Clinical Monitoring Lead overseeing CRO activities for clinical trials at Excelya. Coordinating efforts across study phases while ensuring compliance and quality standards in a hybrid work environment.
About the role
- Project Lead at IQVIA executing clinical studies to enhance drug delivery. Collaborating with cross-functional teams to ensure quality and compliance.
Responsibilities
- Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
- May be responsible for delivery and management of smaller, less complex, regional studies.
- Develop integrated study management plans with the core project team.
- Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
- Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
- Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
- Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.
- Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
- Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
- May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.;
- Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
- Ensure the financial success of the project.
- Forecast and identify opportunities to accelerate activities to bring revenue forward.
- Identify changes in scope and manage change control process as necessary.
- Identify lessons learned and implement best practices.
- May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.;
- 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 and mentor less experienced project team members on assigned projects to support their professional development.
Requirements
- Bachelor's Degree Life sciences or related field
- 5 years of prior CRO relevant experience including > 1 years project management experience or equivalent combination of education, training and experience.
- Advanced knowledge of job area, and broad knowledge of 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.
Benefits
- None specified
Job title
Job type
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Degree requirement
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