Jobs at Fortrea

Serve as the FSP subject-matter expert and strategic partner to sales and BD, develop and grow FSP business with biotech and pharma clients, support RFI/RFP responses and pricing, manage pipelines in SFDC, lead client presentations, mentor account teams, and create long-term account plans to achieve sales targets and customer retention.

Lead and coordinate site start-up activities for clinical studies, serving as primary site contact. Manage site selection, regulatory submissions, document collection, TMF maintenance, contract/budget negotiation, site training/support, and cross-stakeholder communication to ensure compliant, timely site activation and study progress.

Lead clinical data management from study start-up to database lock, oversee DM deliverables and teams, liaise with sponsors, manage timelines/budgets/scope, mentor staff, ensure GCP/SOP compliance, coordinate cross-functional biometrics activities, support audits, and drive process improvements and client satisfaction.

Conduct clinical trial site monitoring from pre-study through close-out, ensuring ICH GCP, protocol, regulatory, subject-protection, data-integrity, and investigational-product requirements are met. Responsibilities include source data verification, eCRF review, query resolution, regulatory document maintenance, SAE follow-up, site initiation training, monitoring-plan implementation, audit readiness, study-team coordination, reporting, and substantial travel to study sites.

Manages clinical and non-clinical supplies, clinical documents, labeling requirements, translations, study tools, and correspondence. Updates CTMS databases and trackers, supports eTMF reconciliation, documents supply destruction, and executes eTMF quality control plans. Requires knowledge of ICH-GCP and clinical trial processes, strong organization and communication skills, and at least 1.5 years of relevant industry experience.

Lead end-to-end delivery of Phase I/Ib clinical pharmacology studies, manage sponsors and cross-functional teams, own scope/timelines/budgets, mitigate risks, ensure compliance (TMF/CTMS/ICH-GCP), mentor teams, support bids and process improvements to scale early‑phase programs.

Conducts clinical trial site monitoring and management, including initiation, routine monitoring, closeout, source document review, data query resolution, audit readiness, SAE follow-up, regulatory submissions, vendor coordination, and investigator communications. Leads limited-scope projects, supports protocol and report development, manages registries and study supplies, mentors junior staff, and may coordinate local projects. Requires substantial travel, including 60–80% overnight travel.

Leads Phase I clinical research projects from strategy through completion, managing scope, timelines, budgets, resources, risks, quality, client relationships, regulatory compliance, and contracted deliverables. Builds and mentors high-performing matrixed teams, oversees project governance and financial tracking, drives proactive issue resolution, and supports client presentations and change-order processes. Requires global clinical project management experience in a pharmaceutical or CRO environment.

Manages clinical trial sites and conducts monitoring visits from pre-study through close-out. Verifies informed consent, protocol compliance, source data, regulatory documents, investigational product accountability, and data integrity. Resolves queries, tracks safety events and supplies, maintains eClinical systems, prepares monitoring plans and reports, supports site initiation training, and ensures audit readiness and study timelines. Requires independent site monitoring, knowledge of ICH GCP and regulatory requirements, strong organization, and approximately 60% travel to study sites.

Conducts clinical study site monitoring and management, including pre-study, initiation, routine monitoring, and closeout visits. Ensures informed consent, protocol compliance, patient protection, data integrity, audit readiness, and regulatory adherence. Reviews source documents and CRFs, resolves data queries, tracks safety reporting, manages vendors and study supplies, prepares reports, supports investigator recruitment and submissions, and assists with site budgets, training, and project coordination. Frequent travel, including air travel, may be required.

Lead clinical programming and EDC solutions using SAS and EDC tools (Medidata RAVE/Oracle Inform). Develop and validate SDTM and custom datasets, build visual analytics (Spotfire/Tableau), perform post‑production EDC changes, conduct peer review/QA, plan and oversee study programming activities, and serve as SME and lead statistical programmer to ensure standards, automation, and data reconciliations are met.

Leads operations and performance for one or more Phase I clinical pharmacology sites. Oversees staffing, training, budgets, quality, compliance with protocols and ICH/GCP, study execution, safety, data accuracy, process improvement, client service, audits, and strategic site expansion. Partners with medical, quality, legal, finance, sales, and client services teams to meet operational, financial, scientific, and client objectives.

Manages and monitors clinical trial sites across study phases, ensuring ICH GCP, regulatory, protocol, consent, data integrity, and audit-readiness compliance. Performs source document verification, eCRF review, query resolution, regulatory document maintenance, investigational product accountability, SAE follow-up, trip reporting, site training, and study team coordination. Based in Perth, the role requires independent site monitoring and approximately 60% interstate travel.

Conducts clinical study site monitoring and management for unblinded trials, including pre-study, initiation, routine monitoring, and closeout visits. Ensures protocol compliance, patient protection, data integrity, audit readiness, and accurate reporting. Coordinates with investigators, vendors, internal teams, and regulatory authorities; manages study supplies, submissions, feasibility activities, adverse event follow-up, CRF review, and data queries. Air travel and site visits are essential.

Manage end-to-end pharmacovigilance case workflows: process and track adverse event reports, generate narratives and coding, submit expedited SAE reports to clients and regulators, reconcile safety databases, monitor compliance and timelines, coordinate across teams, support audit/inspection readiness, and resolve workflow delays to ensure high-quality safety operations.

Manage preparation, negotiation, and administration of site and confidentiality agreements for clinical trials. Ensure compliance with SOPs and ICH GCP, maintain contract records, track status in systems, escalate issues, support internal review processes, collaborate with study teams/legal/PM, and contribute to process improvements and status reporting.

Leads business development and Account Executive teams across South Korea, India, Australia, New Zealand, Thailand, and Taiwan. Responsibilities include territory planning, sales forecasting, account development, client relationship management, pricing negotiations, team hiring and coaching, pipeline management in Salesforce, market intelligence, strategic partnerships, and executive reporting. Requires extensive pharmaceutical and biotechnology services sales experience, global collaboration, leadership, negotiation, and frequent international travel.

The Manager of Business Intelligence leads a team of analysts, focusing on delivering actionable data insights, project management, and process improvement while ensuring data accuracy and team development.

Lead site monitoring and management activities for clinical studies, ensuring regulatory compliance, data integrity, SAE tracking, audit readiness, and efficient resource use. Perform initiation, routine, and closeout visits; prepare trip reports; manage small projects, vendor interactions, registry administration, and feasibility. Train and mentor junior staff, assist with protocol/CRF development, and coordinate local project tasks. Significant travel required.

Monitor and manage clinical trial sites per SOPs, ICH GCP and sponsor requirements. Conduct site visits (initiation, routine, close-out), source data verification, query resolution, regulatory document oversight, IP accountability, SAE tracking, eClinical system use, and ensure audit readiness. Travel to sites (~60%) and act as Lead CRA when assigned.