Top 3 Skill Sets Needed :
• provided project management for projects /initiatives/teams;with experience communicating project status, changes, and/or issues.
• require knowledge of project management tools and processes (e.g. MS Project), also computer literacy, including word processing, presentation, and spreadsheet applications
• Previous Client experience preferred.
Job Summary:
•
The Clinical Study Planning Manager (CSP) is a Role within the development operations organization, and assists the Clinical Research Manager (CRM) and development functions in tracking, documenting, and ensuring quality and timely delivery of all clinical trial deliverables.
• The CSP is accountable for co-developing and monitoring the implementation of high-quality, realistic, cross-functional, clinical study timelines for Client drug development programs from study concept through completed clinical study report.
• This role ensures alignment with the Integrated Project Plan timelines managed by R&D Project Management, and works with the Clinical Research Manager and CST to monitor progress against the plan and against established process metrics.
Key Responsibilities include:
• Co-developing and validating study-specific timelines
• Accurately maintaining clinical study timeline information in Client data control systems (e.g., APECS)
• Assisting in all aspects of initiating, planning, executing, controlling, and risk management of all clinical trial activities
• Facilitating communication of information on clinical trial status, changes, and issues to team members and stakeholders (e.g., dept. heads)
• Contributing to the development of high performing CSTs and functional teams
• Leading special projects as assigned
• Rapidly identifying variances within clinical study timelines that require corrective action
• Adhering to all Client policies, clinical development processes, SOPs, and clinical project management processes
Day To Day Responsibilities / First 30 Days:
• The first 2 weeks would entail obtaining equipment, access to systems and training. The latter 2 weeks would include continued role training and training for specific assignments.
Employee Value Proposition:
• Selected candidate will gain experience working within a key Global Development Operations function supporting various aspects associated with clinical trial timeline management (including reporting, ensuring timeline quality management, system updates, etc.). Additional support for initiatives or ad hoc duties, as assigned.
Possible Extension:
• Likelihood of extension is possible.
Qualifications
• Doctorate degree
• Master s degree & 3 years of clinical experience
• Bachelor s degree & 5 years of clinical experience
• Associate s degree & 10 years of clinical experience
• High school diploma / GED & 12 years of clinical experience
Preferred Qualifications/ Skills :
• MS or advanced degree preferred.
• Knowledge of project management tools and processes (e.g. MS Project) and strong computer literacy, including word processing, presentation, and spreadsheet applications.
• Experience in working with teams in a matrix environment.
• Familiarity with project management principles and practices.
• Project Management Professional (PMP) certification.
• provided project management for projects /initiatives/teams;with experience communicating project status, changes, and/or issues.
• require knowledge of project management tools and processes (e.g. MS Project), also computer literacy, including word processing, presentation, and spreadsheet applications
• Previous Client experience preferred.
Job Summary:
•
The Clinical Study Planning Manager (CSP) is a Role within the development operations organization, and assists the Clinical Research Manager (CRM) and development functions in tracking, documenting, and ensuring quality and timely delivery of all clinical trial deliverables.
• The CSP is accountable for co-developing and monitoring the implementation of high-quality, realistic, cross-functional, clinical study timelines for Client drug development programs from study concept through completed clinical study report.
• This role ensures alignment with the Integrated Project Plan timelines managed by R&D Project Management, and works with the Clinical Research Manager and CST to monitor progress against the plan and against established process metrics.
Key Responsibilities include:
• Co-developing and validating study-specific timelines
• Accurately maintaining clinical study timeline information in Client data control systems (e.g., APECS)
• Assisting in all aspects of initiating, planning, executing, controlling, and risk management of all clinical trial activities
• Facilitating communication of information on clinical trial status, changes, and issues to team members and stakeholders (e.g., dept. heads)
• Contributing to the development of high performing CSTs and functional teams
• Leading special projects as assigned
• Rapidly identifying variances within clinical study timelines that require corrective action
• Adhering to all Client policies, clinical development processes, SOPs, and clinical project management processes
Day To Day Responsibilities / First 30 Days:
• The first 2 weeks would entail obtaining equipment, access to systems and training. The latter 2 weeks would include continued role training and training for specific assignments.
Employee Value Proposition:
• Selected candidate will gain experience working within a key Global Development Operations function supporting various aspects associated with clinical trial timeline management (including reporting, ensuring timeline quality management, system updates, etc.). Additional support for initiatives or ad hoc duties, as assigned.
Possible Extension:
• Likelihood of extension is possible.
Qualifications
• Doctorate degree
• Master s degree & 3 years of clinical experience
• Bachelor s degree & 5 years of clinical experience
• Associate s degree & 10 years of clinical experience
• High school diploma / GED & 12 years of clinical experience
Preferred Qualifications/ Skills :
• MS or advanced degree preferred.
• Knowledge of project management tools and processes (e.g. MS Project) and strong computer literacy, including word processing, presentation, and spreadsheet applications.
• Experience in working with teams in a matrix environment.
• Familiarity with project management principles and practices.
• Project Management Professional (PMP) certification.