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HRHRA 11164 PPD Germany GmbH & Co KG

Senior Clinical Manager, FSP(m/w/x)

Karlsruhe
Full-timeWith Home OfficeManagement

Leading clinical trial staff selection and development for life-changing therapies. Advanced mentoring and leadership skills required. On-site work with rotating construction sites.

Requirements

  • Bachelor's degree or equivalent qualification
  • 5+ years of relevant experience
  • 2+ years leadership responsibility, ideally in FSP
  • Equivalency of education, training, and experience considered
  • Advanced mentoring, leadership, supervisory skills
  • Excellent clinical trials monitoring skills (remote and on-site)
  • Understanding of company SOPs, WPDs, and regulations
  • Ability to evaluate medical research data
  • Strong organizational and negotiation skills
  • Strong attention to detail
  • Advanced written and oral communication skills
  • Good German and English language skills
  • Computer use for data entry, archival, retrieval
  • Ability to travel as needed
  • Excellent team player with team building skills
  • Excellent interpersonal and conflict resolution skills
  • Advanced problem-solving skills for changing environments
  • Solid knowledge of medical/therapeutic areas and terminology
  • Manages experienced professionals and/or subordinate management
  • Preferential treatment for severely disabled applicants with aptitude
  • Severely disabled applicants preferred with equal aptitude

Tasks

  • Manage and select staff
  • Train and resource staff
  • Coach and performance-manage staff
  • Lead or contribute to department initiatives
  • Collaborate with senior management on strategic planning
  • Act as point-of-escalation for performance concerns
  • Ensure adherence to SOPs and WPDs
  • Provide work direction and mentorship
  • Conduct performance appraisals and career discussions
  • Facilitate employee career development
  • Interview, recruit, and select staff
  • Conduct induction programs for new employees
  • Maintain staff CVs, training records, and position profiles
  • Ensure timely and accurate timesheets and expense reports
  • Support local resourcing activities
  • Optimize operational running of projects
  • Escalate issues impacting project deliverables
  • Deliver training on WPDs and SOPs
  • Identify and address training gaps
  • Contribute to training program development
  • Ensure adherence to ethical and regulatory standards
  • Alert management to quality issues
  • Request and facilitate QA audits
  • Review systems for employee and project metrics
  • Evaluate staff performance
  • Conduct MAST visits to assess monitoring skills
  • Participate in process improvement initiatives
  • Facilitate risk-based monitoring approach
  • Provide input into bids and new business procurement
  • Interpret and administer policies and procedures
  • Perform individual tasks as assigned
  • Interact with internal and external representatives
  • Resolve operational and scheduling issues

Work Experience

  • 5 years

Education

  • Vocational certificationOR
  • Bachelor's degree

Languages

  • GermanAdvanced
  • EnglishAdvanced

Tools & Technologies

  • ICH/GCP
  • FDA guidelines
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of HRA 11164 PPD Germany GmbH & Co KG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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