Jobs at Parexel

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.

Perform and troubleshoot automation and robotic workflows for high-throughput small-molecule reaction screening and solid-dispensing. Maintain and stock the laboratory, manage waste, assist development and implementation of automation platforms (Tecan, Unchained Labs, Technobis, Mettler Toledo Quantos, Trajan Chronect), and support sample analysis using HPLC/UHPLC/MS. Collaborate with team members and contribute to continuous improvement.

Lead the risk management process for clinical projects, ensure compliance with regulatory standards, mentor teams, and maintain audit readiness.

This role involves leading CMC regulatory strategies for global product lifecycle activities, authoring documentation, and managing submissions across international markets.

The Senior Clinical Research Associate will manage the operational aspects of clinical trials, ensuring compliance with regulations and monitoring sites to ensure patient safety and quality of studies.

Lead and manage clinical development projects for pharmaceutical clients end-to-end, ensuring regulatory and GCP/SOP compliance. Plan and coordinate cross-functional teams, control timelines, costs, and resources, engage clients to maintain satisfaction and profitability, and support communication via phone and Teams.

Provide legal support for commercial operations by drafting and negotiating customer and revenue-generating agreements, advising business units on legal risks, driving contract negotiations, meeting timelines, and collaborating cross-functionally to improve processes and guidelines.

Provide project-level support to Project Lead and team across project phases. Set up project tools per SOPs, produce reports and analyses, highlight issues, and collate monthly project financial metrics.

Lead country-level study operations from startup through close for one or more clinical trials. Oversee local study teams and CROs, manage country plans (timelines, budget, risk, quality), drive site activation and recruitment strategies, coordinate regulatory/ethics submissions, resolve site escalations, and ensure vendor deliverables and quality event follow-up.

Provide direct clinical care and safety monitoring for early-phase clinical trial participants, including drug administration, specimen collection, data entry, and adherence to SOPs and GCP. Support participant enrollment, perform assessments, report adverse events, and maintain clinical study files. Act as participant advocate and assist physicians with procedures and documentation.

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.

Lead global clinical trial operations end-to-end: vendor and pCRO oversight, study start-up, monitoring, budgets, risk mitigation, inspection readiness, and delivery of study-level plans and metrics. Mentor study staff, ensure compliance with GCP and SOPs, and coordinate cross-functional teams to achieve recruitment and data quality targets.

Support the full recruitment lifecycle: candidate communications, interview scheduling, background/reference checks, onboarding tasks, ATS (Workday) management, job posting, and recruitment reporting to improve hiring outcomes and candidate experience.

Monitor clinical trial sites through on-site and remote visits, manage site documentation and visit reports, build relationships with investigators and site staff, collaborate with cross-functional teams, implement corrective actions, and ensure sites remain audit- and inspection-ready.

Lead development of client-winning proposals and contracts for clinical research. Conduct market and therapeutic research, craft strategic content, manage proposal timelines, maintain templates, mentor junior staff, and improve proposal processes.

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.

Perform clinical data cleaning, query management, data reconciliation, UAT and database setup support from start-up through database lock. Maintain DM documentation per SOPs and ICH/GCP, track CRFs, perform QC and training, and collaborate with study teams to ensure data quality and compliance.

Monitor and implement clinical trials ensuring compliance with ICH-GCP and local regulations. Qualify and initiate sites, verify source data, manage IP accountability and SAE reporting, reconcile essential documents, update tracking systems, facilitate audits, mentor junior CRAs, and support cross-functional trial issue resolution.

Lead country-level study delivery for assigned clinical trials: manage local teams, oversee pCRO/CTM/SCP, drive startup and recruitment, ensure TMF/ISF completeness, maintain GCP and regulatory compliance, manage risks and quality events, support vendor management and site technology implementation, and provide subject matter expertise and local intelligence to global study teams.

Serve as a strategic HR partner for Early Phase clinical units, designing and implementing HR solutions, advising leaders on employee relations, talent development, workforce planning, onboarding, and organizational effectiveness. Lead HR projects and global processes, coach managers, manage complex employee relations, and mentor HR colleagues to drive performance and culture.