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Senior Clinical Manager, FSP(m/w/x)
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
- German – Advanced
- English – Advanced
Tools & Technologies
- ICH/GCP
- FDA guidelines
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Senior Clinical Manager, FSP(m/w/x)
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
- German – Advanced
- English – Advanced
Tools & Technologies
- ICH/GCP
- FDA guidelines
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
HRA 11164 PPD Germany GmbH & Co KG
Industry
Healthcare
Description
The company enables customers to make the world healthier, cleaner and safer through clinical research and development.
Not a perfect match?
- Becton Dickinson
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