Jobs at Worldwide Clinical Trials

Lead statistical design, analysis and reporting for clinical trials. Develop and validate SAS programs, produce SDTM/ADaM datasets, tables/figures/listings, write SAPs and reports, advise on study design, ensure regulatory compliance, and manage statistics support for sponsor projects.

Manage and deliver site activation activities for clinical studies including site identification, document collection, EC/IRB coordination, contract monitoring, project planning, risk mitigation, metrics reporting, SOP contribution, and sponsor communication to meet GCP and regulatory requirements.

Manage planned and unplanned Quality Management Document deviations, maintain QMS trackers and electronic tools, deliver and support QMS training, analyze deviation trends and KPIs, and report findings to governance. Support external dissemination of QMS records and provide stakeholder and audit/inspection support as needed.

Conduct continual assessment of therapeutic markets, analyze trial and funding trends, build and maintain market and account-tiering models, support CRM and KPI tracking, create presentations for stakeholders, and collaborate with vendors and Sales Operations to forecast opportunities and measure market penetration.

Collect, process, evaluate and report serious adverse event (SAE) data per regulations and SOPs. Author Safety Management Plans, perform safety database data entry and QC, generate queries and regulatory safety reports, follow up with sites, and serve as Lead PV Associate on small to moderate studies.

Lead statistical support for clinical trials: design consultation, write and review SAPs, develop and validate SAS programs and CDISC datasets (SDTM/ADaM), produce tables/figures/listings, support reporting, QA, bids, and process improvements while ensuring regulatory compliance.

Support post-award site identification by developing strategies, managing feasibility questionnaires, coordinating CDAs and outreach, recommending sites, training and overseeing site activation resources, leading client discussions/escalations, and working with remote teams. Requires GCP knowledge, MS Office proficiency, a relevant degree, 5+ years' experience, and occasional travel (<10%).

Support post-award site identification by developing site identification strategies, managing feasibility questionnaires, coordinating CDAs and outreach, recommending sites, training and overseeing Site Activation Specialists, and supporting remote teams. Travel under 10%.

Lead and oversee site contracting for clinical studies across Europe: negotiate and finalize clinical trial agreements and budgets, act as SME for country/site contract processes, supervise and mentor site contracts specialists, maintain study contract documentation in SharePoint, and deliver departmental trainings while collaborating with legal, finance, data protection, and clinical teams.

The Project Manager coordinates clinical trials, manages project aspects like technical and financial details, ensuring deliverables meet expectations.