customer-focused leadership in managing clinical projects across various
phases, functional areas and assigned clinical staff.Accountable for the successful execution of
all assigned projects, where success includes on-time, on-budget,
high-quality/compliant project results that lead to satisfied customers. May
have line management responsibilities.
Project Leadership and Delivery:
Manages a project as a project manager overseeing
interdisciplinary clinical research studies and ensures compliance with
GCP, relevant SOP’s, and regulatory requirements.
Acts as a primary liaison between the Company
and the Customer to ensure timely study launch, conduct, and closeout
according to the Customer’s and the Company’s contractual agreement.
Lead project team to ensure quality, timelines
and budget management.
Accountable for the financial performance of
Coordinate activities and deliverables of all
study conduct partners and proactively identify and manage issues.
Ensure studies are conducted in compliance
with GCP, relevant SOP’s and regulatory requirements.
Accountable for all project deliverables for
each project assigned.
Documentation and Reporting:
Responsible for quality and completeness of
TMF for assigned projects.
Accountable for maintenance of study
information on a variety of databases and systems.
Responsible for study management components of
inspection readiness for all aspects of the study conduct.
Oversight for development and implementation
of project plans.
Plan, coordinate and present at internal and
Prepare project management reports for clients
Developing contingency planning and risk
mitigation strategies to ensure successful delivery of study goals.
strong relationships with current clients to generate new and/or add-on
business for the future.
May participate in bid defense meetings where
presented as potential project manager.
May be required to line manage other project management team
members and clinical monitoring staff.
·Bachelor’s Degree (or equivalent) level of
qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent
combination of education and experience.
·Clinical research organization (CRO) and relevant
therapeutic experience preferred.Strong
knowledge of Good Clinical Practice/ICH guidelines and other applicable
·Strong organizational skills.
·Strong ability to manage time and work independently.
·Direct therapeutic area expertise.
·Ability to embrace new technologies.
·Excellent communication, presentation, interpersonal
skills, both written and spoken.
·Ability to travel as necessary (approximately 25%).
Tasks, duties, and responsibilities as listed in this job
description are not exhaustive. The Company, at its sole discretion and with no
prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so
qualifications of incumbents may differ from those listed in the Job
Description. The Company, at its sole discretion, will determine what
constitutes as equivalent to the qualifications described above. Further,
nothing contained herein should be construed to create an employment contract.
Occasionally, required skills/experiences for jobs are expressed in brief
terms. Any language contained herein is intended to fully comply with all
obligations imposed by the legislation of each country in which it operates,
including the implementation of the EU Equality Directive, in relation to the
recruitment and employment of its employees.
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