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 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 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 sponsor 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.
Identify changes in scope and support 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.
Ideal Background : Education :
Advanced degree or equivalent education / degree in life science / healthcare recommended.
7 years clinical research / monitoring experience; or equivalent combination of education, training and experience.
At least 2-3 years leading clinical research studies (regional and / or globally speaking) . Involvement in cross-functional, multicultural and international clinical trials;
demonstrated capabilities in supporting operational aspects of clinical trial related activities.
Skills & abilities :
Broad protocol knowledge.
Strong software and computer skills, including MS Office applications
Client Focus : excellent customer service skills and demonstrated ability to understand customer needs, have difficult conversations with internal / external stakeholders and with the customer, and negotiate solutions.
Strong communication skills.
Leading & Directing
Deciding and Initiating Action
Planning and Organizing
Coping with Pressure & Setback
Project Centric Delivery
Fluent English (oral and written). Mandatory.
Job dimensions :
Should be based on Buenos Aires, Argentina.
Individual Contributor role (no direct reports).