Decentralized Trial Lead

IQVIA (Buenos Aires, Argentina) Publicado hace 11 días

Decentralized Trial Leads (DCTL) are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The DCTL is an essential member of the core project team, working as the functional lead for all DCT components, in order to meet contractual requirements in accordance with SOPs, policies and practices. Decentralized Trial leadership is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. DCTL focus is on leveraging therapeutic expertise and IQVIA’s DCT solutions to drive operational excellence and strategic leadership with our customers. The DCTL is a subject matter expert helping to guide project teams on the appropriate use of decentralized solutions.

Responsibilities

Essential Functions

  • Lead all functional areas of DCT, including Site Operations, DCT platform implementation, integrations with other DCT systems (i.e. eConsent, eCOA) and all other aspects of DCT

  • Work with study team to create and obtain required inputs for DCT platform design and ensure end-to-end tech integrations

  • Leads the DCT Site Operations strategy and oversight

  • Train both the DCT and Traditional teams on the processes, capabilities and structure of the DCT organization, capabilities and study-specific DCT offerings

  • Work with the study Project Leader (PL) to ensure all DCT documentation is created, integrated into study-wide documents and DCT is represented fully at the wider study team level

  • Accountable for the strategic development and delivery of DCT study components in line with agreed upon contracts, while optimizing speed, quality and cost of delivery, ensuring consistent use of study tools and training materials and compliance with system updates, standard processes, policies and procedures.

  • Serve as primary DCT leader with the customer and own the relationship with the project’s key customer contact(s) and stakeholders

  • Participate in bid defense preparations. Lead DCT bid defense presentations in partnership with Business Development. Understand project strategy and operationalize the agreed upon approach.

  • Set objectives for the DCT team according to agreed-upon contract, strategy and approach, effectively communicate and assess performance, providing feedback and leadership.

  • Collaborate with other functional groups within the company where necessary, including the traditional study team, to support milestone achievement and to manage study issues and obstacles.

  • Monitor DCT progress against contract and prepare/present project information proactively to all stakeholders internally and externally.

  • In collaboration with the study PL, coordinate all DCT problem solving and resolution efforts to include management of risk, contingencies and issues. Take accountability for proactive contingency plans to mitigate risks to DCT deliverables

  • Develops and manages integrated DCT timelines and reports weekly progress to internal and external stakeholders, including plans to address potential timing risks/gaps

  • Achieve project quality by identifying and proactively managing quality risks and issues, responding to issues raised by project team members and /implementing appropriate corrective and preventative action plans.

  • Reviews the project DCT budget with the project PL, finance lead, PVM and the DCT Business Unit Finance Lead, against project milestones to ensure project profitability. Takes corrective measures where necessary to keep project in line with budget and profit expectations

  • Forecast and identify opportunities to accelerate DCT activities to bring milestones and revenue forward and implement appropriate actions to achieve.

  • Work with the study PL to identify changes in scope and manage change control process, including securing customer agreement to financial and milestone updates as necessary.

  • Identify and communicate lessons learned and best practices to promote continuous improvement.

  • Adopt corporate initiatives and changes and serve as a change advocate when necessary.

  • Provide input to line managers on 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.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education

Bachelor's Degree Life sciences or related field.

Experience

Requires a minimum of 5 years CRO or industry experience and/or a minimum 3 years’ experience in a DCT environment or functional lead environment.

Experience/ Skills and Abilities

  • Experience in working with complex technology platforms in the healthcare industry
  • Understanding of DCT and the associated technology area
  • Knowledge and experience of clinical trial conduct in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
  • Broad protocol knowledge, and experience in understanding study specifications.
  • Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA DCT offerings.
  • Strong organizational skills with proven ability to handle multiple projects.
  • Strong written and verbal communication skills including good command of the English language. Requires strong negotiation and excellent customer service skills and demonstrated ability to understand customer needs.
  • Strong presentation skills.
  • Strong problem-solving skills.
  • Leadership - 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 make decisions, bringing clarity to disparate information to inform actions and drive results.
  • Ability to work strategically to realize project goals, identifying and developing positive and compelling visions for the successful delivery of the project.
  • Attention to detail and accuracy in work, along with a results-oriented approach to work delivery and output.
  • 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.
  • Good understanding of project financials including experience managing, contractual obligations and implications.

IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, Innovation and Ownership)

At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.


Decentralized Trial Lead

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