Jobs at Parexel

Lead and coordinate Clinical Trial Application (CTA) regulatory submissions in South Africa (and optionally other Southern African countries). Act as Local Regulatory Contact or Regulatory Lead, ensure timely, high-quality deliverables, participate in regulatory operations and project meetings, liaise with clients and agencies, and contribute to process optimization and cross-functional project planning.

Lead setup, execution and delivery of international clinical trials (oncology focus). Plan timelines, manage risk, oversee vendor services, ensure GCP/regulatory compliance, drive patient/site engagement, monitor recruitment and data cleanliness, and coordinate closeout, reporting and TMF archiving.

The Country Study Operations Manager will oversee study activities at the country level, including vendor and budget management, study recruitment strategies, and communication with stakeholders to ensure timely delivery of study plans.

Lead site-facing oversight of clinical trial monitoring effectiveness using ICH-GCP and risk-based approaches. Create oversight plans, perform site risk analyses, conduct sponsor oversight visits, support inspections, troubleshoot site issues, and collaborate with cross-functional teams and CROs to mitigate risk and improve site performance.

The Senior Clinical Research Associate manages site monitoring and close-out of clinical trials, ensuring quality and compliance with protocols and regulations while maintaining investigator relationships.

Lead end-to-end planning, execution and delivery of assigned global clinical trials. Provide trial team leadership, oversee feasibility, recruitment and risk mitigation, ensure GCP and regulatory compliance, manage vendor oversight, data delivery, safety reporting, TMF archiving, and support amendments, ethics responses, registries and publications as needed.

Manage execution of global clinical trial operations including CRO/vendor oversight, trial-specific document creation, recruitment planning, budgets and timelines, regulatory/GCP compliance, stakeholder liaison, inspection readiness, and training; support process improvement and team onboarding. Travel ~10%.

Lead global study start‑up and site activation for Phase I–III and real‑world trials. Develop and deliver start‑up plans with CROs, forecast enrollment, drive KPIs, remove site activation obstacles, implement process improvements, and mentor junior staff to ensure predictable, high‑quality study delivery.

Lead site activities for oncology clinical trials including site selection, initiation, monitoring (remote and onsite), data review/verification, drug accountability, regulatory submissions, safety reporting, CTMS/eTMF updates, risk-based monitoring, and preparing sites for audits/inspections while mentoring junior staff.

The Senior CRA manages site monitoring and relationships for clinical trials to ensure patient safety and compliance with GCP and standards, overseeing trial conduct, issue resolution, and training site personnel.

Lead data quality and data management for oncology clinical studies, overseeing DM teams, vendor/CRO oversight, risk management, data integration, standards compliance (CDISC/ICH-GCP), metrics reporting, resource and budget alignment, and stakeholder communications throughout study delivery.

Lead end-to-end planning, coordination, and delivery of Clinical Trial Applications (EU CTR and ROW). Manage timelines, documentation, risks, KPIs, and stakeholder relationships across global cross-functional teams, ensuring compliant, high-quality submissions and driving quality investigations as needed.

Support Global HRBP by analyzing HR data, identifying talent and retention opportunities, delivering HR programs and training, advising senior leaders, managing complex employee relations, and supporting regional HR projects and onboarding.

Drafts, reviews, negotiates, finalizes, and executes clinical site contracts and amendments. Ensures documents comply with laws and ICH-GCP, manages signatures and recordkeeping, liaises with sites and internal teams, tracks contract status, identifies risks, and implements process improvements while maintaining quality and timelines.

Lead in-country local study teams to deliver oncology clinical trial activities: site selection/start-up, monitoring, regulatory submissions, CTMS/eTMF management, budgeting/agreements, risk mitigation, audits, stakeholder coordination, and support patient recruitment and study documentation.

Lead and manage midsize to large Regulatory Affairs outsourcing programs as a trusted client advisor. Drive business development, prepare proposals, and deliver projects on time, on budget, and to quality standards. Provide cross-functional leadership, mentor project teams, monitor profitability and budgets, and resolve issues. Stay current with regulatory and industry trends to deliver innovative solutions and support global development and commercial programs.

Manage and mentor a team delivering clinical trial services, ensuring timely, high-quality project deliverables, resource planning, performance management, client liaison, and compliance with GCP/ICH and sponsor/Parexel SOPs.

Lead commercial pricing and site payment strategy across a global CRO portfolio. Oversee bid review and approval, develop rate cards and budgets, advise leadership on commercial packages, deliver market insights, and drive process improvements to increase bidding and contracting efficiency.

Lead country-level local study teams to deliver clinical study activities (site ID, qualification, initiation, monitoring, close-out), ensure regulatory submissions and trial documentation (eTMF, CTMS) are inspection-ready, manage budgets/agreements, support recruitment strategy, train/coaching team members, and liaise with global stakeholders. Requires oncology experience and oversight of compliance with ICH-GCP and local regulations.

Manage site selection, initiation, monitoring, and closure for clinical study sites. Ensure ICH-GCP and sponsor compliance, oversee drug accountability, data quality, safety reporting, CTMS/eTMF documentation, remote and on-site monitoring, risk-based monitoring, and support audits/inspections while collaborating with local study teams.