Project Manager / Sr Project Manager- Immunology/Complex Dermatology-(20006674)
The position provides
customer focused leadership in managing and delivering the operational and
financial aspects of one or more clinical projects from proposal development to
final deliverables and ranging in size and complexity from single service
studies to full scope, multiple protocol projects and/or global projects across
various phases and functional areas with limited interaction from supervisor.
May oversee less experienced Project Managers (PMs) and have line management
Leadership and Delivery:
Manages a project as Project Manager overseeing interdisciplinary
clinical research programs ensuring compliance with Good Clinical Practices (GCPs),
relevant Standard Operating Procedures (SOPs) and regulatory requirements.
Acts as primary liaison between the Company
and the Customer to ensure project launch, conduct, and closeout according to
the Customer’s and the Company's contractual agreement.
Leads clinical team to ensure quality, timelines and budget management.
Accountable for all project deliverables for assigned projects and/or
Coordinates activities and deliverables of all project conduct partners
and proactively identifies and manages issues.
Accountable for maintenance of project information on a variety of
databases and systems.
Maintains and evaluates project progress by maintaining timelines and
other tracking/analysis tools.
Responsible for project management components of inspection readiness
for all aspects of the project conduct, including Trial Master Files.
Provides oversight for development and implementation of project plans in accordance with Controlled Documents.
Independently prepares, coordinates, and presents project material at
internal and external meetings.
Directs the activities of assigned Project Support staff; line manages
and mentors other project management team members and clinical
staff; facilitates team building and communication.
Prepares project management reports for clients and management.
Implements resource strategies to achieve project goals.
Develops contingency planning and risk mitigation strategies to ensure
successful delivery of project goals.
Participates in bid defense meetings where presented as potential
Develops strong relationships with current
clients to generate new and/or add-on business for the future.
Keeps a current awareness of business
unit’s and assigned projects’ therapeutic environment and drug development
May train and support new Project
Managers. Facilitates team training in
accordance with protocol and/or project requirements, including
therapeutic, protocol specific, and process training.
May be required
to line manage other project management team members and clinical monitoring
Bachelor’s Degree (or equivalent) level of qualification in
life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory
requirements, drug development process and clinical monitoring procedures.
Clinical research organization
(CRO) and relevant therapeutic experience preferred.
Strong ability to manage time and work independently.
Ability to embrace new technologies.
Excellent communication, presentation, interpersonal skills, both
written and spoken.
Flexibility and the ability to mentor and manage new staff and to handle
multiple tasks to meet deadlines delivering high quality work in a dynamic
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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