Associate Director, Trial Master File

Benefits

Qualifications

• •ns: Bachelor’s degree or higher in a scientific or health-related discipline
• •Advanced degrees prefer
• •red
• •Minimum of 8–10 years of clinical research experience within a pharmaceutical, biotech, or CRO sett
• •ing
• •Demonstrated expertise in eTMF governance, inspection readiness, and regulatory compli
• •anceIn‑depth knowledge of ICH GCP (E6 R2/R3), TMF Reference Model, and global regulatory expectat
• •Proven experience operating within a CRO‑heavy or outsourced clinical trial model, including sponsor oversight and vendor manage
• •mentStrong experience with eTMF systems (e.g., Veeva Vault, Trial Interactive, Wingspan) and TMF metrics/
• •KPIsTrack record of supporting audits and health authority inspections as a TMF subject matter ex
• •Strong cross‑functional collaboration skills, with the ability to influence without direct autho
• •rityExcellent written and verbal communication skills, including executive‑level presentation and storytel
• •lingDemonstrated leadership, organizational, and change‑management capabilities in a growing biotech environ
• •Strong understanding of ICH GCP (E6 R2/R3) and health authority expectations related t
• •callyProven inspection‑readiness mindset with the ability to defend TMF strategy and deci
• •sionsDemonstrated ability to provide effective sponsor oversight in outsourced/CRO‑led m
• •odelsStrong risk identification, assessment, and mitigation skills related to TMF quality and compl
• •ianceExperience managing TMF issues, deviations, and
• •CAPAsAbility to distinguish true TMF risk vs
• •noise using data and jud
• •Confident decision‑making balanced with appropriate escal
• •ationCapability to mentor, guide, and set expectations for TMF staff and contra
• •ctorsStrong stakeholder management skills, including communication with senior leade
• •rshipExcellent written and verbal communication skills, including clear, concise executive‑level mess
• •aging
• •Ability to translate detailed TMF data into meaningful insights and narra
• •Proven experience developing and implementing SOPs, work instructions, and governance m
• •odelsStrong change‑management skills in evolving or scaling organiza
• •nd ITDetail‑oriented with strong organizational and prioritization s
• •Travel Required: Up
• •27 more items(s)

Responsibilities

• •y:The Associate Director, Trial Master File at Structure Therapeutics will report to a Director, Vendor Oversight and Process Improvement and The Associate Director, Trial Master File (TMF) is responsible for the strategic oversight, governance, and continuous improvement of the electronic Trial Master File across the clinical trial portfolio
• •This role ensures that TMF processes, systems, and controls support inspection readiness, regulatory compliance, and efficient clinical trial executio
• •n.The Associate Director provides leadership over TMF strategy, vendor oversight, inspection preparedness, and cross‑functional alignment, ensuring TMF completeness, quality, and timeliness throughout the study lifecycle
• •The role serves as a key partner to Clinical Operations, Quality, Regulatory Affairs, and external vendors, maintaining sponsor accountability for TMF integrity while enabling scalable operations as the organization grow
• •iesProvide strategic leadership and sponsor oversight for the electronic Trial Master File (eTMF) across all clinical stud
• •iesEnsure TMF completeness, accuracy, and timeliness throughout the study lifecycle to support continuous inspection readin
• •essLead the development, implementation, and maintenance of TMF governance, including SOPs, work instructions, and guida
• •nceEstablish and monitor TMF performance metrics and KPIs, using data to identify trends, risks, and improvement opportunit
• •iesOversee CRO and vendor TMF activities, ensuring delegated responsibilities are executed in compliance with contractual and regulatory expectati
• •onsServe as the TMF subject matter expert for audits, health authority inspections, and regulatory interacti
• •onsDrive risk‑based TMF oversight, issue management, and CAPA development related to TMF quality or compliance g
• •apsPartner cross‑functionally with Clinical Operations, Quality, Regulatory Affairs, and IT to ensure alignment and effective oversi
• •ghtLead or support TMF system implementation, optimization, and integration activities, including validation and change managem
• •entDevelop and deliver TMF training and guidance for internal teams and external partn
• •ersEnsure clear documentation of sponsor oversight and decision‑making in accordance with ICH GCP and regulatory expectati
• •onsSupport scalability and operational maturity of TMF processes as the clinical portfolio gr
• •owsMentor and guide TMF team members or contractors, as applica
• •pert
• •Experience developing and implementing SOPs, work instructions, and governance framew
• •orksAbility to assess TMF risk, manage issues and CAPAs, and drive continuous improvement initiat
• •TMFAbility to interpret and apply the TMF Reference Model pragmati
• •gmentAbility to lead through influence across cross‑functional and vendor
• •teams
• •tivesSkilled at presenting complex issues with clarity during audits and inspec
• •tionsAbility to balance structure with agility in a growing biotech enviro
• •nmentHighly collaborative, with the ability to work effectively across Clinical Operations, Quality, Regulatory, a
• •kills
• •Comfortable operating in fast‑paced, ambiguous environments while maintaining compl
• •25 more items(s)