***Regulatory & Start-Up Specialist (f/m) - Specialized in Ethics and Submissions - office based in Frankfurt or Freiburg/Br.*** in Germany at IQVIA™

Date Posted: 11/12/2018

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.
We currently have an exciting job opportunity as Regulatory & Start-Up Specialist, Junior RSU Specialist or Senior RSU Specialist (f/m) to work mainly in the field of ethics and submissions in our Regulatory & Start-up Department in Frankfurt or Freiburg/Br.  
 
 
RESPONSIBILITIES
 
  • Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines. Where applicable, act as a Country Lead for projects with no regional Lead assigned.
  • Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
  • Ensure regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
  • 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.
  • May contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
  • 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.


Job Requirements

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.
 
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor’s Degree or apprenticeship in life science or a combination of education and experience
  • For a Junior Specialist position at least a training in clinical research or law; for a Specialist role at least 3 years of regulatory start-up/submission experience, for a Senior Specialist position at least 5 years of experience.
  • Fluent languages skills in German and good command of English.
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: 1808649