Jobs at Parexel

Perform clinical data management for Phase I-IV studies: design and test eCRFs/EDC, develop edit checks and DMPs, manage queries, reconcile external data and SAEs, support database lock, and collaborate with cross-functional teams and vendors.

The role involves managing clinical trial budgets and contracts, negotiating with stakeholders, and ensuring compliance with regulations. Responsibilities include budget development, contract negotiations, and cross-functional collaboration to optimize clinical research support.

Lead global regulatory strategy and project execution across product development, registration, and post-marketing activities. Partner with Global Regulatory Leads, coordinate cross-functional teams, manage milestones, risks, timelines, and submission readiness, and facilitate regulatory subteam meetings. Prepare dashboards and scenario plans for senior stakeholders while supporting U.S., EU, and global regulatory programs, including IND, BLA, and MAA submissions for vaccines and other therapies.

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.

Monitor clinical sites through qualification, initiation, monitoring and close-out visits. Build site relationships, ensure patient safety and regulatory/GCP compliance, verify data quality and drug accountability, manage regulatory documentation, and support recruitment strategies to meet enrollment timelines.

Support regulatory pathway planning and agency engagement for vaccines/biologics. Develop pathway recommendations, prepare meeting materials and submissions, identify regulatory risks/opportunities, track timelines, and collaborate cross-functionally to ensure compliance and alignment with development and commercialization objectives.

Lead and coordinate end-to-end global clinical trial execution, overseeing CROs, vendors, study startup, monitoring, budgets, and inspection readiness. Develop and approve study-level plans (monitoring, training, TMF), drive operational strategy with cross-functional teams, and mentor Study Operational Managers. Ensure delivery against timelines, manage vendor spend and risks, and support decentralized/site capabilities and regulatory readiness.

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.

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.

Lead country-level study operations from startup through close, overseeing local teams, vendors (pCRO/CTM/SCP), timelines, budgets, risks, and compliance. Provide operational input, manage site activation and recruitment strategies, ensure TMF completeness, support new technologies (eConsent, eISF, remote SDV/SDR, iConnect), and liaise with global stakeholders to resolve escalations and optimize study delivery.

Lead global site activation for assigned clinical trials, develop and execute site/country start-up strategies, oversee CRO and internal SSU teams, ensure TMF inspection readiness, support regulatory submissions, track metrics and risks, and drive process improvements while collaborating cross-functionally.

Lead and support site start-up and activation for assigned studies: compile Investigator Initiation Packages, coordinate regulatory and ethics submissions, update clinical trial systems, manage cross-functional activities, resolve site issues, and ensure compliance with GCP, sponsor standards, and study timelines.

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.

Supports coordination and administration of clinical studies from start-up through closeout. Manages local eTMF/ISF, prepares and tracks regulatory and site documents, assists submissions to EC/IRB and regulatory authorities, coordinates meetings, site contracts and payments, and ensures inspection readiness and compliance with ICH-GCP and local regulations.

Lead country-level study operations from startup through close for one or more clinical trials. Oversee local study teams and CROs, manage startup, site activation, recruitment strategies, vendor oversight, risk and issue mitigation, and ensure timely delivery of study plans and quality event follow-up.

Lead country-level Local Study Teams to deliver clinical study responsibilities (site identification, start-up, monitoring, documentation, budgets, and regulatory submissions) ensuring ICH-GCP and client compliance; support recruitment strategy, risk management, training, audits, and stakeholder communication. Oncology experience required; cell therapy preferred.

The Senior CRA ensures quality site management and monitoring of clinical trials, addressing protocol-related issues while maintaining compliance and investigator relations.