• Manager , Regulatory & Start-Up Jobs in Germany - 23845967

  • Iqvia
  • Germany
  • Save Job
  • 7 - 10 Years
  • Posted : above 1 month

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


This is a crucial high-profile role within IQVIA and the opportunity to progress your career in clinical research You will manage a team of RSU Specialists and overall activities for the start-up activities for clinical trials in Germany It is a broad role which requires strong communication skills and collaboration with other functional teams in a global environment to ensure competitive cycle times and delivery of projects within the scope of work, budget and contracted timelines As Manager, RSU (f/m), you will be accountable for and involved in all operational aspect of an effective project delivery, hence solid understanding of the clinical research environment in Germany is desired As a person you enjoy building relationships and you enjoy working cross-functionally and internationally You are also able to dig into details when needed to improve processes and to ensure staff compliance with ICH-GCP and company SOPs You will be responsible for development plans, coaching and performance reviews for direct reports


Provide Proposal Management with input on proposals and budget development for RSU component of projects Attend proposal defenses as needed
Where applicable, review and ensure project instructions for RSU projects are complete and accurate, including local requirements as appropriate Provide feedback to employees in the writing of project work instructions
Resource employees efficiently to ensure achievement of utilization and realization targets
Review and analyze performance metrics and processes to provide input in the development and implementation of process/system improvements
Accountable for employee efficiency and adherence to standard operating procedures (SOPs), work instructions, and project instructions and timelines
Manage employees in accordance with organizations policies and applicable laws Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems Approve actions for all management / human resource matters
Mentor employee and ensure adherence to project timelines, scope of work and budget
Serve as lead for single projects or programs as necessary
Serve as advisor for designated clients as necessary Provide RSU oversight across protocols / programs Serve as point of contact for issue escalation and process alignment
Participate in the selection and on-boarding process for new RSU 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
Support team to ensure that they successfully complete mandatory Compliance and GCP training and pass related exams
Assist with audits and provide recommendations and assist in the implementation of Corrective Action Plans


Full knowledge of drug development process
Full knowledge of applicable regulatory requirements, SOPs, and companys Corporate Standards
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
Strong knowledge of budget management and resourcing
Strong working knowledge of medical terminology
Strong knowledge of Microsoft Office and e-mail applications
Fluent spoken and written language skills in German and in English
Effective communication, organizational, interpersonal, and leadership skills
Strong negotiation skills
Ability to independently coordinate and manage new processes
Ability to lead and motivate teams
Ability to handle management/personnel issues
Ability to work independently and to effectively prioritize tasks
Ability to work well within a matrix team environment
Ability to establish and maintain effective working relationships with co-workers, managers and client


Bachelors degree, preferred in Healthcare or other scientific discipline and 7 years of clinical trials experience, preferable including 3 years experience in a leadership capacity, a broad understanding of general management practices desirable (eg The Oz Principle, The 4 Disciplines of Execution); or equivalent combination of education, training and 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 R1097527

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Consulting Services
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 18th Apr 2020

Key Skills:

Why not try out our free online tutorials and gain an edge?

People who search this job also searched for the following Keywords


All rights reserved © 2018 Wisdom IT Services India Pvt. Ltd DMCA.com Protection Status