Everest Clinical Research (“Everest”) is a full-service contract research
organization (CRO) providing a broad range of expertise-based clinical research
services to worldwide pharmaceutical, biotechnology, and medical device
industries. We serve some of the best-known companies and work with many of the
most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a
statistical and data management center of excellence. Building on this
foundation, Everest has successfully developed and established itself as a
full-service CRO. Everest’s Corporate headquarters are located in Ontario,
Canada and US headquarters in New Jersey, USA, with additional physical offices
in Asia and Europe.
Everest is known in the industry for its high-quality deliverables, superior
customer service, and flexibility in meeting clients’ needs. A dynamic
organization with an entrepreneurial origin, Everest continues to experience
exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our
strength…that’s us…that’s Everest.
To drive continued success in this exciting clinical research field, we are
seeking a committed, skilled, and customer-focused individual to join our
winning team as an Associate Director, Project Management working remotely (or
in office).
Associate Director, Project Management:
This leadership role will oversee the project planning, communication and
execution of clinical research and development services offered by Everest.
Direct reports include those Project Managers and Senior Project Managers
assigned to report to the Associate Director, Project Management. In-direct
reports/subordinates are those Project Managers who are assigned to the tasks
overseen by the Associate Director, Project Management.
JOB ACCOUNTABILITIES:
Training, management, and oversight of Project Managers, including
performance assessments.
In consultation with the President of Everest, review new Project Manager
Applicants and recommend hires for interview processing.
Develop, update and review governing documents for use within this functional
area.
Plan and implement new client service delivery requests within client
portfolio; supporting evolution of existing client portfolio, providing
holistic biometrics deliveries across multiple clinical development programs.
In consultation with the President of Everest, further develop and establish
policies and SOPs in project management and assurance of quality
deliverables.
Facilitate the efforts of functional area directors and managers in project
planning, identification of tasks and deliverables, assessment of resource
needs and utilization.
Perform project progress tracking for responsible projects using strategic
planning and project tracking methods and tools. Provide monthly project
progress status reports for individual ongoing projects.
Check and ensure that responsible projects carried out at Everest will have a
properly tracked and periodically reported project plan, as required by the
established SOPs.
Conduct responsible project progress status meetings with individual project
teams periodically, with focuses and close attention to the projects which
require close follow up or immediate actions.
Through the periodic review meetings, issues such as lack of planning, lack
of resources, poor team performance, or other external factors negatively
impacting the ongoing projects, are promptly identified and brought to the
attention of the functional area directors and managers. Work with the
functional area directors and managers to jointly ensure smooth project
starting up, continuation, and successful completion.
In consultation with the President of Everest, interact with clients for
projection of resource requirements and project management purposes.
Manage projects with activities focused on data management, statistics,
medical writing, subject randomization and drug supply management (IWRS),
administration of data monitoring and adjudication committees, as well as
preparing drug submissions to regulatory agencies.
Integrate information to define work scopes and estimate budgets, develop and
manage cross-functional project work plans including resource requirements
and utilization, budgets, quality deliverables and timelines.
Manage all project management aspects of assigned Phase I -IV clinical trials
and in accordance to ICH guidelines, FDA, Health Canada, EMA, and other
applicable regulatory and legal requirements.
Lead cross-functional project teams. Manage the planning, implementation,
conduct and reporting of assigned projects within the established timelines
and budgets, and with the quality and requirements necessary for regulatory
approvals.
Coordinate activities between Everest and trial sponsors, and with various
supporting groups or vendors when necessary.
Proactively track and manage the financial status against budget and
reconcile expenses across sub-streams of activities.
Proactively track and manage project tasks against timelines and hours
spent/budgets, alert management when there are risks of having major
deviations.
Prepare project status reports and maintain accurate and current details.
Present project status to internal and external stakeholders.
Function as meeting facilitator for the meetings involving various internal
and external participants.
Function as facilitator of problem solving and conflict resolution.
Communicate project action items and key decisions through timely minutes and
follow up actions.
Conduct “lessons learned” meetings with project team members to learn from
failures and prevent same from future projects.
Contribute and/or participate in the performance evaluation of staff who
performed under the responsible projects.
When required, the incumbent may assist the organization in responding to and
preparing for Request for Information and Request for Proposals, and
subsequently defining work scopes and budgets, and performing contract
administration activities.
When required, perform clinical trial planning, management, and site
monitoring from the initiation of a trial to its closure.
QUALIFICATIONS:
B.Sc. or M.Sc. in life sciences or health related field.
12+ years’ experience in clinical research and development within a
pharmaceutical, biotechnology or CRO setting.
Line management experience required.
Demonstrated ability to lead and develop others within functional area.
Demonstrated understanding of cross-functional processes including clinical
operations, statistics, data management, subject randomization and drug
supply management, data monitoring and adjudication committees, regulatory
affairs, and medical writing.
Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA
regulations.
Ability to define scopes and estimate budgets, plan and manage projects,
including resource requirements and utilization, hours spent vs. budgets, key
deliverables and timelines.
Demonstrated leadership abilities, including setting goals for others and
driving to achieve them in accordance with allocated resources, timelines,
and budgets.
Excellent interpersonal, oral and written communication skills. Demonstrated
strong negotiation and presentation skills.
Strong ability in problem-solving including conflict resolution.
Experienced as a clinical trial monitor, initiating, monitoring and closing
out clinical trials will be desirable.
Benefits & Compensation:
We offer a robust benefits package to support your health, well-being, and
growth, including medical, dental, and vision coverage, life & AD&D insurance,
short- and long-term disability, tuition reimbursement, fitness reimbursement,
employee assistance program (EAP), a 401(k) retirement, generous paid time off
and sick leave, and the opportunity to earn a performance based bonus.
To find out more about Everest Clinical Research and to review other
opportunities, please visit our website at www.everestclinical.com
[http://www.ecrscorp.com].
Estimated Salary Range: $150,000 - 200,000.
We thank all interested applicants, however, only those selected for an
interview will be contacted.
Everest is committed to upholding the principles of dignity, independence,
integration, and equal opportunity. We welcome and encourage applications from
people with disabilities, and upon request we will provide accommodations for
candidates participating in any part of our recruitment and selection process.
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