Associate Director, CRA Monitoring Oversight and Excellence
Company: Daiichi Sankyo, Inc.
Location: Atlanta
Posted on: April 17, 2024
Job Description:
Join a Legacy of Innovation 110 Years and Counting! -Daiichi
Sankyo Group is dedicated to the creation and supply of innovative
pharmaceutical therapies to improve standards of care and address
diversified, unmet medical needs of people globally by leveraging
our world-class science and technology. With more than 100 years of
scientific expertise and a presence in more than 20 countries,
Daiichi Sankyo and its 16,000 employees around the world draw upon
a rich legacy of innovation and a robust pipeline of promising new
medicines to help people. Under the Group's 2025 Vision to become a
"Global Pharma Innovator with Competitive Advantage in Oncology,"
Daiichi Sankyo is primarily focused on providing novel therapies in
oncology, as well as other research areas centered around rare
diseases and immune disorders.
Summary
The CRA Oversight Associate Director plays an integral role in the
strategic development, oversight, and execution of global
monitoring conduct across the DS portfolio. This position will
serve two key roles: 1) support subject matter expertise (SME) with
the CRO oversight leads and 2) contribute to and plan for future
growth of a CRA organization. This is a highly collaborative and
dynamic role within a fast paced and results-oriented environment.
This role will embody principles of Quality by Design (QbD) as it
directly relates to risk-based monitoring (RBM) and Central
Monitoring.Responsibilities
CRA Oversight and SME:
- Develop and implement a monitoring oversight strategy to ensure
quality and compliance across the organization with applicable
policies and procedures as outlined in study-specific monitoring
plans.
- Oversee the development and ensure the execution of monitoring
activities that are outlined in the various study/CRO plans across
portfolios.
- Ensure CRO CRAs have quality oversight plans in place with
detailed escalation pathways.
- Ensure a strategic and manageable site engagement strategy is
in place in accordance with the RSEM and local country teams.
- Partner with TMF lead and CRO Oversight leaders to ensure CRAs
are updating appropriate systems.
- Ability to analyzes data/metrics/key performance indicators to
support vendor/CRO oversight of CRAs in clinical trials.
- Provide direction to Alliance and CRO CRA leadership on major
study commitments including resolving any key issues
identified.
- Ensure the CRO is overseeing CRA study activities at study and
country level and complying with local policies and code of
ethics.
- Collaborate on the development of monitoring plan templates
including review and annotation of monitoring-related
documentation.
- Review or ensure a model is in place for review of monitoring
visit reports of direct reports.
- Collaborate, execute, implement, and provide oversight on the
agreed RBM strategy and ensure the strategy is in place for every
study for CRAs to execute against.
- Identify trends and escalate significant issues and findings in
a timely manner.
- Support monitoring process checks linked with CRA activities
that require inclusion in the quality plan.
- Lead, participate, or support internal audit and regulatory
inspection activities related to site monitoring and sponsor
oversight.
- Contribute to the quality improvement of the study processes
and other procedures and ensure sites are inspection ready.
- Responsible for maintaining high level of visibility of
operational topics among leadership and stakeholders.
- Contribute to SOP updates.
- Strategize Future CRA Organization
- Based on resource decisions and approaches, support the set-up,
management, processing, and troubleshooting of FTE or a Functional
Service Provider (FSP) to source CRAs. This may include issue
escalation or resolution regarding resourcing or program delivery.
Partner with each study team and program leads to establish
appropriate CRA resourcing, deployment, coordination, training, and
prioritization. Manage resource strategies and capacity management
in accordance with budgetary requirements and emerging priorities
to ensure studies are delivered as planned and critical study
timelines are achieved. Ensure equitable and fair workload balance
for CRAs. Support successful delivery to plan, with speed and
quality.
People Management:
- At the time of hire this role will not have direct reports, but
there is a likelihood to develop a team of CRAs. If/when the roles
assume direct reports, it will be expected this leader:
- Coach the direct reports on a regular basis, and plan/organize
coaching with external providers if needed.
- Ensure capability build, individual development, and
performance management.
- Accountable for resource and capacity management within
respective portfolio and collaborating with peers to optimize
talent in the organization.
- Ensure the GPT GCO reps are functioning at a high and
consistent level. Coordinate training and onboarding of new CRAs.
Drive a feedback-oriented culture.
Qualifications: Successful candidates will be able to meet the
qualifications below with or without a reasonable
accommodation.Education Qualifications: (from an accredited college
or university)
- Bachelor's Degree required.
- Master's Degree preferred.
- Experience Qualifications
- BS in related discipline, or equivalent work experience
required.
- 8+ years' experience in clinical operations CRA capacity
required.
- 5+ years' experience in proven global line management
expertise; experience of performance management and development of
Manager level staff. required
- Relevant therapeutic experience and proven ability to learn new
indications. required
- Proven experience in Project Management leading and
implementing improvement initiatives, novel technology or
techniques in the context of clinical development. required
- Proven change management experience required.
- Proven strategic and innovative thinking required.
- Functional management experience, managing resourcing and
budget planning/oversight required.
- Ability to collaborate and establish a well-connected network
with other Early/Late Leaders and Clinical Operations Leadership
required.
- Demonstrated ability in influencing others in a matrix
environment required.
- Awareness of external competitive environment and operational
practices required.
- Demonstrated ability to set and manage priorities, resources,
performance targets and project initiatives in a global environment
required.
- Excellent written and verbal communication skills
required.
- Willingness to travel both domestic and international
required.
- Proven ability to develop successful collaborations with
internal and external partners required.
- Maintains high standards, including a commitment to Daiichi
Sankyo values, policies and employment principles required.
Travel:
- Ability to travel up to 20%.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action
employer. Qualified applicants will receive consideration for
employment without regard to sex, gender identity, sexual
orientation, race, color, religion, national origin, disability,
protected veteran status, age, or any other characteristic
protected by law.
Keywords: Daiichi Sankyo, Inc., East Point , Associate Director, CRA Monitoring Oversight and Excellence, Executive , Atlanta, Georgia
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