Associate Director, Trial Clinical Delivery Lead (all genders)

ppWork Your Magic with us! 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. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. /ppUnited 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. /ppbThe position requires to be on-site in Eysins for 3 days per week. /b /ph3Your role /h3ulliAccountable for the delivery and quality of site level activities in Phase I-IV Clinical Development studies; act as link between Clinical Site Leads (CSLs), Global functions CRO counterparts - single point of contact for site management operational topics/escalations; support information channeling and issue resolution for the study /liliProvide 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. /liliServe as the operational delivery expert for the study(ies) and promote data-driven, realistic planning at the site and study level. Drive delivery-focused accountability and ownership amongst key external (CRO/vendor partners) and internal partners as appropriate /liliFacilitate identification and implementation of operational excellence strategies within studies - leveraging expertise within Global Development Operations (GDO) and other partner functions. /liliEnsure 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. /liliPromote solution-orientated thinking and issue resolution at the country and study team level. Provide an escalation pathway to ensure study-specific major observations from CSLs are relayed to and followed up by the appropriate internal and/or external business partners. /liliSupport product and study-specific onboarding for new CDPC team members and contribute to enhancing their site/study management capabilities/skills. /liliPromote Product Knowledge ensuring all team members understand trial assets and protocols. Foster Collaboration: Encourage regular communication and teamwork between sites and stakeholders. /liliStreamline Information Sharing: Use clear channels to share updates and information. /liliDevelop Best Practices: Contribute to and follow guidelines for consistent site and study management. /liliLead regular calls with CSLs working on study and/or other activities within the assigned study(ies) /liliAct as functional lead for process improvement initiatives /li /ulh3As a Member Of The Clinical Trial Team /h3ulliRepresent the CSL group at the Clinical Operations Team (COT)/Clinical Trial Team (CTT) via: /liliRegular review meetings of study/site performance and quality metrics and the associated strategic action planning /liliAd hoc interactions to address immediate issues. /liliOther COT/CTT meetings as appropriate e.g., kick-off meeting /liliConsolidate and assess data-driven proposals for selecting countries and sites, ensuring quality and consistency across regions. Provide clear, actionable information to Clinical Trial Teams (CTTs) to support their decision-making and keep Clinical Site Leads (CSLs) informed of the final selection of regions, countries, and sites. /liliLead activities with internal and external stakeholders to proactively gather and integrate patient and physician insights into study design and conduct e.g., utilizing Patient and Site advisory boards, social media campaigns, surveys, interactions with patient advocacy groups/organizations etc. /liliDesign country start-up strategy in consultation with the Start-up Solutions Team and Country Start-up 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. /liliDesign 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: /liliLead identification and implementation of optimal solutions, considering program and study characteristics, with clearly delineated key performance indicators to deliver tangible impact and drive study execution e.g., utilizing digital channels, biomarker-driven recruitment services and Decentralized Clinical Trial (DCT) capabilities such as telemedicine, mobile health applications, wearable sensors, direct to patient medication, etc. /liliOversee service providers to ensure successful implementation within agreed timelines, budget, and quality. /liliDevelop and implement a monitoring strategy in collaboration with Clinical Trial Leads (CTLs) and Contract Research Organizations (CROs), using a risk-based quality management approach. Continuously update the strategy based on external changes and new internal data. /liliUtilize site performance and quality data analytics to drive proactive, risk-based site oversight practices and quality risk oversight and management across all stages of study delivery. /liliDevelop, implement, and follow up on robust Site Oversight Plans, in collaboration with the CTL(s) and working closely with the respective CSLs. /liliIdentify and encourage use of data-driven oversight tools and methods at the site and study level. /liliIdentify trends and issues within/across assigned study(ies) which may impact key study deliverables (e.g., timelines/quality/costs) and work with CSLs, CTLs, Data Managers, Clinical Lead(s) and other relevant business partners to implement action plans to resolve and/or mitigate. /liliParticipate in Investigator/Study Coordinator Meetings and promote information sharing with the CSLs as needed. /li /ulpTravel: Position may require domestic/international travel up to 20% of time. /ph3Who You Are /h3h3Minimum Requirements: /h3ulliBachelor's Degree Medical or Life Sciences degree in a clinical research related discipline /lili8-10 years professional and project management experience in delivering Clinical Operations of global clinical trials required. /liliExpert knowledge of clinical development (principles and concepts as well as regulatory environment e.g., ICH GCP and applicable regional/local regulations /li /ulh3Preferred Requirements /h3ulliOncology and/or Neurology and/or Immunology TA experience desired /liliExperience in clinical operations in a CRO, pharma or biotech company including site management/oversight, clinical study planning and conduct. /liliExhibit strong interpersonal skills: Adaptability / Flexibility, Critical Thinking, Strong Communication Skills, Analytical Skills, Business Partnering, Clinical Trials Knowledge, Influencing Skills, Strategic Thinking, Therapeutic Area Knowledge, and cultural awareness to effectively lead and collaborate with diverse teams. /liliAbility to work independently on assigned tasks or projects. /liliAptitude to interpret outputs from analytical tools to enhance and improve study execution. /liliAbility to assess risk, solve problems and take decisions. /liliDemonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way. /liliComfortable working in a fast-paced environment where speed is paramount. /li /ulh3What we offer: /h3pWe are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! /p /p #J-18808-Ljbffr