Associate Clinical Lead Director
Company: IQVIA
Location: Atlanta
Posted on: May 28, 2023
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Job Description:
PURPOSE
Clinical Leadership is focused on the delivery and quality of the
contracted Clinical services within a project to achieve customer
satisfaction. Focus is on leveraging clinical operations and
therapeutic expertise along with the diverse IQVIA solutions to
drive operational excellence particularly in respect to
subject/patient recruitment and on time high quality data
collection. The Clinical Lead provides leadership of the clinical
team, in support of the project leader, and in collaboration with
the other functional teams, to achieve the delivery of the
project's overall objectives to the Sponsor's satisfaction per
contract while optimizing speed, quality and cost of delivery and
in accordance with our SOPs, policies and practices.
RESPONSIBILITIES
Accountable for ensuring the "right subjects" and "right data" to
meet our contractual requirements.
May contribute to the development of the project delivery strategy
for Request for Proposals (RFPs).
Participate in bid defense preparations. Lead the Clinical delivery
strategy at bid defense presentations in partnership with Project
Leader Business Development for large, complex, multi-region
studies. Understand the overall project strategy and translate the
agreed upon clinical approach to a successful practical delivery
model.
Develop and maintain clinical project plans, including but not
limited to clinical operations plan, recruitment and retention
strategy plan, etc. to be incorporated into the integrated study
management plan/project management plan.
Accountable for the clinical delivery (subject recruitment, site
management, data integrity) per contract, ensuring consistent use
of study tools and training materials and compliance with standard
processes, policies and procedures.
Partner with the project leaders to confirm objectives of the
clinical team according to agreed-upon contract, strategy and
approach. Effectively communicate and assess performance against
these agreed objectives.
Ensure all appropriate subject/patient recruitment strategies are
in place at the outset of the study to maximize subject/patient
recruitment opportunities to achieve delivery according to
contract, including, but not limited to, all outreach or digital
offerings being explored and deployed.
Ensure all processes and tools are available to maximize clinical
team's ability to monitor and secure patient recruitment to the
monitoring team from the outset of the study including, but not
limited to a clear recruitment strategy plan, the subject/patient
pathway materials and clearly defined contingency plans with agreed
trigger points for deployment. Throughout the study these
strategies and materials should be kept under constant review and
updated in response to progress on the study to ensure clear
understanding by all parties (internal and external) of
expectations throughout the recruitment period; and inspire
customer confidence in a clear and enforced action plan and thereby
ensure successful delivery to customer satisfaction.
Monitor clinical progress against contract and prepare/present
project information proactively to all stakeholders internally and
externally as required.
Deliver the project/program according to the quality management
plan. Guide CRAs and advise on critical specific study issues.
Collaborate with other functional groups within the company where
necessary to support milestone achievement and to manage study
issues and obstacles.
Manage risks (positive and negative) which could impact on the
clinical delivery of the project and determine
contingencies. Partner with functional leaders in problem solving
and resolution efforts.
Achieve project quality by identifying quality risks and issues,
responding to issues which impact the clinical delivery, responding
to issues raised by project team members and planning/implementing
appropriate corrective and preventative action plans.
Serve as clinical project contact with customer where applicable
and agreed with the project leader.
Drive for high performance and efficiency of the clinical team to
support financial success of the project.
Support the project leader in ensuring the financial success of the
project.
Collaborate with the project leader in forecasting and identifying
opportunities to accelerate activities to bring
Site Management revenue forward. Ability to assess impact of
project events which will have impact on financial performance.
Identify changes in scope and support project leader in completion
of the change control process.
Identify and communicate lessons learned and implement best
practices to promote continuous improvement.
Participate in, champion and adopt function and/or corporate
initiatives, changes and/or special project assignments; act as a
client liaison, departmental cross-functional liaison and/or change
agent.
Provide input to line managers of their project team members'
performance relative to project tasks. Support staff development.
Mentor less experienced project team members on assigned projects
to support their professional development.
All responsibilities are essential job functions unless noted as
nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In depth knowledge of, and skill in applying applicable clinical
research regulatory requirements; i.e., Good Clinical Practice
(GCP) and International Conference on Harmonization (ICH)
guidelines
Broad protocol knowledge; therapeutic knowledge
Strong understanding of Clinical Research industry
(drug/device/technology/etc.) and the relevant environments in
which it operates
Good understanding of the competitive environment and how to
communicate/demonstrate value through IQVIA services &/or
solutions
Ability to understand customer needs and appropriately influence
decision making
Strong understanding of other company functions and their
inter-relationship to achieve project delivery
Good knowledge of Project management practices and terminology
Ability to develop and deliver training materials to achieve
clinical team understanding of project and enable effective
delivery thereof
Good understanding of project financials
Proven ability to work through others to deliver results to the
appropriate quality and timeline metrics, monitoring/managing
performance and providing feedback; experience productively
partnering cross functionally and with customers to advance work
effectively and efficiently
Ability to identify and organize clinical resources needed to
accomplish tasks, set objectives and provide clear direction to
others; experience planning activities in advance and taking
account of possible changing circumstances; manages time
effectively
Excellent communication and presentation skills, including good
command of English language
Demonstrated high proficiency in using systems and technology to
achieve work objectives
Proven ability at analyzing data and information to derive
conclusions and drive sound decision making
Experience working productively in a pressurized environment,
managing competing priorities and maintaining a positive outlook at
work; handles criticism well and learns from it
Excellent customer service skills and demonstrated ability to
understand customer needs and appropriately influence decision
making
Strong software and computer skills, including MS Office
applications
Demonstrated learning agility and openness to learning and keeping
own knowledge and skill set current and evolving
Effective mentoring and training skills, fostering learning and
knowledge sharing with colleagues
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
PHYSICAL REQUIREMENTS
Extensive use of telephone and face-to-face communication requiring
accurate perception of speech
Extensive use of keyboard requiring repetitive motion of
fingers
Regular sitting for extended periods of time
May require occasional travel
This is a remote / WFH opportunity
IQVIA is a leading global provider of advanced analytics,
technology solutions and clinical research services to the life
sciences industry. We believe in pushing the boundaries of human
science and data science to make the biggest impact possible - to
help our customers create a healthier world. Learn more at
https://jobs.iqvia.com
We are committed to providing equal employment opportunities for
all, including veterans and candidates with disabilities.
https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA's ability to
operate and provide certain services to customers and partners
necessitates IQVIA and its employees meet specific requirements
regarding vaccination status.
https://jobs.iqvia.com/covid-19-vaccine-status
IQVIA is a world leader in using data, technology, advanced
analytics, and expertise to help customers drive healthcare - and
human health - forward. Together with the companies we serve, we
are enabling a more modern, more effective and more efficient
healthcare system, and creating breakthrough solutions that
transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore
new possibilities. No matter your role, everyone at IQVIA,
including our colleagues at Q - Solutions, contributes to our
shared goal of improving human health. Thank you for your interest
in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Keywords: IQVIA, Atlanta , Associate Clinical Lead Director, Executive , Atlanta, Georgia
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