Clinical Scientist- Immunology & Pulmonology (Sr Manager)
Company: Disability Solutions
Location: Madison
Posted on: October 19, 2024
Job Description:
Working with UsChallenging. Meaningful. Life-changing. Those
aren't words that are usually associated with a job. But working at
Bristol Myers Squibb is anything but usual. Here, uniquely
interesting work happens every day, in every department. From
optimizing a production line to the latest breakthroughs in cell
therapy, this is work that transforms the lives of patients, and
the careers of those who do it. You'll get the chance to grow and
thrive through opportunities uncommon in scale and scope, alongside
high-achieving teams rich in diversity. Take your career farther
than you thought possible.Bristol Myers Squibb recognizes the
importance of balance and flexibility in our work environment. We
offer a wide variety of competitive benefits, services and programs
that provide our employees with the resources to pursue their
goals, both at work and in their personal lives. Read more: .The
Clinical Scientist function provides scientific expertise necessary
to design and deliver clinical studies and programs.Position
Summary / Objective
- Will be responsible for design and execution of assigned
clinical trial activities and work closely with clinical team
members within the assigned project to execute activities
associated with the conduct
- May serve as Clinical Trial Lead for one or more trials
- May lead or support trial level activities for one or more
trials with the necessary supervision
- May co-lead study team meetings in partnership with GDO
protocol manager and collaborate with cross-functional study team
membersPosition Responsibilities
- Collaborate and liaise with external partners (e.g., KOLs)
- Seek out and enact best practices with instruction
- Provide regular and timely updates to manager/management as
requested
- Develop Protocol and ICF documents / amendments and present
these to governance committee and development team meetings as
required
- Conduct literature review
- Submit clinical documents to TMF
- Develop site and CRA training materials and present these at
SIVs and Investigator meetings
- Review clinical narratives
- Monitor clinical data for specific trends
- Develop Data Review Plan in collaboration with Data
Management
- Ensure CRF design adequately supports data collection in
alignment with the protocol in collaboration with Data
Management/Programming
- Submit clinical contributions to clinical study reports (CSRs)
and clinical portions of Regulatory Documents (e.g., IB, DSUR,
PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute
to regulatory submission.)Degree Requirements
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other
scientific field preferred). Appropriate for new entrance to pharma
(post fellowship/ new to industry)Experience Requirements
- Basic knowledge of GCP/ICH, drug development process, study
design, statistics, clinical operations
- Ability to understand assigned protocol(s) and their
requirements
- Basic knowledge skills to support program-specific data review
and trend identification
- Intermediate medical writing skills and medical
terminology
- Basic planning/project management skills (develop short range
plans that are realistic and effective)Key Competency Requirements
- Detail-oriented with commitment to quality
- Basic knowledge of disease area, compound, current clinical
landscape
- Basic knowledge of the establishment and operation of data
monitoring committees, dose review teams, and independent response
adjudication committees
- Intermediate critical thinking and problem-solving skills
- Adaptable / flexible (willing and able to adjust to multiple
demands and shifting priorities; ability to meet day-to-day
challenges with confidence and professionalism)
- Intermediate skills in Microsoft Word/Excel/PowerPoint and data
review tools (e.g., Pt Profiles, report generating tools)Travel
RequiredDomestic and International travel may be
required.#li-hybridIf you come across a role that intrigues you but
doesn't perfectly line up with your resume, we encourage you to
apply anyway. You could be one step away from work that will
transform your life and career. Uniquely Interesting Work,
Life-changing CareersWith a single vision as inspiring as
Transforming patients' lives through science--- , every BMS
employee plays an integral role in work that goes far beyond
ordinary. Each of us is empowered to apply our individual talents
and unique perspectives in an inclusive culture, promoting
diversity in clinical trials, while our shared values of passion,
innovation, urgency, accountability, inclusion and integrity bring
out the highest potential of each of our colleagues.On-site
Protocol BMS has a diverse occupancy structure that determines
where an employee is required to conduct their work. This structure
includes site-essential, site-by-design, field-based and
remote-by-design jobs. The occupancy type that you are assigned is
determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned
facility. Site-by-design roles may be eligible for a hybrid work
model with at least 50% onsite at your assigned facility. For these
roles, onsite presence is considered an essential job function and
is critical to collaboration, innovation, productivity, and a
positive Company culture. For field-based and remote-by-design
roles the ability to physically travel to visit customers, patients
or business partners and to attend meetings on behalf of BMS as
directed is an essential job function. BMS is dedicated to ensuring
that people with disabilities can excel through a transparent
recruitment process, reasonable workplace
accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace
accommodation/adjustment prior to accepting a job offer. If you
require reasonable accommodations/adjustments in completing this
application, or in any part of the recruitment process, direct your
inquiries to . Visit to access our complete Equal Employment
Opportunity statement. BMS cares about your well-being and the
well-being of our staff, customers, patients, and communities. As a
result, the Company strongly recommends that all employees be fully
vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest
and conviction records, pursuant to applicable laws in your area.If
you live in or expect to work from Los Angeles County if hired for
this position, please visit this page for important additional
information: Any data processed in connection with role
applications will be treated in accordance with applicable data
privacy policies and regulations.
Keywords: Disability Solutions, Fairfield , Clinical Scientist- Immunology & Pulmonology (Sr Manager), Executive , Madison, Connecticut
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