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Clinical Trial Workflow Lead Resume Example

Resume Score: 80%

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CLINICAL TRIAL WORKFLOW LEAD
Professional Summary

Enthusiastic drug safety professional eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Motivated to learn, grow and excel in pharmacovigilance. In depth knowledge and understanding of global, regional, and local clinical research regulatory requirements as well as knowledge of applicable Safety Databases and other internal/Client applications. Excellent reputation for resolving problems and improving customer satisfaction with experience in clinical trial and post-marketing studies.

Skills

· Excellent organizational and time management skills with attention to detail.

· Proven ability to work independently and autonomously with policies and practices.

· Proven ability to multi-task, meet strict deadlines, manage competing priorities.

· Willingness and aptitude to learn new skills across Safety service lines.

· Ability to identify, prioritize tasks and delegate to team members.

· Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams' priorities.

· Excellent working knowledge of Microsoft Office, Excel, and Powerpoint.

· Safety Database Argus 8.1.2, clinical database InForm 6.1 and Rave

Work History
Clinical Trial Workflow Lead | 02/2020 to Current
IQVIA - Durham, NC
  • Support start-up of new projects using standard operating procedures and best practices, including identifying potential risks during project initiation and implementing mitigation measures to ensure seamless delivery at maintenance stage.
  • Manage customer interface and communication for assigned projects. Represent Lifecycle Safety on projects and serve as primary point of contact within Lifecycle Safety for all internal and external customers; liaise between internal/external customers and Lifecycle Safety Operational teams.
  • Manage customer deliverables for assigned projects and bring continuity to project design and delivery through customer delivery. Tactical, day-to-day customer-facing leadership at project level. Responsibilities include project planning (timelines, deliverables), defining project/scope management, quality management and project financial management.
  • Attend meetings with internal and external stakeholders. Provides project status updates, defines processes, project planning/strategy.
  • Contributes during client and internal audits and inspections for assigned projects. Liaise with Quality Assurance staff and management in the compilation of Corrective Action Plans.
  • Work closely with Lifecycle Safety management to address problem areas and customer needs.
Senior Safety Operations Specialist | 05/2017 to 02/2020
IQVIA - Durham, NC

· Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.

· Perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events (AE)/endpoint information, and determining initial/update status of incoming events

· Database entry coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, and coordinating translations, as per internal/ project timelines.

· Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting.

· Liaise with manager for regulatory tracking requirements and electronic reporting.

· Ensure to meet quality, productivity and delivery standards per project requirements.

· Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.

· Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work for assigned projects

· Set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement.

· Effective feedback on project performance to junior members of team.

· Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes.

· Liaise with client in relation to details on day to day activities as needed.

Senior Consultant Nurse | 10/2011 to 05/2017
PPD - Morrisville, NC

· Responds accurately and professionally to technical and medical information inquiries received via phone, email, internet or mail in reference to pharmaceutical or device products. Processes fulfillments and provides clinical trial information or after-hours on call support.

· Analyzes caller's questions to formulate an accurate and concise response using client-approved resources and records inquiries and interactions in the appropriate databases following organizational, client and regulatory guidelines.

· Identifies, records and triages adverse events and product complaints according to organizational, client and regulatory guidelines and provides additional support (including follow up) as needed.

· Maintains thorough knowledge of project and corporate policies and procedures including client products, SOP's, protocols, GCP's, and applicable regulatory requirements.

· Works closely with internal and external client contacts (up to and including members of client management) to resolve complex inquiries. As needed, researches medical literature and drafts responses for such inquiries.

Education
Montgomery Community College - Takoma Park, MD | Associate of ScienceNursing, 05/2003
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Resume Overview

Companies Worked For:

  • IQVIA
  • PPD

School Attended

  • Montgomery Community College

Job Titles Held:

  • Clinical Trial Workflow Lead
  • Senior Safety Operations Specialist
  • Senior Consultant Nurse

Degrees

  • Montgomery Community College - Takoma Park, MD | Associate of Science

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