Sr. Global Trial Manager (Remote)
Company: Bristol Myers Squibb
Posted on: September 22, 2022
At Bristol Myers Squibb, we are inspired by a single vision
transforming patients lives through science. In oncology,
hematology, immunology and cardiovascular disease and one of the
most diverse and promising pipelines in the industry each of our
passionate colleagues contribute to innovations that drive
meaningful change. We bring a human touch to every treatment we
pioneer. Join us and make a difference.Functional Area
Description:Global Trial Managers, crossing all therapeutic areas
and research phases, collaborate with cross-functional teams to
drive operational aspects of complex, global clinical research
studies from concept to final clinical study report.Position
Summary / Objective:
- Provides strategic and operational leadership of clinical
research studies to ensure delivery on time, within budget, and of
high quality in compliance with ICH/GCP, Regulatory Authorities'
regulations/guidelines, and applicable SOPs/WPs.
- Independently leads complex, large, global in-house or
outsourced, NonRegistrational Data Generating or Registrational
Data Generating trials/studies at any point in the life cycle of
the trial/study (i.e. start up, maintenance, or close-out).
- Acts as the primary operational contact for the study and leads
the crossfunctional global team for execution of the study.
- May provide operational leadership of one or more
cross-functional Study Team(s) and/or performance and quality
oversight of one or more Contract Research Organization (CRO) teams
- Has high global organizational impact and influence, and
significant impact on function and Study Team.Disclaimer: The
responsibilities listed above are only a summary and other
responsibilities will be requirements as assigned.Position
Responsibilities:Responsibilities involve a combination of
execution and oversight, dependent on the sourcing model, to ensure
deliverables and may include, but are not limited to, the
- Directs and delegates to the assigned Global Trial Management
Staff as applicable
- Drives study execution utilizing available performance metrics
and quality indicators and study milestones and drivers
- Oversees clinical monitoring quality and adherence to
established processes and plans.
- Develops, manages, and maintains study deliverables (i.e.
timelines, study plans, etc.) through collaboration with internal
and external stakeholders using data and strong interpersonal
influencing skills to make robust data driven decisions.
- Proactively identifies potential risks and develops/implements
actions to avoid/mitigate and make the appropriate trade-offs of
balancing risks with study deliverables and costs.
- Maintains/updates data as appropriate in project management
tools including CTMS.
- Troubleshoots complex issues with little guidance and
- Informs operational program lead(s) and other leadership (as
appropriate) on overall clinical trial plans, recruitment status,
and raises potential issues/mitigation.
- Leads, develops, and implements cross-functional/global
initiatives and best practices.
- Creates, maintains, and implements project management tools at
the study level (e.g. actions, decisions, issues log and risk
management plan).Study Planning and Conduct:
- Supports and oversees country and site feasibility/selection
processes with use of robust data.
- Provides operational and strategic input into Study Team and
- Collaborates with CSO on global investigational product [IP]
- Participates in the subject recruitment/retention strategy and
related initiatives (e.g. recruitment material).
- Participates in clinical service provider (vendor) selection,
specification development, and management/oversight.
- Oversees TMF set-up, ongoing quality review, operational
oversight memo, and requests final reconciliation.
- Provides input to and reviews study training for Study Team,
investigational sites, and vendors in collaboration with the
- Oversees study specific CSR appendices.
- Provides input and communicates with the appropriate teams for
response to country/regulatory and IRB/IEC.
- Proactively manages issues and information sharing with key
internal/external stakeholders with use of standardized reports and
- Highly proactive risk identification, contingency planning,
innovative problem solving, and the ability to solve multiple
problems with varying degrees of complexity for multiple functions
and understands when escalation is needed.
- Oversees service providers without supervision.
- Leads Audit Response Team and CAPA and participates in
- Supports the development/management/review vendor scope of work
(SOW), invoices, and accruals as per the contract, quality
requirements, and budget.Relationship Management:
- Proactively develops and maintains collaborative relationships
with internal partners/stakeholders across the multidisciplinary
- Manages external partners including Contract Research
Organizations (CROs), Academic Research Organizations (AROs), and
other clinical service providers as applicable.
- Influences key stakeholders inside/outside of the team and
capitalizes on established relationships.Leadership Competencies:
- Creates realistic plans that clearly define goals, milestones,
responsibilities and results.
- Maintains focus on strategic objectives while accomplishing
- Places a priority on getting results with an emphasis on high
- Holds self and others accountable for accomplishing goals.
- Makes timely, data-driven decisions while balancing against
- Develops and maintains effective working relationships with
people across cultures.
- Encourages collaboration across teams, functions, and
- Ensures that conflict is handled constructively so that
performance is not impacted.
- Displays a willingness to challenge the status quo and take
- Responds resourcefully to changing business demands and
opportunities, proactively looking for ways the team can
- Maintains optimism, support and composure in times of change,
uncertainty, or stress.
- Executes/delivers on corporate objectives and drives
- Leads global cross functional therapeutic programs.
- Creates global solutions for processes.
