Die Stelle
0301Accountable for the delivery and quality of site level activities in Phase I-IV Clinical Development studies;
02act as link between Clinical Site Leads (CSLs), Global functions & CRO counterparts - single point of contact for site management & operational topics/escalations;
03support information channeling and issue resolution for the study
04Provide 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.
05Serve as the operational delivery expert for the study(ies) and promote data-driven, realistic planning at the site and study level.
06Drive delivery-focused accountability and ownership amongst key external (CRO/vendor partners) and internal partners as appropriate
07Facilitate identification and implementation of operational excellence strategies within studies - leveraging expertise within Global Development Operations (GDO) and other partner functions.
08Ensure 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.
09Promote solution-orientated thinking and issue resolution at the country and study team level.
10Provide 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.
11Support product and study-specific onboarding for new CDPC team members and contribute to enhancing their site/study management capabilities/skills.
12Promote Product Knowledge ensuring all team members understand trial assets and protocols.
13Foster Collaboration: Encourage regular communication and teamwork between sites and stakeholders.
14Streamline Information Sharing: Use clear channels to share updates and information.
15Develop Best Practices: Contribute to and follow guidelines for consistent site and study management.
16Lead regular calls with CSLs working on study and/or other activities within the assigned study(ies)
17Act as functional lead for process improvement initiatives
18As 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
19Ad hoc interactions to address immediate issues.
20Other COT/CTT meetings as appropriate e.g., kick-off meeting
21Consolidate and assess data-driven proposals for selecting countries and sites, ensuring quality and consistency across regions.
22Provide 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.
23Lead 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.
24Design 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).
25Work closely with the CSL to oversee and ensure delivery at the site and country level.
