Jobs at Parexel

Analyze clinical and operational study data to support Data Surveillance: develop Data Surveillance Plans, configure monitoring technologies, review data against KRIs and Quality Tolerance Limits, document findings, escalate issues, support meetings and reporting, and collaborate with technology and project teams to drive corrective actions.

Manage and monitor assigned clinical trial sites from initiation through close-out. Ensure protocol adherence, site training, data quality, regulatory/document management, site performance, and patient safety. Conduct on-site and remote visits, generate reports, support audits/inspections, maintain CTMS/TMF/EDC records, and collaborate with project teams to meet study milestones.

Lead drafting, review, negotiation and execution of clinical site agreements ensuring compliance with laws, regulations and ICH-GCP. Manage contract lifecycle, track statuses, resolve issues, align terms with protocol/budget, mentor junior staff, and implement process improvements to meet study timelines and quality standards.

Perform due diligence screening and open-source investigations for employees, vendors, investigators and third parties; maintain screening records in compliance systems; generate Power BI reports; update third-party data in Oracle Financials; support stakeholder onboarding, investigator clearance, audits, and process improvements while ensuring regulatory compliance with anti-bribery, sanctions, and FDA debarment requirements.

Lead and perform site monitoring activities from activation through close-out, ensuring GCP compliance, patient safety, data quality, SAE handling, TMF and reporting. Serve as primary site contact, support recruitment and training, collaborate with study team, drive CAPA and audit responses, and provide oversight of investigational product and site performance.

Lead development of persuasive, differentiated proposals and contract language for CRO business development. Conduct market and therapeutic research, manage proposal timelines, collaborate with sales and contract specialists, maintain templates and case studies, mentor junior staff, and drive continuous improvement in proposal processes.

Lead site contracting strategy and execution for global clinical trials, manage sponsor relationships and negotiations, oversee site contracts teams, develop and assess investigator budgets, ensure alignment with protocol and study objectives while managing timelines, budgets, and risks.

Negotiate, finalize, and execute clinical trial site contracts and budgets, manage contract amendments, ensure document quality and ICH-GCP compliance, and maintain client and site relationships while supporting site activation and post-activation changes.

Prepare, amend and finalize contracts and project budgets from templates; negotiate and review client contractual documents; coordinate approvals; maintain contract databases; liaise with Finance, Legal, Project Management, Business Development and clients to ensure timely, compliant deliverables.

Lead statistical design and analysis for clinical trials, develop SAPs and protocols, support regulatory submissions, collaborate with cross-functional teams, drive trial design and interpretation, ensure data standards (CDISC) and quality of deliverables.

Lead global site start-up strategy and execution for clinical trials, manage CRO and cross-functional relationships, ensure regulatory and TMF compliance, track startup metrics and risks, support regulatory submissions, drive process improvements, and mentor/coordinate regional SSU teams to achieve timely site activation.

Lead feasibility assessments for proposed clinical studies by evaluating study concepts, generating data-driven country/site recommendations using RWE and feasibility tools, authoring feasibility reports, collaborating cross-functionally, implementing technologies and processes, and supporting team capability building and timelines.

Execute site start‑up activities: collect, review, track, and submit regulatory and investigator site documents; manage eTMF/TMF filings; coordinate with CROs, IRBs, vendors, and study teams to enable timely site activation and inspection readiness.

Manage and administer clinical trial site contracts: review and negotiate terms, coordinate with legal and clinical teams, track signatures and budgets, ensure regulatory compliance, maintain contract records and databases, and support site onboarding and payments.

Support project planning, scheduling, documentation, reporting, and financial tracking. Coordinate meetings, capture minutes and actions, maintain trackers and dashboards, monitor risks/issues, assist timesheet reviews and invoice processing, and manage project closeout and archival.

Lead regulatory submission project management for high-quality, on-time filings (PMDA and global), coordinate cross-functional teams and vendors, manage eCTD/EDMS documents and metadata, ensure compliance with regulatory guidelines, maintain templates and processes, and support submission activities including PMDA consultations and approvals.

The Senior Clinical Research Associate manages study sites, ensures protocol compliance, evaluates data integrity, and supports site staff, all while maintaining adherence to clinical regulations and timelines.

Manage and oversee a clinical operations team to ensure high-quality, on-time delivery of project deliverables. Responsible for resourcing, staff development, performance management, client liaison, project oversight, quality control, regulatory compliance (ICH/GCP), and supporting business development and continuous improvement activities.

Oversee clinical trials through effective communication, project initiation and execution, team management, compliance with guidelines, and quality assurance during studies.

The Investigator Contracts Lead focuses on negotiating and managing clinical trial agreements, ensuring compliance, and collaborating with various stakeholders to facilitate site contracting processes.