Senior Project Manager
Company: ICON Strategic Solutions
Location: Cheyenne
Posted on: May 27, 2023
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Job Description:
ICON plc is a world-leading healthcare intelligence and clinical
research organisation. From molecule to medicine, we advance
clinical research providing outsourced services to pharmaceutical,
biotechnology, medical device and government and public health
organisations. With our patients at the centre of all that we do,
we help to accelerate the development of drugs and devices that
save lives and improve quality of life. Our people are our greatest
strength, are at the core of our culture, and the driving force
behind our success. ICON people have a mission to succeed and a
passion that ensures what we do, we do well.
The Sr Project Manager (Sr. CTM) is responsible for oversight,
coordination, and execution of clinical trials in support of
clinical programs in Phases I-IV of development
Duties and Responsibilities:
Clinical project team member: works closely with the Clinical
Program Manager and is responsible for leadership, oversight,
planning, and execution of assigned clinical studies, timelines,
and key deliverables.
Works closely with Clinical Outsourcing on selection of CROs and
vendors, RFI, RFP and bid defenses, and co
Oversees and works directly with CROs, vendors, field monitors and
other partners. Establishes and maintains strong relationships with
investigators, study coordinators, site personnel and other
external key stakeholders.
Accountable for developing and managing study budgets and financial
reporting, including month end and quarterly flash reporting,
financial reconciliation, accruals, and re-forecasting, with
Clinical Outsourcing, Finance and Project Management.
Responsible for study status and timelines, and feeds data into
performance metrics reporting for assigned clinical projects.
Works with Patient Recruitment department and is responsible for
overall recruitment strategy, enrollment projections, and meeting
established targets.
Oversees and/or participates in development of clinical study
documents including ICF, monitoring plans, recruitment plans, and
other program/study related documents.
Leads and participates in internal cross-functional clinical team
meetings; serves as main point of contact for study-level status
updates.
Presents at management meetings, clinical team meetings and other
forums on study progress.
Works with Study Start-up and coordinates study start-up activities
including feasibility, investigational product and materials
preparation, trial master file setup, CRFs, regulatory documents,
and site contracts in conjunction with other relevant
departments.
Participates in database creation and user acceptance testing,
provides input for edit checks, monitoring guidelines, and data
cleaning activities between study sites, data management and field
monitors.
Participates in SOP development, process mapping, training of
junior CTMs and CTAs, and other departmental activities.
Direct line management and supervision of CTMs and/or CTAs.
Responsible for performance reviews and supporting professional
development for direct reports.
Education and Skills required:
8 years of relevant experience
Minimum 5 years of experience in clinical research, including a
minimum of 2 years full service project management experience or an
equivalent combination of education and experience sufficient to
successfully perform the key responsibilities of the job.
Reads, writes and speaks fluent English; fluent in language of host
country.
Preferred Education and skills:
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of
our people. That's why we are committed to developing our employees
in a continuous learning culture - one where we challenge you with
engaging work and where every experience adds to your professional
development.
At ICON, our focus is to provide you with a comprehensive and
competitive total reward package that comprises, not only an
excellent level of base pay, but also a wide range of variable pay
and recognition programs. In addition, our best in class employee
benefits, supportive policies and wellbeing initiatives are
tailored to support you and your family at all stages of your
career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive
employer and is committed to providing a workplace free of
discrimination and harassment. All qualified applicants will
receive equal consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, national
origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a
reasonable accommodation for any part of the application process,
or in order to perform the essential functions of a position,
please let us know.
#LI-MH3
#LI-Remote
Keywords: ICON Strategic Solutions, Cheyenne , Senior Project Manager, Executive , Cheyenne, Wyoming
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