Senior Clinical Lead (All Therapeutic Areas)
Posted on: August 16, 2019
IQVIA--- is the leading human data science company focused on
helping healthcare clients find unparalleled insights and better
solutions for patients. Formed through the merger of IMS Health and
Quintiles, IQVIA offers a broad range of solutions that harness the
power of healthcare data, domain expertise, transformative
technology, and advanced analytics to drive healthcare forward.
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.
- Accountable for ensuring the "right subjects" and "right data"
to meet our contractual requirements.
- Participate in bid defense preparations. Attend bid defense
presentations and lead the clinical delivery strategy for medium
size and multiple country/region studies, in partnership with
business development and senior project leader as needed.
- 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 CRA's and advise on critical specific study
- 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
- 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
- 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
- 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.
- Adopt corporate initiatives and changes and serve as a change
advocate when necessary.
- 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.
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)
- Broad protocol knowledge; therapeutic knowledge
- Strong understanding of Clinical Research industry
(drug/device/technology/etc.) and the relevant environments in
which it operates
- Ability to understand customer needs and appropriately
influence decision making
- Good understanding of other company functions and their
inter-relationship to achieve project delivery
- Knowledge of Project management practices and terminology
- Ability to develop and deliver training materials to achieve
clinical team understanding of project and enable effective
- 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
- Excellent communication and presentation skills, including good
command of English language
- Demonstrated 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
- Strong software and computer skills, including MS Office
- 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
- Bachelor's degree in a health care or other scientific
discipline with 7 years clinical research/monitoring experience; or
equivalent combination of education, training and experience.
- Extensive use of telephone and face-to-face communication
requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of
- Regular sitting for extended periods of time
- May require occasional travel
Making a positive impact on human health takes insight, curiosity,
and intellectual courage. It takes brave minds, pushing the
boundaries to transform healthcare. Regardless of your role, you
will have the opportunity to play an important part in helping our
clients drive healthcare forward and ultimately improve outcomes
Forge a career with greater purpose, make an impact, and never stop
IQVIA is an EEO Employer - Minorities/Females/Protected
IQVIA, Inc. provides reasonable accommodations for applicants with
disabilities. Applicants who require reasonable accommodation to
submit an application for employment or otherwise participate in
the application process should contact IQVIA's Talent Acquisition
team at firstname.lastname@example.org to arrange for such an
Keywords: IQVIA, Durham , Senior Clinical Lead (All Therapeutic Areas), Healthcare , Durham, North Carolina
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