Senior Clinical Trial Manager
Company: Incyte Corporation
Posted on: February 25, 2021
The Drive to Discover. The Experience to Deliver. Looking for a
challenge and a chance to grow your career? Then Incyte is the
pharmaceutical company for you. While our pipeline demonstrates the
ability to compete with much larger pharmaceutical companies in
selecting compelling targets and creating high-quality drug
candidates, our smaller size enables employees to see the direct
impact of their contributions on the direction of the company.--Due
to our smart, agile culture and cutting-edge science, we--delivered
a novel, first-to-market product in an unmet medical need in 2011 -
the first in the company's history. Opportunities for taking on new
and/or additional responsibilities, in addition to advancement, are
a key element in our culture. Add to that a science-based,
fast-paced work environment and you've got an exciting company in
which to work. In addition to opportunities for growth, we offer an
outstanding--benefits --andcompensation --package to help meet
personal needs as well. Incyte Corporation values the talents of
our diverse workforce and is proud to be an Equal Opportunity
Employer. 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 Senior Clinical Trial Manager provides input to the overall
operational trial(s) implementation, manages trial(s) timelines,
budget, feasibility, country identification and sites selection,
enhanced patient recruitment, functions as the primary liaison for
internal stakeholders and vendors leads multidisciplinary
departments initiatives, and provides support for process changes
to increase efficiency in study executions. Essential Functions of
the Job (Key responsibilities)
- Ensure adherence to Good Clinical Practice and all applicable
local and international regulations.
- Accountable to deliver Trial(s) on time, within budget, and
with highest achievable quality.
- Mange the conduct of clinical Trial(s) and provide operational
leadership within an outsourced, CRO model.
- 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.
- Manage the evaluation and selection of investigative
- Select, coordinate and monitor activities of CRO and associated
- Review of monitoring reports and conduct co-monitoring visits,
- Develop and manage trial(s) timelines, budget and project
- Participate in data management activities, including data
review and discrepancy resolution.
- Ensure set up and maintain all systems that implement trial(s)
and track progress throughout the duration of the program.--
- Generate necessary reports to update leadership on conduct of
- Ensure appropriate clinical trial supplies are ordered in time
and supply plans are implemented and managed.
- Develop recruitment plans, risk-mitigation plan, monitor, and
implement contingencies as required.
- Participate in monitoring study safety.--
- Develop key study quality metrics (e.g., protocol deviations
per site; number of queries per site, number of SOP deviation for
the study, number of data base migrations 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 the Clinical Scientist, Medical Monitor, CRA and other
third party vendor training on protocols and practices.
- Lead the multi-disciplinary teams in operational study team
- 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, to improve the
efficiency, effective and quality of the functioning of the
Development Operations Department.
Qualifications (Minimal acceptable level of education, work
experience, and competency)
- BS/BA degree or a relevant degree with strong emphasis on
- Minimum of five years of experience in the biopharmaceutical
industry or other relevant clinical research experience in the
conduct and management of multinational clinical trials.
- Able to manage complex and/or large trials.
- Demonstrated ability to manage complex and/or large trials in
an outsourced, CRO model a plus.
- 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, critical thinking, time management 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
- Good planning, prioritization, problem solving and
organizational skills; strong customer-orientation, used to work
- Strong communication skills, used to communicate with a broad
range of stakeholders and to build strong positive
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. The 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 firstname.lastname@example.org if you
have any questions or concerns or would like to exercise your
Keywords: Incyte Corporation, Boston , Senior Clinical Trial Manager, Executive , Wilmington, Massachusetts
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