Associate Director, Clinical Data Standards
Company: Disability Solutions
Location: Princeton
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
Associate Director, Clinical Data Standards is a leadership role
with oversight to manage Standards Managers, determine resource
requirements, prioritize assignments and balance workload. The role
includes developing and communicating data standards implementation
strategy within department and across functions and directly
contributes to the BMS R&D pipeline.This role reports to
Director or Executive Director, Head Standards Management & Steward
within Clinical & Safety Data Insights and Analytics.Position
Responsibilities
- Providing leadership of clinical data standards activities
across multiple clinical development programs, overseeing a team of
standards professionals in planning, coordination, and timely
delivery of global standards elements for study database
consumption.
- Ensuring adaptive management of a standards team through the
effective deployment of resources and streamlined processes,
ensuring productivity targets, validity and quality of the data
gathered in support of the evolving portfolio of BMS products.
- Managing the book of work for global standards requests.
Assigning resources to standards requests and initiatives and
regularly monitoring workloads to avoid delays in delivery due to
resource constraints. Forecasting future resource needs based on
the book of work.
- Providing ongoing feedback, coaching, and career development,
including engagement and retention support to staff in order to
maximize their potential. Empowering and holding staff to high
quality performance and delivery.
- Ensuring procedural documents are reflective of industry
standards, easily followed, and regularly maintained.
- Contributing to the development and application of smart
systems and optimal approaches to support the end to end clinical
trial data lifecycle, from collection through submission.
- Holding accountability to resolve issues and proactively
develop solutions, within the functional and across functions.
- Actively participating in and/or leading continuous improvement
activities, defining and implementing the changes required to
create an industry-leading global standards competency.
- Engaging and energizing employees through communication of
goals, priorities and other business critical information as well
as focus on employee value proposition, development and retention
activities.
- Developing and promoting a work place culture that values
diversity of thought, promotes integrity and creates an atmosphere
that supports coaching and fosters accountability.
- Ensuring effective quality oversight and management of external
partners (e.g. Function Service Providers, CROs, technology
providers, etc.) performing standards activities on behalf of
BMS.
- Developing strong and productive working relationships with key
stakeholders throughout GDMCM, GCO, Global Biometrics & Data
Sciences, and BMS with the ability to think strategically across a
broad portfolio and effectively express his/her views to senior
management.
- Representing the Company in interactions with key external
partners as part of any committee or industry group relating to
data standards.Degree Requirements Bachelor's degree required with
an advanced degree preferred Experience Requirements
- At least 12 years of global clinical trial expertise and a
successful track record of leading through influence, working
across complex, global organizational matrices, including 3 yrs of
line management experience. Immuno-Oncology therapeutic experience
is highly desirable.
- Good understanding of the drug development process with proven
expertise in clinical trial execution and data acquisition as well
as analysis reporting in a global arena.
- Strong knowledge of industry clinical data standards and
processes (e.g., CDISC: CDASH/SDTM/ADaM, SDSP) and well versed in
industry best practice documentation from regulatory authorities
(e.g., Technical Conformance Guide, Standards Catalog, CDISC TAUGs,
etc.).
- Strong knowledge of industry leading eCRF tools (e.g., Medidata
Rave, Oracle, etc.) and well versed in industry trends and emerging
technologies supporting end to end solutions for data collection
through submission (e.g., Metadata Data Repositories, Data
Warehouse, Clinical Data Repository).
- Strong knowledge of GCP/ICH guidelines.
- Technical expertise, technical writing ability, and experience
in Systems Development Life Cycle (SDLC) principles.
- Demonstrated partnership across various collaborative forums,
CROs, SMOs and/or local site networks.
- Diverse and sufficient technical expertise to be a credible
interface to all global development and business partners (medical,
development, commercial, regulatory & quality etc.).
- Influential leadership and communication capabilities with a
proven ability to engage, manage, develop and inspire a
geographically diverse team. If 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 , Associate Director, Clinical Data Standards, Executive , Princeton, Connecticut
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