Associate Director, Trial Clinical Delivery Lead
vor 1 Woche
Ready to explore, break barriers, and discover more? We know you've got big plans '" so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.
Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life.
Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your role
- Accountable for the delivery and quality of site level activities in Phase I-IIIb Clinical Development studies; act as link between CSLs, Global functions & CRO counterparts single point of contact for site management & operational topics/escalations; support information channelling and issue resolution for the study
- Provide leadership, strategic direction and operational oversight for Clinical Site Lead (CSL) activities across assigned study(ies) in response to quality and performance oversight measures and trends
- Serve as the operational delivery expert for the study(ies) and promote datadriven, realistic planning at the site and study level. Drive deliveryfocussed accountability and ownership amongst key external (CRO/vendor partners) and internal partners as appropriate
- Facilitate identification and implementation of operational excellence strategies within studies leveraging expertise within Global Development Operations (GDO) and other partner functions
- Ensure timely and appropriate escalation of trends, issues and risks within the Clinical Operations Team/Clinical Trial Team/CRO/Vendor Team, department Leadership Team and/or Senior Management as appropriate
- Promote solutionorientated thinking and issue resolution at the country and study team level. Provide an escalation pathway to ensure studyspecific major observations from CSLs are relayed to and followed up by the appropriate internal and/or external business partners
- Support product and studyspecific onboarding for new CDPC team members and contribute to enhancing their site/study management capabilities/skills
- Promote product knowledge, collaboration and information channelling; contribute to best practice guidance to drive consistency in the management of sites/studies
- Lead regular calls with CSLs working on study and/or other activities within the assigned study(ies)
- Act as functional lead for process improvement initiatives
As a member of the Clinical Trial Team:
- Represent the CSL group at the Clinical Operations Team (COT)/Clinical Trial Team (CTT) via:
- Regular review meetings of study/site performance and quality metrics and the associated strategic action planning
- Ad hoc interactions to address immediate issues
- Other COT/CTT meetings as appropriate e.g. kickoff meeting
- Consolidate datadriven, CSL assessment of country and site selection proposals, ensuring quality and consistency across regions and countries to support CTT decision making; inform CSLs of resulting choices of regions/countries/sites
- Lead activities with internal and external stakeholders to proactively gather and integrate patient and physician insights into study design and conduct e.g. utilising Patient and Site advisory boards, social media campaigns, surveys, interactions with patient advocacy groups/organisations etc
- Design country startup strategy in consultation with the Startup Solutions Team and Country Startup Specialists (CSS), and in alignment with the CTL(s) and CRO(s). Work closely with the CSL to oversee and ensure delivery at the site and country level
- Design patient and site centric recruitment and retention strategies, in consultation with the CTL and CRO/Vendor(s), and in alignment with the study and company diversity and inclusion objectives:
- Oversee service providers to ensure successful implementation within agreed timelines, budget, and quality
- Establish monitoring strategy, including management of identified risks, in collaboration with the CTL(s) and CRO(s) and incorporating principles of a riskbased quality management approach. Ensure monitoring strategy is updated in response to changes of external environment and/or availability of internal data
- Utilise site performance and quality data analytics to drive proactive, riskbased site oversight practices and quality risk oversight and management across all stages of
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