• *Regulatory & Study Start-Up Specialist Jobs in Germany

  • Iqvia
  • Germany

Job Description:

We currently have an exciting opportunity as (Junior- / Senior-) Regulatory & Start-Up Specialist (m/w/d) to work in both fields of ethics and submissions and contracting and budget negotiations in our Regulatory & Start-up Department in Frankfurt or Freiburg/Br

A specialization in contracting and budgets would be possible as well

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
Review, prepare and negotiate site contracts and budgets with sites
Prepare site regulatory documents, reviewing for completeness and accuracy
Distribute completed documents to sites and internal project team members
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
Perform quality control of documents provided by sites
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

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
Fluent languages skills in German and good command of English

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelors Degree or apprenticeship in life science or a combination of education and experience; or a background in law or economics and contracting 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

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 R1055366

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Consulting Services
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 08th Apr 2020

Key Skills:

Company Profile:

Company
Iqvia

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