Study Start-up Specialist (RSU) - LISBON (R1110339) in Oeiras, Portugal at IQVIA™

Date Posted: 2/12/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    2/12/2020
  • Job ID:
    R1110339

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

PURPOSE

Manage and perform tasks at country level associated with Regulatory, Start-Up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual guideliness.

RESPONSIBILITIES

  • Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Feasibility, Site Identification and Project Leadership.
  • Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
  • Review, prepare and negotiate site contracts and budgets with sites.
  • Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics ICF and IP Release documents, in line with project timelines.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Distribute completed documents to sites and internal project team member
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
  • Where applicable, act as a Country Lead for projects and assist in pre-award activities including bid defenses, proposals and oversights of the scope of work at country level.
  • May act as Local Regulatory, Ethics and Contract Expert and reviewer of ICF.
  • May act as mentor, and prepare and deliver country-specific training, for less experienced staff.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Effective communication, organizational and planning skills
  • Ability to work independently and to effectively prioritize tasks
  • Ability to work on multiple projects
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Good command of English.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s Degree in life science or a combination of education and experience.
  • Minimum of 2 years of regulatory start-up/submission experience

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.



Job ID: R1110339