Associate Decentralized Clinical Trial Study Lead (aDCTL) / Decentralized Clinical Trial Lead (DCTL)

IQVIA; Oeiras; Presencial; EUR 60 000 - 90 000; Tempo integral

Resumo da oferta

IQVIA is seeking an Associate Decentralized Clinical Trial Study Lead (aDCTL) to drive delivery of DCT studies, from fully decentralized to hybrid setups, coordinating across technology, site support, regulatory and operations. You will own project performance, budget controls and communications with customers to ensure timely milestones and quality deliverables.

The role requires strong project management, stakeholder engagement and the ability to navigate complex regulatory requirements in a

Qualificações

• Bachelor's degree in Life sciences or related field.
• 4+ years of clinical research experience with about 3 years in project management.
• Experience with electronic Data Capture (eDC) - CRFs and/or Data Management.
• Advanced knowledge of project management methodologies in clinical research.
• Broad knowledge of decentralized clinical trials (DCT) and related areas.
• Knowledge of ICH GCP and local regulations for clinical trials.
• Technology savvy with ability to learn and adopt new platforms/systems.
• Strong written and verbal communication skills including presentations and customer management.

Responsabilidades

• Develop and deliver DCT studies in line with contracts, balancing speed, quality and cost.
• Serve as DCT project oversight contact with customers and own the client relationship.
• Set objectives and manage the DCT project team, communicating performance and providing leadership.
• Collaborate with core study teams to prepare management plans and address issues.
• Monitor progress and present project information to stakeholders.
• Oversee risk management, contingencies and issue resolution with proactive mitigation.
• Ensure project quality by identifying risks and implementing corrective actions.
• Oversee budget and resource allocation to achieve profitability.
• Identify scope changes and manage change control with customer agreement.
• Capture lessons learned and promote continuous improvement.

Conhecimentos

Project management

Stakeholder management

Communication

Leadership

Formação académica

Bachelor's Degree Life sciences or related field

Ferramentas

eDC (CRFs)

Data Management Systems

Descrição da oferta de emprego

The Associate Decentralized Clinical Trial Study Lead (aDCTL) / Decentralized Clinical Trial Lead (DCTL) are an integral part of clinical trial delivery to improve patients’ lives and bring therapies to the market faster. The aDCTL / DCTL roles requires strong project management skills, customer and site facing engagement experience, creativity/innovation and the ability to thrive in a dynamic setting.

The aDCTL / DCTL may oversee studies ranging from fully decentralized trials to hybrid studies which require liaising with traditional project delivery teams. Critical to the success of DCT is the ability to collaborate across multiple teams and stakeholders including but not limited to technology & IT , mobile nursing, site support services, regulatory, site startup, etc. aDCTL / DCTL’s also follow established SOP and policies focused on project delivery, productivity and quality resulting in strong project financial performance and customer satisfaction.

Essential Functions

• Accountable for the strategic development and delivery of DCT studies 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 DCT project oversight and/or contact with customers and own relationship with the project’s key customer contact(s)
• Set objectives and manage for the DCT project team according to agreed upon contract, strategy and approach for operational delivery, effectively communicate and assess performance, providing feedback and leadership.
• Collaborate with other functional groups within the company where necessary, including the core study team, to develop and/or support the preparation of integrated study management plans, support milestone achievement and manage study issues and obstacles.
• Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally.
• Supervise Foresee problem solving and resolution efforts to include management of risks, and manage contingencies and issues. Take accountability for proactive contingency plans to mitigate risks.
• 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.

Take ownership, understand the budget and drive optimal project financial management from initial load to study closeout

• Ensure the financial success of the project including optimal management and assignment of resources to achieve project goals and profitability.
• Actively work on preserving DCT scope and Forecast and identify opportunities to accelerate activities to bring milestones and revenue forward and implement appropriate actions to achieve.
• 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.

Other Functions May Include

• Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for 100% Virtual studies or as a component of the larger team for integrated hybrid DCTs studies. Understand project strategy and operationalize the agreed upon approach.
• 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.
• Educate and train other teams and partners on the processes, capabilities and structure of the DCT organization.
• Communicate/collaborate with IQVIA business development representatives as necessary.
• May participate in executive committees as part of program leadership.

Qualifications

• Bachelor's Degree Life sciences or related field
• Requires +4 years relevant clinical research experience plus around 3 years of experience in project management experience.
• Previous experience in electronic Data Capture - eDC (CRFs) and/or Data Management.
• Requires advanced knowledge of and experience implementing Project Management methodologies, ideally within the clinical research space.
• Broad knowledge of DCT (current challenges and opportunities to improve clinical trial delivery) and other related job areas, typically obtained through advanced education combined with experience.
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
• Technology Savvy – You have an affinity for learning and leveraging technology. Prior experience with set up or implementation of new platform/systems is a plus.
• Communication - Strong written and verbal communication skills including good command of English language. Strong presentation, negotiation and customer management skills.
• Finances - Good understanding of project financials including experience managing financials (budget), contractual obligations and implications.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.