Director, eCOA Management
$200.98k - $243.54kBristol Myers Squibb
Working with Us
Challenging. 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. 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:
careers.bms.com/working-with-us [ Position Summary The Director, eCOA Management is a leadership role accountable for the
operationalization of eCOA for BMS clinical trials and directly contributes to
the BMS R&D pipeline. This role reports to the Head of Clinical Data Acquisition within GDM and is
based in New Jersey. It is a full-time, office-based position with flexibility
to work from home up to 50% of the time. Position Responsibilities * Providing comprehensive leadership of the eCOA Management function ensuring
the technology, end to end processes, roles and vendor partnerships are
optimized and in line with industry standards and regulatory requirements. * Ensuring quality development and timely delivery of eCOA instruments and
devices that are designed in accordance with documented specifications, as
well as industry and BMS standards. Delivering eCOA for studies across
Therapeutic Areas, including complex Neuroscience rater studies. * Ensuring data acquired through eCOA meets quality standards, is readily
consumable by downstream functions and is reliable for analysis. * Ensuring processes related to acquisition and review of eCOA data are well
defined, comprehensive, consistent across vendors, and effectively executed
across all studies. This includes, but is not limited to, eCOA start up,
system development, scale management, localization/translations, device
shipments, data review/data changes, rater training/qualifications and
blinded data analytics and other Neuroscience rater study processes. * Streamlining document templates and communications and promoting consistency
across vendors. * Defining key quality and performance metrics and reviewing results to
proactively identify/implement improvements. * Leading initiatives to establish industry-leading eCOA capabilities and
processes, driving projects from start to finish. * Holding accountability to resolve complex issues and proactively develop
solutions, within the function and across functions. Using clear
communications and collaborative strategies to drive to resolution and remove
barriers. * Managing the eCOA book of work and ensuring delivery of initial development
and post-production changes for studies. Working with line managers to
forecast future resource needs and to resolve any resource constraints. * Leading a global team of eCOA Management professionals that contribute
significantly to the BMS portfolio of clinical trials. 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. * Engaging and energizing employees through recognition, development and
communication of goals/strategies. * Collaborating effectively with eCOA vendors to ensure quality and timely
delivery, including effective resolution of critical issues. Ensuring
business functionality that is important for BMS is clearly
identified/communicated to eCOA vendors and is effectively incorporated into
eCOA vendor release plans/roadmaps. * Representing the function for Health Authority inspections and internal
audits. Ensuring preparations and follow-up actions are being completed
effectively by the team. * Developing and promoting a workplace culture that encourages open dialogue,
upholds integrity, and supports coaching and accountability * Developing strong and productive working relationships with key stakeholders
throughout BMS, demonstrating the ability to think strategically across R&D,
and effectively influencing peers and senior management. * Representing the company with key external organizations as part of any
committee or industry group relating to eCOA. Degree / Experience Requirements Bachelor’s degree required with an advanced degree preferred
At least 10 years of relevant eCOA, end to end processes, and technology experience with specific expertise in implementing eCOA for complex
Neuroscience rater studies. * Successful track record of leading functions, managing staff, influencing
stakeholders and vendors, driving strategy and making decisions. Key Competency Requirements * Deep understanding of clinical trial processes with proven expertise in
end-to-end eCOA operationalization in a global arena. * Expert understanding of end-to-end processes for eCOA data acquisition,
review and delivery and what is required of eCOA data to support submissions
for studies across Therapeutic Areas including complex Neuroscience rater
studies. * Expert knowledge of industry trends and emerging technologies supporting
eCOA. Proven record of working effectively with multiple eCOA vendors.
Expert knowledge of GCP/ICH guidelines.
Proven record of proactively resolving complex issues, making decisions with an enterprise mindset, and driving significant initiatives to completion. * Demonstrated ability to deliver tangible impact by planning and executing
strategic projects involving cross-functional stakeholders. * Strong, clear oral and communication skills, including the ability to craft
communications and business cases for senior leadership. Demonstrated people management experience.
Proven experience with applying Systems Development Life Cycle (SDLC) and system validation principles to ensure data integrity and quality. Travel: Periodic travel can be expected 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. Compensation Overview: Madison - Giralda - NJ - US: $200,980 - $243,544 Princeton - NJ - US: $200,980 -
$243,544 The starting compensation range(s) for this role are listed above for a
full-time employee (FTE) basis. Additional incentive cash and stock
opportunities (based on eligibility) may be available. The starting pay rate
takes into account characteristics of the job, such as required skills, where
the job is performed, the employee’s work schedule, job-related knowledge, and
experience. Final, individual compensation will be decided based on demonstrated
experience. Eligibility for specific benefits listed on our careers site may vary based on
the job and location. For more on benefits, please visit
[ Benefit offerings are subject to the terms and conditions of the applicable
plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). * Financial Well-being and Protection: 401(k) plan, short- and long-term
disability, life insurance, accident insurance, supplemental health
insurance, business travel protection, personal liability protection,
identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off * US Exempt Employees: flexible time off (unlimited, with manager approval, 11
paid national holidays (not applicable to employees in Phoenix, AZ, Puerto
Rico or Rayzebio employees)* Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees:
160 hours annual paid vacation for new hires with manager approval, 11
national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited
paid sick time, up to 2 paid volunteer days per year, summer hours flexibility,
leaves of absence for medical, personal, parental, caregiver, bereavement, and
military needs and an annual Global Shutdown between Christmas and New Years
Day. All global employees full and part-time who are actively employed at and paid
directly by BMS at the end of the calendar year are eligible to take advantage
of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.)
office-based employees due to the unique nature of their work. Summer hours are
generally not available for field sales and manufacturing operations and may
also be limited for the capability centers. Employees in remote-by-design or
lab-based roles may be eligible for summer hours, depending on the nature of
their work, and should discuss eligibility with their manager. Employees covered
under a collective bargaining agreement should consult that document to
determine if they are eligible. Contractors, leased workers and other service
providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers
With 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 a supportive culture, promoting global participation 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 an 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. Supporting People with Disabilities 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
View email address on click.appcast.io [View email address on click.appcast.io]. Visit careers.bms.com/
to access our complete Equal Employment Opportunity statement. Candidate Rights 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:
[ Data Protection We will never request payments, financial information, or social security
numbers during our application or recruitment process. Learn more about
protecting yourself at
[ Any data processed in connection with role applications will be treated in
accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law
or incorrect in any way, please contact BMS at View email address on click.appcast.io
[View email address on click.appcast.io]. Please provide the Job Title and Requisition number so
we can review. Communications related to your application should not be sent to
this email and you will not receive a response. Inquiries related to the status
of your application should be directed to Chat with Ripley. R1601540 : Director, eCOA Management
Vacancy posted 8 hours ago
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