Manager, Oncology Clinical Data Review - REMOTE
Company: Precision For Medicine
Location: Portland
Posted on: May 17, 2022
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Job Description:
Precision medicine is revolutionizing the charge on cancer-and
we are passionate about helping you harness its power. We strike
tumors on a molecular level using biomarkers to link specific
mutations to specific treatments. We combine deep science with deep
data from advanced technological platforms, then layer on
specialized expertise in the design and execution of targeted,
adaptive clinical trials.
We offer an excellent compensation package, value our company
culture and career advancement opportunities. This position is 100%
remote!
The Manager will focus on the early and continuing scientific
review of clinical data in various formats by applying the protocol
and/or other applicable references along with oncology standards
for the indication being studied to support overall data quality
and consistency, allowing the for insights to support a continuous
risk management approach. Coordinate development of direct reports
by setting goals, conducting performance reviews, crafting
development plans, mentoring, and coaching
Responsibilities
Serves as the functional lead (core team member) representing the
group on assigned project team(s)
Lead all aspects of and supports Scientists in the review of
subject data for accuracy per protocol, associated references and
oncology standards of care and principles.
Coordinates and conducts targeted reviews and analyses of clinical
trial data sources early and ongoing throughout the trial to ensure
consistency, integrity and accuracy based on project specific
review guidelines with an emphasis on scientific and clinical
sense
Develops and maintains a good working relationship with internal
and external project team members, serving as an ambassador to
promote Precision's high quality and ethical image in accordance
with the company Core Values.
Serves as a resource for project teams regarding scientific,
clinical, oncology related questions supported by Medical
Monitoring
Assesses routine status updates on findings and intensifies issues
as appropriate with project team and Management
Supports the identification of quality risks and issues and
recommends corrective action plans as needed to address
deficiencies in performance throughout the life of the project
Leads and/or conducts UAT of programming output and participates in
EDC UAT
Provides review of the protocol from a scientific-operational
perspective detailed understanding of assigned protocol and
protocol requirements
Provides indication specific input into data capture and other
clinical trial document development (e.g., EDC specifications,
completion guidelines, edit checks, review guidelines, etc.)
Issues and resolves queries in various EDC systems when needed
Qualifications
Minimum Required:
Bachelor's degree or equivalent combination of education/experience
in science or healthcare field with proficiency in medical
terminology.
At least five (5) years (Manager level) or eight (8) years (Sr.
Manager level) in clinical operations, data management, safety or
related field in either the CRO or pharmaceutical industry with a
minimum of three (3) years on-site monitoring experience and/or
data review experience
Strong oncology therapeutic experience required with ability to
apply knowledge to the source data
Supervisory experience executing process, people and/or teams
Mastery level skill set in oncology clinical standards including
the application of disease assessment criteria, standard of care,
grading criteria, etc.
Experience with electronic data capture systems (EDC) and data
visualization tools
Preferred
Medical related degree, RN, OCN, RPH, PharmD, etc.
Any data provided as a part of this application will be stored in
accordance with our Privacy Policy .
Precision Medicine Group is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, age,
religion, sex, sexual orientation, gender identity, national
origin, disability, veteran status or other characteristics
protected by law. - 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable
accommodation to complete any part of the application process, or
are limited in the ability or unable to access or use this online
application process and need an alternative method for applying,
you may contact Precision Medicine Group at
QuestionForHR@precisionmedicinegrp.com .
Keywords: Precision For Medicine, Portland , Manager, Oncology Clinical Data Review - REMOTE, Healthcare , Portland, Oregon
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