management, Fda, Maintenance, Medical Records, Reconciliation, Infectious Disease, Progress, Clinical Monitoring, Correspondence, Endocrinology, Cardiovascular, Clients, Clinical Data Management, Drug Development, Sae Reporting, Operations, Databases, Budget, Leads, Mapping, Metrics, Outpatient, Recruiting, The Selling, Topo, Gastroenterology, Problem Solving, Clinical Trial, Business Development, Business Plan, Contract Management, Documentation, G3, Strategic Planning, Corrective Action, Project Plans, Audit, Cardiology, Clinical Trials, Collection, Feasibility, Managerial, Pain Management, Phase Iv, Project Documentation, Access, Clinical Research, Excel, Healthcare, Microsoft Sharepoint, Powerpoint, Sharepoint, Trial Management, Visio, Word

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Resume Overview

School Attended

  • University of Houston

Job Titles Held:

  • SR. PROJECT MANAGER / OPERATIONS
  • SR. CONSULTANT / CONTRACT
  • SR. CONSULTANT / CONTRACT
  • PROJECT MANAGER / OPERATIONS
  • PROJECT DIRECTOR / COORDINATOR - SPECIAL PROJECT

Degrees

  • B.S.

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