PURPOSE
Manage
the execution of the assigned medium to large multi regionally-based
phase IIIb-IV clinical study(ies) per Contract, from initiation through
to closeout. Ensure that all clinical study management and project
deliverables are completed to the Sponsor’s satisfaction, ensuring
quality deliverables on time and within budget and in accordance with
SOPs, policies and practices.
RESPONSIBILITIES
Manage and
co-ordinate efforts of cross-functional project teams to support
milestone achievement and to manage study issues and obstacles. Ensure
consistent use of study tools and training materials and compliance with
standard processes, policies and procedures. Implement continuous
improvement activities for assigned projects.
Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance.
Serve as primary project contact with Sponsor to ensure communication
is maintained and continuously improved and reporting schedules are
adhered to.
Report on team performance against contract, customer expectations, and project baselines to management.
Lead problem solving and resolution efforts to include management of
risk, contingencies and issues. Develop proactive contingency plans to
mitigate clinical risk.
Identify quality issues within the study
through regular review of site communications, monitoring visit reports,
data flow information and quality assurance audit findings to implement
appropriate corrective action plans. Escalate findings and action plans
to appropriate parties.
Collaborate with other functional groups
within the company where necessary to support milestone achievement and
to manage study issues and obstacles.
Provide input for the development of proposals for new work and project budgets.
Provide input to line managers of their project team members’
performance relative to project tasks. Recommend team members’ further
professional development. Support staff development. Mentor less
experienced CPMs.
Ensure high performance and efficiency of the
clinical team through the scheduling of co-monitoring/accompanied site
visits and ongoing mentoring of CRA team.
Prepare and present project information at internal and external meetings.
Participate in proposal development. May lead bid defense presentations
in partnership with Business Development and Senior Clinical Project
Management staff.
Define project workloads and assignments. Develop and oversee maintenance of internal databases and project plans
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In depth knowledge of, and skill in applying, applicable clinical
research regulatory requirements; i.e., Good Clinical Practice (GCP) and
International Conference on Harmonisation (ICH) guidelines
In depth therapeutic and protocol knowledge
Strong communication and interpersonal skills, including good command of English language
Strong organizational and problem solving skills
Demonstrated ability to deliver results to the appropriate quality and timeline metrics
Good team leadership skills
Effective mentoring and training skills
Excellent customer service skills
Good judgment
Effective presentation skills
Ability to manage competing priorities
Strong software and computer skills, including MS Office applications
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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