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Local Trial Manager, Submissions Dedicated(m/w/x)
Managing clinical trial submissions and study delivery for life sciences clients. 2 years clinical research experience and submissions knowledge required. Support core project team, optimize study speed, quality, and cost.
Requirements
- Associate's degree in life sciences or related field
- Bachelor's degree in life sciences or related field
- 2 years clinical research experience
- Intermediate knowledge of job area principles, theories, and concepts
- Submissions and regulatory experience
- Knowledge of clinical trial conduct
- Skill in applying ICH GCP and relevant local laws/regulations
- Broad protocol knowledge
- Therapeutic knowledge desired
- Strong written and verbal communication skills
- Good command of English language
- Strong presentation skills
- Strong problem-solving skills
- Planning, time management, and prioritization skills
- Ability to organize resources
- Ability to set objectives and provide clear direction
- Experience planning activities in advance
- Ability to handle conflicting priorities
- Attention to detail and accuracy
- Results-oriented approach
- Good software and computer skills
- MS Office applications including Word, Excel, and PowerPoint
- Ability to establish and maintain effective working relationships
- Strong customer service skills
- Ability to work across geographies
- High awareness and understanding of cultural differences
- Good understanding of project financials
- Ability to demonstrate IQVIA competencies
Tasks
- Liaise with clinical teams to improve patient outcomes
- Support core project team in clinical study delivery
- Develop integrated study management plans with the team
- Manage assigned portion of clinical studies
- Optimize study speed, quality, and cost
- Ensure compliance with standard processes and policies
- Set and communicate sub-team objectives
- Assess sub-team performance
- Collaborate with functional groups to achieve milestones
- Monitor progress against contract
- Prepare and present project information to stakeholders
- Identify and manage project risks and contingencies
- Solve problems and implement corrective actions
- Serve as primary or backup project contact with customers
- Lead project sub-teams
- Manage cross-collaboration within sub-teams
- Support financial success of the project
- Forecast and identify revenue acceleration opportunities
- Manage changes in project scope
- Implement best practices and lessons learned
- Lead vendor management activities
Work Experience
- 2 years
Education
- Vocational certificationOR
- Bachelor's degreeOR
- Master's degree
Languages
- English – Advanced
Tools & Technologies
- MS Office
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
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Local Trial Manager, Submissions Dedicated(m/w/x)
Managing clinical trial submissions and study delivery for life sciences clients. 2 years clinical research experience and submissions knowledge required. Support core project team, optimize study speed, quality, and cost.
Requirements
- Associate's degree in life sciences or related field
- Bachelor's degree in life sciences or related field
- 2 years clinical research experience
- Intermediate knowledge of job area principles, theories, and concepts
- Submissions and regulatory experience
- Knowledge of clinical trial conduct
- Skill in applying ICH GCP and relevant local laws/regulations
- Broad protocol knowledge
- Therapeutic knowledge desired
- Strong written and verbal communication skills
- Good command of English language
- Strong presentation skills
- Strong problem-solving skills
- Planning, time management, and prioritization skills
- Ability to organize resources
- Ability to set objectives and provide clear direction
- Experience planning activities in advance
- Ability to handle conflicting priorities
- Attention to detail and accuracy
- Results-oriented approach
- Good software and computer skills
- MS Office applications including Word, Excel, and PowerPoint
- Ability to establish and maintain effective working relationships
- Strong customer service skills
- Ability to work across geographies
- High awareness and understanding of cultural differences
- Good understanding of project financials
- Ability to demonstrate IQVIA competencies
Tasks
- Liaise with clinical teams to improve patient outcomes
- Support core project team in clinical study delivery
- Develop integrated study management plans with the team
- Manage assigned portion of clinical studies
- Optimize study speed, quality, and cost
- Ensure compliance with standard processes and policies
- Set and communicate sub-team objectives
- Assess sub-team performance
- Collaborate with functional groups to achieve milestones
- Monitor progress against contract
- Prepare and present project information to stakeholders
- Identify and manage project risks and contingencies
- Solve problems and implement corrective actions
- Serve as primary or backup project contact with customers
- Lead project sub-teams
- Manage cross-collaboration within sub-teams
- Support financial success of the project
- Forecast and identify revenue acceleration opportunities
- Manage changes in project scope
- Implement best practices and lessons learned
- Lead vendor management activities
Work Experience
- 2 years
Education
- Vocational certificationOR
- Bachelor's degreeOR
- Master's degree
Languages
- English – Advanced
Tools & Technologies
- MS Office
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
IQVIA RDS GmbH
Industry
Pharmaceuticals
Description
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
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