Clinical Trial Mgr to Associate Dir, Clinical Trial Head
Company: Incyte Corporation
Location: Wilmington
Posted on: August 6, 2022
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Job Description:
Incyte is a biopharmaceutical company focused on the discovery,
development, and commercialization of novel medicines to meet
serious unmet medical needs in oncology and inflammation and
autoimmunity. Incyte is committed to the rigorous pursuit of
research and development excellence to improve the lives of
patients, make a difference in health care, and build sustainable
value. The Company strives to discover and develop first-in-class
and best-in-class medicines-advancing a diverse portfolio of large
and small molecules.Job Summary (Primary function)The Clinical
Project Manager provides input to the overall operational trial(s)
implementation, manages trial(s) timelines, budget, feasibility,
country identification and sites selection, enhanced patient
recruitment, and functions as the primary liaison for internal
stakeholders and vendors.Essential Functions of the Job (Key
responsibilities) Accountable to deliver Trial(s) on time, within
budget, and with highest achievable quality. Assist in the review,
development and/or writing of clinical trial documents and manuals,
including but not limited to Protocol, Case Report Forms, informed
consent forms, Clinical Study Report and other regulatory
documents. Lead the evaluation and selection of investigative
sites; responsible for feasibility. Select, coordinate and monitor
activities of vendors Review of monitoring reports and conduct
co-monitoring visits, as needed. Develop and manage trial(s)
timelines, budget and priorities. Participate in data review and
discrepancy resolution. Ensure set up and maintain all systems in
order to plan and implement trial(s) and track progress. Generate
reports to update management on conduct of trial. Ensure
appropriate clinical trial supply plans are implemented and
managed. Develop recruitment plans, risk-mitigation plan, monitor,
and implement contingencies as required. Participate in monitoring
study safety. Review key study quality metrics (e.g., eligibility,
primary endpoint data, etc.) and determine appropriate action in
conjunction with study team. Perform initial review of CRO and
other third party study vendor invoices to ensure that work is
performed in accordance with scope of work. Assist with CRA and
third party vendor training on protocols and practices. Lead the
multi-disciplinary trials teams; include the study team meetings.
Function as the primary contact for trial(s) between Drug
Development and other departments. Assume responsibility to
participate as a member of working groups and perform special
projects, as assigned. Ensure adherence to Good Clinical Practice
and all applicable local and international
regulations.Qualifications (Minimal acceptable level of education,
work experience, and competency) BS/BA degree or a relevant degree
with strong emphasis on science. Minimum of four years of
experience in the biopharmaceutical industry or other relevant
clinical research experience in the conduct and management of
multinational clinical trials. Must have working knowledge of ICH
Good Clinical Practices and other relevant regulatory/health
authority experience. Ability to effectively manage multiple
priorities across several protocols and therapeutic areas
simultaneously. Demonstrate leadership and problem solving skills.
Experience in executing a wide range of clinical trial activities
(from initiation to clinical study report). Used to work in a
multidisciplinary setting, strong cooperative team player, ability
to be flexible and adapt to a changing environment. Good planning,
prioritization, problem solving and organizational skills; strong
customer-orientation, used to work independently. Strong
communication skills, used to communicate with a broad range of
stakeholders and to build strong positive relationships.Disclaimer:
The above statements are intended to describe the general nature
and level of work performed by employees assigned to this job. They
are not intended to be an exhaustive list of all duties,
responsibilities, and qualifications. Management reserves the right
to change or modify such duties as required.Incyte Corporation is
committed to creating a diverse environment and is proud to be an
equal opportunity employer.We Respect Your PrivacyLearn more at:
http://www.incyte.com/privacy-policyThe Incyte hiring organization
processes your personal data to manage your job application in
order to enter into an employment relationship with you if you are
the successful candidate. During the process, you may be asked to
respond to questions that will screen out your application if you
do not meet certain objective criteria required by the job. You can
learn more about this process here.You may have the right to
access, delete, restrict, edit, move, or object to the use of your
personal data. You may also have a right to report concerns to the
authority responsible for data privacy in the country where the
position is based or where you live or work. You can learn more
about Incyte's data protection practices here. By accessing this
link you can learn about the types of personal data we collect, how
we use it, whether collection and processing is optional, sources
of the personal data we process, how it is shared, where it is
stored or transferred to, how long we keep it, and contact
information for Incyte, Incyte's data protection officer, and your
supervisory authority (if applicable).Please contact
privacy@incyte.com if you have any questions or concerns or would
like to exercise your rights.
Keywords: Incyte Corporation, Wilmington , Clinical Trial Mgr to Associate Dir, Clinical Trial Head, Healthcare , Wilmington, Delaware
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