Assoc PV Solutions Project Manager - (1803639) in Durham, NC at IQVIA™

Date Posted: 5/8/2018

Job Snapshot

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Description

PURPOSE
 
Lead large (over 500 adverse events (AEs)/endpoints) and/or multiple global clinical or post marketing projects ensuring all activities are completed on-time, within budget and meet quality standards. Obtain and process AE/ICSR/endpoint data obtained in clinical trials or post marketing projects according to applicable regulations and guidelines, standard operating
procedures (SOPs), and project requirements.
 
RESPONSIBILITIES
  • Establish and maintain a thorough understanding of project protocol, budget and scope of work (SOW) for assigned projects; set up and maintain project materials such as project files, forms, templates, databases and workflow.
  • Build a positive, collaborative team environment with project team members; provide training and mentoring for project team members and department staff; assist management with allocating resources to projects.
  • Establish and maintain effective project communications by representing department at interdepartmental project team meetings, investigator meetings, and client meetings and by conducting productive internal department project team meetings; provide global coordination of departmental activities.
  • Participate in client and internal audits for assigned projects. Liaise with Quality Assurance staff and overall management in the compilation of CAPs.
  • Track financial status of assigned projects; assist Project Manager with clinical related change orders. Attend and represent assigned projects at financial meetings.
  • Provide comprehensive feedback on project team members for input into appraisals. Provide consistent and frequent feedback to department managers on staff quality and progression.
  • Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns; participate in project review meetings with management; communicate and document project issues to project team members and department management in a timely manner; complete regulatory reports.
  • Drive case follow-up and closure processes; process cases as needed.
  • Assist senior leaders in managing department by identifying, developing and implementing new processes and systems designed to improve quality and efficiency, updating managers on new regulations, representing department at sales, marketing, bid defense and other extra-departmental meetings, creating and modifying SOPs and work instructions (WIs).
  • Obtain and process adverse event (AE)/ICSR/endpoint data obtained in clinical trials or post marketing projects according to applicable regulations and guidelines, standard operating procedures (SOPs), and project requirements.

Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • In-depth knowledge of event processing and Clinical Event Validation and Adjudication in both clinical and post marketing areas
  • In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • In-depth knowledge of departmental standard operating procedures (SOPs)
  • Skill in use of multiple safety databases
  • Strong project management skills
  • Strong coaching skills
  • Strong team building skills
  • Excellent written communication skills
  • Ability to lead projects within strict deadlines
  • Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities
  • Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representative
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • MINIMUM REQUIRED EDUCATION AND EXPERIENCE
    • Bachelor's degree in Pharmacy or Nursing or educational equivalent and 5 years relevant clinical experience including 3 years experience managing clinical or post marketing projects; or equivalent combination of education, training and experience
    PHYSICAL REQUIREMENTS
    • Extensive use of telephone and face-to-face communication requiring accurate perception of speech
    • Regular sitting for extended periods of time
    • Extensive use of keyboard requiring repetitive motion of finger 

    EEO Minorities/Females/Protected Veterans/Disabled


         

        We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.


        Whatever your career goals, we are here to ensure you get there!


        We invite you to join IQVIA™.


        Job ID: 1803639