Design and develop systems and data integrations using MuleSoft, building APIs, testing business logic, and improving existing architectures while engaging in Agile practices.

Support clinical/scientific conduct of studies including medical monitoring, adjudication support, imaging reconciliation, protocol deviation management, and stakeholder liaison. Prepare meeting materials and ensure compliance with GCP and company processes.

The Principal RWD Strategy Lead develops and implements RWD strategy for client projects, manages data relationships, and mentors junior team members. The role requires strong analytical skills and experience in clinical research, complying with regulations.

Support bioanalytical drug development by validating and operating LC-MS for sample analysis, ensuring GLP compliance, communicating results to team and investigators, and performing wet-lab tasks safely.

Conduct screening and protocol-specific participant visits, recruit and enroll study participants, maintain tracking systems and study logs, assist physicians with assessments, manage study supplies and samples, support monitoring visits, ensure participant safety and documentation accuracy, and comply with quality management and clinical operating guidelines.

Support development of Medical Services budgets for proposals and contracts by reviewing study documentation, preparing cost estimates, maintaining business tools, and collaborating with internal stakeholders to ensure accurate, timely budget delivery and compliance with company processes.

Lead development and oversight of complex Medical Services budgets for proposals and contracts. Analyze study documentation to produce accurate cost estimates, serve as primary contact for stakeholders, mentor junior staff, and maintain business tools and processes to improve efficiency and compliance.

Lead global site activation strategy and execution for assigned clinical trials, manage CRO and cross-functional partners, ensure compliant TMF documentation, support regulatory submissions, track metrics and risks, and drive process improvements to meet study start-up timelines.

As a Senior Regulatory Affairs Associate, you will manage regulatory processes, ensure compliance, and support product launches by collaborating with cross-functional teams and local health authorities.

The Senior Statistical Programmer manages clinical trial data programming, ensures quality control, develops programming strategies, and leads programming projects with minimal supervision.

The Sr. Clinical Research Associate manages sites for clinical trials, ensuring compliance with protocols and regulations, conducting monitoring visits, and collaborating with study teams.

The Senior Statistical Programmer conducts programming for clinical trials, supports project teams with analysis strategies, and ensures high-quality deliverables through programming standards compliance.

No specific responsibilities were provided in the posted job description.

Lead global study start-up and site activation for Phase I-III and real-world studies, oversee CRO delivery, develop startup plans, track KPIs, ensure regulatory compliance, drive process improvements, and remove activation roadblocks to ensure timely, high-quality study initiation.

The Clinical Laboratory Study Manager manages clinical trial sample operations, ensures compliance, oversees data management, and liaises with various stakeholders to support biomarker evaluation.

Lead global study start-up and site activation for Phase I-III and real-world trials. Develop global start-up plans, partner with CROs and stakeholders, forecast enrollment, track KPIs, remove activation barriers, and mentor junior staff to ensure timely, high-quality study delivery.

Lead investigations of major/critical quality events, perform root cause analysis, manage CAPA and audit/inspection coordination, mentor Issue Leads, drive process improvements and ensure regulatory compliance for clinical trial quality.

Build and maintain data pipelines and dashboards for clinical operational oversight. Clean and consolidate data using Python, implement anomaly detection and API integrations, automate validation checks, perform ad-hoc analyses, document tools, and lead AI/ML pilot projects while providing SME support and stakeholder training in local language and English.

Lead global clinical and laboratory supply chain for trials, ensuring GxP compliance, managing timelines, budgets, vendors, risks, regulatory interactions, and continuous process improvements.

Prepare and author regulatory and clinical trial documentation (INDs, NDA/BLA, briefing books, pediatric plans, orphan/fast track/breakthrough submissions). Provide regulatory consulting and project management across all drug development phases, interpret regulatory feedback, advise teams, and support 505(b)(2) pathway submissions while identifying scope changes and business opportunities.