Vacancy expired!
Position Purpose:A Senior Clinical Project Manager (Sr CPM) is
responsible for the execution of a clinical trial or suite of clinical
trials from protocol design to the final clinical study report. The
position is responsible for coordinating all efforts for the trial both
within the Company and through a wide variety of vendors. A Sr CPM
coordinates other functional groups that comprise the clinical
department indication team for the product; specifically, statistics,
clinical monitoring, data management, medical writing, medical and
safety to insure proper conduct and timely completion of all
projects.Organizational Relationships: Reports to Parexel Line Manager
with day-to-day direction from the Client. Liaises with cross
functional lines as appropriate.Primary Duties:The goal of a Senior CPM
is to drive development projects utilizing best practices in order to
ensure budgets, timelines and performance requirements are met. Judgment
is required to meet GCP, regulatory and SOPs and policies and to
determine appropriate action. The role requires active involvement, to
meet schedules or resolve problems or conflicts, and entails frequent
interaction with subordinates, outside customers, functional peer groups
at various management levels and senior management. Gaining project team
cooperation, conducting presentations of technical information
concerning specific projects and schedules and, solving technical
problems, are keys to success. Specific duties include but are not
limited to: Manages cross functional project teams derived from the
groups within clinical development to deliver a high-quality clinical
trial(s). Drives all aspects of the project management process from
initiation, planning, execution, control and closure. Manages all
aspects proactively. Assists in developing protocol concept sheet
(study design, entry criteria and schedule of activities table). Reviews
protocol and CRFs and tracks development to completion. Creates
project budgets and manages cost to budgets. Develops enrollment
projection, and drug supply needs as part of the budget. Responsible
for creating and maintaining MS Project timelines for each project and
uses these timelines to track and manage a project's progress.
Responsible for creating Project Plans (e.g. Responsibility Table, and
Communication Plans) and Study Data Sheet for each project. Reviews
and approves the site contract template and budget template. Will review
and approve any variations to the template. Reviews study-related
support materials created by the Monitoring and Data Management Groups
(e.g. study manual, monitoring plan, edit check manual, Listing Review
process). Reviews actual trial conduct and quality at all levels (i.e.
monitoring, data management). Responsible for periodic (weekly, or as
needed) clinical trial team meetings. Reviews study metrics for
performance and quality with the team and management. Ensures review
of Clinical Trial Master File for completeness. Position has overall
responsibility to deliver the projects on time and on budget. The CPM
drives study conduct to timely completion in compliance with all
regulations and SOPs. Requires the ability to negotiate and manage
competing priorities across multiple functional areas. Works with
functional areas on initiating, planning, executing, controlling,
closing and resourcing clinical trial projects. The CPM acts as an
operational nexus or focal point for interdepartmental and
intradepartmental groups (e.g. stats, data management, safety,
manufacturing, regulatory), coordinating these different groups in a
matrix environment to drive and complete clinical programs. Insures
all groups provide deliverables (i.e. query generation and resolution,
data base lock, study report). Informs all groups of deliverables and
timeline, project developments and insures completion according to
timelines. Manage For full nfo follow application link.
Full-time