Senior Clinical Lead - Oncology

Senior Clinical Lead - Oncology

09 oct
|
Quintiles Transnational
|
Buenos Aires

09 oct

Quintiles Transnational

Buenos Aires

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
Quintiles 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.

 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 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.

 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

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