- Acts as mentor, driver, and motivator to Global Trial
Specialist, Associate GTMs, GTMs, and others in the Study Team and
function, especially during challenging times.
- Frequently encourages others to consider new approaches and
ideas, avoiding getting stuck in a "one right way" approach.
- Models and promotes positive team behaviors in a
cross-functional setting by inspiring and holding others
accountable for accomplishing goals, building a culture of energy
and commitment that challenges people to excel, recognizing and
rewarding accomplishments, managing issues, and providing
guidance/feedback on performance.
- Can be viewed as a SME by cross functional teams.
- May participate in company initiatives, leads continuous
improvement initiatives, and shares knowledge where
- Provides guidance regarding company policies and
- BA/BS or equivalent degree in relevant discipline
- Minimum 6 years of clinical study management experience of
which at least 2 years should have been in direct multinational
- Experience in leading global clinical trials and
- Demonstrated project management and organizational skills with
strong presentation and communication abilities.
- Experience with electronic quality, compliance and CTMS
- Risk management experience preferred.
- Experience in managing CROs experience is a plus.Key Competency
- Demonstrated project management and organizational skills with
strong presentation and communication abilities.
- Ability to see and understand how work at hand may have program
or global implications and follows through to connect appropriate
- Strategic clinical trial project management and study
- Intermediate knowledge of clinical trial forecasting, and
- Expert knowledge of ICH/GCP, regulatory guidelines/directives,
and drug development and Clinical Trial Process (CTP).
- Expert level cross functional awareness.
- Proven success in using oral/written communication skills to
influence, inform, or guide others.
- Fosters a continuous learning mindset.
- Computer skills - Microsoft applications including (but not
limited to), Word, Excel, PowerPoint.
- Proficiency in study tools including electronic system skills
e.g. CTMS / eTMFManagement Competencies:
- Leadership/influence and negotiating management skills.
- Ability to effectively lead a cross-functional team in a matrix
- Time management skills - ability to effectively multi-task and
set priorities for self and assists others with the same.
- Has the command of the projects, the ability to zoom in and out
as the situation demands and deliver high quality presentations to
senior and executive leadership within and outside of BMS (as
- Has critical thinking skills for problem solving and the
lateral and strategic thinking capacity to drive the study(ies) and
understanding the upstream, downstream and lateral implications of
decisions that affect study outcomes and timelines.
- Proven problem-solving skills to address and overcome complex
safety and compliance related issues during clinical program
implementation and execution.
- Excellent negotiating and influencing skills.
- Adaptable and flexiblewilling/able to adjust to multiple
demands and shifting priorities and demonstrates ability to meet
day-to-day challenges with confidence and professionalism.Travel
Required:Up to 25%Around the world, we are passionate about making
an impact on the lives of patients with serious diseases. Empowered
to apply our individual talents and diverse perspectives in an
inclusive culture, our shared values of passion, innovation,
urgency, accountability, inclusion and integrity bring out the
highest potential of each of our colleagues.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.Physical presence at the BMS worksite or physical presence in
the field is an essential job function of this role which the
Company deems critical to collaboration, innovation, productivity,
employee well-being and engagement, and enhances the Company
culture.To protect the safety of our workforce, customers, patients
and communities, the policy of the Company requires all employees
and workers in the U.S. and Puerto Rico to be fully vaccinated
against COVID-19, unless they have received an exception based on
an approved request for a medical or religious reasonable
accommodation. Therefore, all BMS applicants seeking a role located
in the U.S. and Puerto Rico must confirm that they have already
received or are willing to receive the full COVID-19 vaccination by
their start date as a qualification of the role and condition of
employment. This requirement is subject to state and local law
restrictions and may not be applicable to employees working in
certain jurisdictions such as Montana. This requirement is also
subject to discussions with collective bargaining representatives
in the U.S.Our company is committed to ensuring that people with
disabilities can excel through a transparent recruitment process,
reasonable workplace adjustments and ongoing support in their
roles. Applicants can request an approval of accommodation prior to
accepting a job offer. If you require reasonable accommodation in
completing this application or if you are applying to a role based
in the U.S. or Puerto Rico and you believe that you are unable to
receive a COVID-19 vaccine due to a medical condition or sincerely
held religious belief, during or any part of the recruitment
process, please direct your inquiries to firstname.lastname@example.org
. Visit careers.bms.com/eeo-accessibility to access our complete
Equal Employment Opportunity statement.Any data processed in
connection with role applications will be treated in accordance
with applicable data privacy policies and regulations.Company:
Bristol Myers SquibbReq Number: R1558210Updated: 2022-09-14
01:26:56.353 UTCLocation: Field,New JerseyBristol Myers Squibb is
an equal opportunity employer. Qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, age, disability, protected veteran status, pregnancy,
citizenship, marital status, gender expression, genetic
information, political affiliation, or any other characteristic
protected by law.
Keywords: Bristol Myers Squibb, Trenton , Sr. Global Trial Manager (Remote), Executive , Trenton, New Jersey
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