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Associate Director, Study Start-Up (Home-Based, Europe) - IQVIA Biotech

IQVIA Holdings Inc.

Various Locations

IQVIA Biotech is now hiring for a Associate Director, Study Start-Up.

BASIC FUNCTIONS:

The Associate Director of SSU is responsible for the management, training and development of the Local Start-Up Specialists (LSUS) and Managers, SSU. Assist with the development and implementation of department procedures and directs overall team activities for the LSUS component of designated projects in accordance with the scope of work and contracted timelines in line with the SSU portion of the study budget. Assist with the formulation, implementation, and operational integration of strategic and departmental goals and objectives. The Associate Director of SSU works with the Director of SSU and the Sr. Director Global ISS to prepare forward looking strategy for the SSU Department as it strives to meet its internal objectives to support overall Novella top and bottom line performance.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Assist in formulation of strategic initiatives and work with functional management to develop implementation plans, including regulatory and start-up evaluation measures.
  • Interface with internal contacts to determine operational strategy and/or expectations and parameters for key deliverables.
  • Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
  • Provide overall guidance and oversight of LSUS, supporting Study Start-Up Managers and other SSU team members in study management activities, including risk mitigation, operational implementation, resourcing, and budget management
  • Collaborate with the Strategic Regulatory Management team to determine baseline metrics to support the SSU teams in determining regulatory strategy/expectations/parameters for creating SSU Plans. 
  • Provide oversight to LSUS team to troubleshoot risks and challenges at the project level.  Assist teams in developing plans to address challenges.  Provide oversight of LSUS team to ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information.
  • Deliver presentations/training to clients, colleagues and professional bodies, as required.
  • Provide support in Proposal Management with input on proposals and budget development for start-up components of projects, as needed. Attend proposal defenses as needed.
  • Liaise with clients to ensure operational efficiency; implement updates to processes to ensure maximum efficiency and customer satisfaction.
  • Works with SSU Leadership team to implement QC/QA processes that are effective in providing high quality deliverables to our internal and external teams.
  • Assist with audits and provide recommendations and assist in the implementation of Corrective Action Plans.
  • Review and analyze performance metrics and processes to provide input in the development and implementation of process/system improvements.
  • Accountable for LSUS team efficiency and adherence to standard operating procedures (SOPs), Work Instructions, and project instructions and timelines.
  • Manage the selection and on-boarding process for new employees by conducting candidate review and participating in the interview process. Ensure employees have the appropriate materials, systems access and training to complete job responsibilities
  • Manage employees in accordance with organization’s policies and applicable laws. Responsibilities include planning, assigning and directing work of employees; appraising performance and guiding professional development; ensuring SOP and timesheet compliance; addressing employee relations issues and resolving problems. Approve actions for all management / human resource matters.
  • Resource employees efficiently to ensure achievement of utilization and budget targets.
  • Support the financial management of projects in start-up through estimate at completion reviews.  Work with SSU Managers to ensure changes in scope are identified, documented and escalated to Project Managers. 

KNOWLEDGE, SKILLS & ABILITIES:

  • Working knowledge of current clinical trial regulations, globally
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
  • Excellent knowledge of budget management and resourcing
  • Considerable working knowledge of medical terminology
  • Expert knowledge in study start-up in the clinical trial industry
  • Effective communication, organizational, interpersonal, and leadership skills
  • Excellent negotiating skills
  • Ability to lead and motivate teams
  • Excellent presentation skills
  • Ability to independently coordinate and manage new processes
  • Exceptional ability to conceptualize, develop and manage timelines
  • Ability to manage multiple projects and priorities.
  • Ability to set baseline targets, track trends and implement mitigation plans
  • Ability and willingness to travel
  • Knowledge of global regulatory processes and issues affecting study start up
  • Ability to work independently, prioritize and work with in a matrix team environment is essential
  • Ability to work cross functionally to achieve a desired project outcome
  • Working knowledge of Word, Excel, and PowerPoint required 
  • Working knowledge of Study Start-up tracking systems, resourcing systems, and financial management systems preferred
  • Excellent written and verbal communication skills are required
  • Ability to travel periodically if needed

#LI-AP22

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

Job posted: 2021-04-27

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