Sr. Mgr. Risk Based Quality Management - Adaptive Monitoring Excellence

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Sr. Mgr. Risk Based Quality Management - Adaptive Monitoring Excellence
Job ID
R0095747
Date posted
May. 09, 2023
Location
Boston, Massachusetts
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Job Description
Takeda
Takeda fosters a collaborative and stimulating work environment, filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases and vaccines. Boston (Massachusetts) is the
R&D (Research & Development)
headquarters.
Clinical Quality Management (CQM) at Takeda
Clinical Quality Management
is responsible for
implementing an enterprise-wide strategy for
Risk Based Quality Management (RBQM)
and
Adaptive Monitoring (AM)
to focus on critical-to-quality risks that drive data quality and site performance across the entire study lifecycle.
OBJECTIVE
S
As the Sr. Mgr. Risk Based Quality Management - Adaptive Monitoring Excellence, you will report to the
D
irector of
Adaptive Monitoring Excellence
and are
responsible for
successfully
developing
and
overseeing
RBQM
-appropriate monitoring strategies at
the study level,
driving the adoption of risk-based monitoring and data-driven monitoring solutions.
Responsibilities:
A
s
assigned to support
study execution team
s
responsible for the
implementation of
Adaptive Monitoring
procedur
es
I
nterpret
critical data, critical processes, and
key risk
s assigned for site monitoring mitigations
to
determine
study specific
site monitoring
requirements
Lead
adaptive monitoring
strategy
meetings, engaging cross-functional study team members to
identify
study-level
SDV and SDR
strategies, aligned with
Takeda’s
adaptive
monitoring schemas 
Ensure
risk-based
monitoring strategies are
integrated in
Takeda’s
IQRMP
and site
monitoring
functional
plan
s
and
ensures strategies are
correctly configured in
technology solutions
(TSDV, Veeva
CDMS, CTMS
etc
Partner with RBQM Operations team
to e
nsure
central monitoring findings and other signals
identified
for site monitoring mitigation are
effectively
communicate
d
and addressed by site
monitoring
teams
, documenting any need for
the
adjustment of
source data verification or
source data
review targets
Perform periodic assessment of the compliance with monitoring plans at the study, region, site, monitoring partner and personnel levels, and
identifies
and escalates issues and emerging monitoring compliance risks to the study execution team 
Leverage
identified
signals to c
oordinate
Monitoring Oversight Visit
activitie
s for selected studies, and ensures
appropriate
processing
of related visit reports and
findings
Maintain up-to-date,
accurate
documentation of
Adaptive Monitoring
activities 
Maintain
high quality, consistency, and
compliance with RBQM procedures
across studies
Recommend
adaptive monitoring
process
adjustments
based on feedback and data-driven
trends in overall RBQM success measures
Identify
and shares best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with
CQM’s
RBQM processes
Act
as a change agent, champion, subject matter expert and point of contact
for adaptive monitoring concepts
, leading study teams to understand and follow the best practices to achieve maximum benefit
Support and
participate
in internal and external audits and inspections as related to Takeda’s adoption of RBQM and Adaptive Monitoring 
EDUCATION, EXPERIENCE,
KNOWLEDGE,
AND SKILLS:
Education:
Bachelor’s
D
egree
in a health-related, life science area
o
r international equivalent preferred, or equivalent combination of education, training, and work experience
Experience: 
Minimum of
6
years' of experience in the pharmaceutical or
CRO
industry
Minimum of
2
years' of experience in Risk Based
Quality
M
anagement
, Risk-Based Monitoring,
or Adaptive Monitoring roles
Robust understanding of the drug development process and clinical trial execution
Knowledge of industry regulator
y
standards including 21
CFR
Part 11,
ICH
E6 (
GCP
Skills:
Experience in
site monitoring and
risk
-based monitoring
including
onsite
and remote
monitoring models
Experience in
establishing
risk-appropriate monitoring approaches, and
assessing site monitoring
compliance
and quality/effectiveness
Knowledge of RBQM IT
systems
, targeted
SDV/SDR tracking, and EDC systems
Demonstrated ability to effectively lead cross functional team meetings
Experience forming
cross-functional collaborations
; strong interpersonal skills
Supports a culture of continual improvement and innovation; promotes knowledge sharing
Ability to influence without authorit
y
Thinks creatively
; challenges the status quo
Behavioral Competencies:
Pragmatic and willing to drive and support change
Comfortable
with ambiguity
Excellent teamwork, organizational, interpersonal, and problem-solving skills
Assertive
and collaborative communication sty
le
C
ritical think
ing
and growth mindset
Embraces and
demonstrates
a diversity and inclusion mindset and role models these behaviors for the organization
Demonstrated strong matrix leadership and communication skills
TRAVEL REQUIREMENTS:
Requires
0
- 10 %
travel,
potentially
including overnight and international travel.
Additional Information:
This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.
Base Salary Range: $130,000 to $186,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Massachusetts - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time #LI-Remote
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Job Type
Full time
Job Level
Senior
Travel
Minimal
At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people to take charge of their futures. In an environment that fosters lifelong learning and a growth mindset, you’ll have the support you need to thrive — at work and beyond.
Oversee execution of studies
Provide subject matter expertise
Lead strategy development
Pressure test timelines and assumptions
Where You Fit In
Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to create therapies that make a lasting difference to millions of patients around the world.
In Clinical Operations, all of that history comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues across functional areas, you’ll play a key role in bringing our rich pipeline of innovative products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies with honesty, integrity and fairness at Takeda will shape your bright future.
In my life, I’ve noticed where there’s a lack of treatment options for certain populations, or where there’s mistrust of trials. In clinical research, I can work on important real-world challenges like efficacy in medications and health equity.
LaShell Robinson
Director, Diversity & Inclusion in Clinical Trials
One of the ways we’re going to change how people see clinical research is by being positive role models out in the community. That’s what I see when I look at Takeda and the way our people lead.
Karen Correa
Head, Global
Clinical Operations
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Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.
Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.
We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.
Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.
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