Jobs at Parexel

Supports pharmacovigilance and patient safety operations, including individual case safety report processing, data entry, quality checks, coding, narratives, literature review, regulatory submissions, affiliate support, reconciliation, and regulatory intelligence. Maintains safety and regulatory records in relevant systems, supports compliance with global requirements, and participates in audits, inspections, training, and project activities while escalating issues appropriately.

Manages vendor and third-party quality events, deviations, CAPAs, audits, risk assessments, due diligence, and compliance activities across clinical research and Medical Affairs. Supports third-party governance, regulatory readiness, quality documentation, process improvement, training, and stakeholder collaboration. The role requires pharmaceutical or CRO experience, knowledge of GxP, GCP, GVP, FDA, EMA, ICH, quality systems, clinical study management, external suppliers, and regulatory requirements.

Leads site activation strategy and execution for clinical trials from feasibility through activation. Coordinates critical paths, regulatory and ethics submissions, documentation, systems, timelines, risks, resources, and cross-functional teams. Manages client and investigator communications, oversees quality and compliance, mentors site activation staff, supports proposals, and drives process optimization across multiple studies and therapeutic areas.

Leads international pharmaceutical congresses and meetings from planning through post-event analysis. Manages delegate logistics, venues, suppliers, budgets, client relationships, compliance, project deliverables, and on-site execution. Provides quality control, resolves issues, monitors profitability, and supports virtual meeting and registration technology. Requires conference management experience in pharmaceutical, clinical research, or healthcare settings, strong communication and organizational skills, proficiency with Microsoft Office, and a bachelor’s degree.

Manages clinical trial sites throughout study phases, serving as the primary site contact and ensuring compliance with protocols, ICH-GCP, regulations, and quality standards. Conducts remote and on-site monitoring visits, oversees documentation, recruitment, performance, and corrective actions, and collaborates with investigators, vendors, regulatory authorities, and internal teams. Supports audits and inspections, mentors junior CRAs, contributes to process improvement, and manages multiple protocols and sites independently with substantial travel.

Conduct clinical site qualification, initiation, monitoring, and termination visits; maintain site relationships; protect participant safety; support recruitment; ensure protocol, GCP, SOP, regulatory, data quality, and documentation compliance; and resolve site issues independently across multi-sponsor clinical trials.

Lead and manage global clinical trial project teams for biotech clients (oncology and other therapeutics). Oversee day-to-day operations, scheduling, resource and budget management, regulatory submission support, and ensure on-time, on-budget, high-quality delivery. Provide strategic direction, problem-solving, and stakeholder communication across multidisciplinary teams.

Lead and manage global clinical trial teams for biotech clients (Dermatology and other therapeutic areas). Oversee day-to-day operations, scheduling, resource and budget management, ensure on-time high-quality delivery, coordinate team activities, and support full clinical development through regulatory submissions.

Coordinates clinical trial site activation from study start-up through close-out. Responsibilities include investigator site readiness, regulatory and ethics submissions, essential document management, clinical system maintenance, audit and inspection support, issue resolution, and trial master file contributions. The role collaborates with investigator sites, study teams, vendors, and regulatory stakeholders to ensure compliant, timely site activation and study execution.

The role involves leading project teams for clinical trials, managing operations, budgets, and ensuring timely delivery to exceed client expectations.

Lead global clinical trial project teams for biotech clients, managing daily operations, schedules, resources, budgets, and team coordination. Ensure projects are delivered on time, within budget, and to high quality standards through the full clinical development process, including regulatory submissions. The role requires strong problem-solving, strategic, interpersonal, organizational, and computer skills, with a focus on dermatology studies.

Manages end-to-end RFPs, proposal development, pricing, budgets, contract negotiations, and client meetings for clinical research services. Coordinates cross-functional stakeholders across operations, project management, legal, business development, and finance. Maintains contract standards, mitigates proposal and contracting barriers, meets strict deadlines, and ensures accurate documentation and KPI tracking. The role requires knowledge of clinical trial processes, contract management, pricing structures, cash flow, and revenue recognition.

Leads clinical data management activities across assigned studies, overseeing timelines from study startup through database lock. Coordinates global cross-functional teams, ancillary systems, quality compliance, audits, issue resolution, resourcing, financial management, and sponsor deliverables. Reviews metrics, manages risks, supports proposals, maintains inspection readiness, provides training, and mentors data management staff. Requires extensive clinical data management experience, Medidata Rave expertise, knowledge of regulatory standards, and leadership of project teams.

Oversee country-level clinical trial delivery from site identification through closeout, ensuring timelines, budgets, quality, ICH-GCP compliance, and local regulatory adherence. Lead local study teams, coordinate monitoring and site activities, manage essential documents, budgets, risk plans, regulatory submissions, and investigator relationships. Support patient recruitment and conduct site monitoring as needed. Requires clinical research experience, project leadership, life sciences education, regulatory knowledge, and strong organizational and communication skills.

Manages investigator sites throughout clinical trials, including site activation, monitoring, recruitment support, compliance, patient safety, investigational product oversight, issue resolution, documentation, database release, and close-out. Ensures adherence to protocols, ICH/GCP, FDA and local regulations, while coordinating with study teams, sponsors, vendors, investigators, and safety units. The role requires extensive travel and may include unblinded monitoring responsibilities.

Manages clinical trial investigator sites from activation through close-out, ensuring patient safety, regulatory and GCP compliance, quality, recruitment, monitoring, documentation, and issue resolution. Conducts onsite and remote monitoring, oversees investigational product handling, supports database release, addresses adverse events and data queries, develops corrective actions, and partners with study teams, investigators, vendors, and site personnel. Requires clinical research monitoring experience, life sciences education, extensive travel, and valid driving and passport credentials.

Manages global clinical trials from study start-up through closeout, including site activation, recruitment strategy, study planning, vendor oversight, budget management, and cross-functional coordination. Supports international oncology research programs and ensures timely, compliant delivery of study activities. The role requires independent judgment, strong communication, organizational skills, and collaboration with global, local, internal, and CRO teams.

Designs and delivers global pharmacovigilance solutions, supporting pre-sales proposals, budgets, commercial development, post-award account management, client relationships, and delivery oversight. The role requires strong stakeholder management, consulting expertise, process improvement, and automation knowledge, partnering cross-functionally to provide scalable, high-quality drug safety services.

Provides CMC regulatory strategy, submission preparation, and compliance support for biologic, small-molecule, and drug-device products. Collaborates with manufacturing, quality, regulatory, and partner teams; supports FDA, EMA, and Health Canada submissions and meetings; addresses GMP requirements; manages post-approval changes; and improves regulatory processes. The role requires extensive pharmaceutical CMC experience, knowledge of global regulatory requirements, and expertise preparing IND, NDA, DMF, and equivalent quality submissions.

Develop and manage scientific medical communications projects independently, including researching, writing, editing, proofreading, quality control, and stakeholder collaboration. The role requires interpreting scientific data, applying therapeutic-area knowledge, delivering projects on schedule, and maintaining strong client and external expert relationships. A life sciences, pharmacy, or medicine degree, preferably with an advanced qualification, is required. This is a six-month maternity cover with possible extension.