Jobs at Parexel

The Senior Clinical Research Associate is responsible for site management and monitoring of clinical trials, ensuring compliance with regulations and quality standards, and enhancing investigator site relationships.

Manages clinical laboratory sample operations for clinical trials, including collection, processing, storage, shipping, data transfer, compliance, vendor coordination, cost forecasting, timelines, and issue resolution. Partners with precision medicine, clinical, data management, logistics, laboratory, scientific, and CRO teams to ensure high-quality samples and data support biomarker and non-biomarker evaluation. Provides operational and project management support while ensuring protocol, informed consent, and human sample management compliance.

The APEX Clinical Research Associate program provides foundational clinical research training and hands-on experience supporting project activities, study initiation, and site-facing work. Participants use clinical systems, complete monitoring-related tasks, and accompany CRAs on observational and co-monitoring visits. Upon completion, they transition toward independent CRA responsibilities, including site relationship management, issue resolution, quality oversight, and study delivery. The role is field-based, requiring frequent travel to investigator sites and participation in required training.

Lead global regulatory labeling strategy and governance for pharmaceutical products across US, EU, and international markets. Responsibilities include managing core labeling documents, regulatory submissions, artwork, health authority negotiations, compliance reviews, committee leadership, change control, and lifecycle implementation. The role requires cross-functional collaboration, interpretation of clinical and scientific data, regulatory expertise, and proficiency with labeling, document management, and change management systems.

Conducts oncology clinical trial site management, monitoring, activation, routine visits, and close-out activities. Ensures compliance with protocols, ICH/GCP, FDA regulations, sponsor standards, and patient-safety requirements. Manages investigator relationships, recruitment, adverse-event follow-up, investigational product accountability, data queries, documentation, protocol deviations, and CAPA remediation. Partners with study teams, vendors, and site personnel, supports audits and inspections, and may mentor Clinical Research Associates.

Lead hands-on R and SQL programming for real-world evidence studies using claims and EHR sources (Flatiron, Optum). Clean/validate RWD in Snowflake, implement RWE protocols, apply epidemiologic and statistical methods, create documentation, dashboards, and reporting, and collaborate with study teams to meet timelines.

Lead multi-channel recruitment marketing campaigns to build talent pipelines and reduce time-to-hire. Create employer brand content, analyze ATS and recruitment data for insights and SEO, manage vendor relationships, coordinate hiring events, and collaborate with cross-functional teams to optimize the candidate journey.

The Regulatory Affairs Consultant guides clinical studies through regulatory requirements, advising teams on compliance and strategies for efficient trial execution. They engage with health authorities, manage communication, and ensure quality documentation.

Serve as a Clinical Pharmacology subject-matter expert advising biopharma sponsors on regulatory strategy, clinical pharmacology plans, dose selection, PK/PD and pediatric/special population strategies; lead client engagements and regulatory interactions; assess IND/CTA/NDA/BLA/MAA submissions; present at conferences, publish, mentor internally, and provide thought leadership across therapeutic areas.

Lead regulatory strategy across programs and portfolios, advise on authority engagement and submission strategies, coordinate high-impact regulatory submissions, develop lifecycle and long-range development plans, align regulatory approaches with clinical and commercial teams, and monitor regulatory landscape changes to inform development decisions.

Lead end-to-end planning, execution, and delivery of complex global oncology and inflammation clinical trials. Provide trial team leadership, oversee feasibility, vendor management, compliance (GCP/regulatory), recruitment and risk mitigation, data delivery, TMF archiving, and support reporting/publication activities while liaising with cross-functional and external stakeholders.

Manage the full lifecycle of purchase orders in SAP, reconcile POs, run spending and actuals reports, support invoice processing and accruals, liaise with scientists, Finance, and Procurement, address ARIBA queries, support audits and year-end PO maintenance, and maintain PO documentation.

Lead a global organization delivering investigator payment services across regions and portfolios. Set strategy, drive operational excellence, modernization (automation, analytics, AI), stakeholder engagement, and talent development to ensure timely, accurate, compliant site payments and scalable processes.

Lead planning, execution, and delivery of oncology/inflammation clinical trials. Oversee trial setup, conduct, vendor management, regulatory compliance, patient/site engagement, risk mitigation, data cleaning, TMF archiving, and cross-functional coordination to meet milestones and KPIs.

Provide end-to-end regulatory affairs support for partnered pharmaceutical programs, including document and archive management, clinical regulatory support (e.g., Form FDA 1572 waivers, GLP reviews), drafting administrative submission components, building electronic submission structures, authoring and reviewing regulatory submissions, and managing post-approval reporting and compliance. Serve as regulatory liaison in alliance and cross-functional meetings to track deliverables and ensure regulatory readiness.

The Senior Clinical Research Associate oversees site management and monitoring for clinical trials, ensuring compliance with GCP, patient safety, and quality execution of studies. Responsibilities include managing operational aspects, training site personnel, addressing protocol issues, and conducting monitoring activities.

Lead and manage FSP Data Management program(s), overseeing staff, resourcing, client relationships, KPIs, budgeting/billing, compliance, and continuous improvement to meet contractual deliverables and retain talent.

Lead global regulatory labeling strategy and governance for pharmaceuticals, managing core labeling documents (CDS, USPI, SmPC), committee leadership, regulatory submissions, health authority negotiations, advertising/artwork review, and cross-functional implementation to ensure compliant, high-quality labeling across international markets.

Lead development and execution of global regulatory plans, align cross-functional teams, manage GRST meetings, anticipate and mitigate risks, drive regulatory submissions (IND/BLA/MAA/eCTD), and deliver strategic reports and dashboards to senior stakeholders to support timely product registration and post-marketing activities.

Lead enterprise-wide AI adoption by translating technical AI concepts for non-technical stakeholders, curating education and communications, partnering with change management and L&D, triaging requests, and building a team to drive measurable AI adoption across the organization.