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Lead country/regional study operations from startup through close, overseeing CROs and site activation, managing timelines, budgets, risks, recruitment, vendor deliverables, and resolving escalations to ensure timely study delivery and compliance.

The Manager, Data Analysis oversees centralized monitoring for clinical trials, ensuring effective RBQM systems, data analysis, and reporting while collaborating with cross-functional teams.

Support Marketing and Sales to generate campaigns and leads, analyze opportunities, schedule introductory business development calls, respond to inbound web leads, track prospect/client activity in CRM, and collaborate with sales leaders to develop market strategies across Parexel service lines.

Support study management across clinical trials by maintaining tracking systems, coordinating documentation and training, managing TMF and supplies, conducting quality control reviews, liaising with sites/CROs/vendors, assisting budgeting/invoice tracking, and leading assigned project activities to ensure compliant, timely execution per ICH/GCP and regulatory requirements.

Lead design and reporting of end-to-end labeling KPIs and dashboards, ensure data integrity and governance, support compliance forums, audits, and digital enablement, and provide analytic insights to drive process improvements and CAPAs while offering cross-trained operational backup.

Lead and deliver global clinical study start-up strategy and site activation plans. Coordinate regulatory submissions, timelines, and cross-functional teams, manage risks and escalations, and ensure sites are activated to enroll participants on schedule.

Support clinical/scientific conduct of studies including medical monitoring, adjudication support, imaging reconciliation, protocol deviation management, and stakeholder liaison. Prepare meeting materials and ensure compliance with GCP and company processes.

Lead end-to-end labeling process management including deviation/CAPA investigations, process governance, systems stewardship (Veeva RIMS, TrackWise, QDocs, Documentum), audit and inspection readiness, and cross-functional process improvements. Develop training and support regulatory intelligence, ensuring compliant labeling operations, KPI oversight, and coordination with Regulatory, Pharmacovigilance, Quality, and Manufacturing.

The role involves leading regulatory CMC strategy for peptide and oligonucleotide therapeutics, driving submissions, and ensuring compliance with relevant standards.

The Consultant will provide statistical expertise in meta-analysis, collaborate on evidence generation plans, and guide junior staff in a multi-disciplinary research environment.