Lead and coordinate the delivery of clinical and evidence generation studies from planning through close-out.
Work with study teams, vendors, and country colleagues to keep studies on time, on budget, and compliant with standards.
Monitor study conduct and progress; identify, resolve and escalate risks/issues.
Draft and review key clinical documents (Protocol, ICF) and study plans.
Coordinate meetings and collaboration with internal teams and external partners (CROs, vendors).
Support GSM in CRO oversight and delivery of delegated activities.
Serve as primary vendor contact for study-specific deliverables.
Provide country-level oversight: recruitment, data completeness, deviations, regulatory compliance.
Manage study communications: meetings, newsletters, action logs and team rosters.
Oversee clinical supply and investigational product delivery; identify risks and propose mitigations.
Ensure eTMF inspection readiness; maintain completeness and quality of study documentation.
Oversee budget tracking, change orders and expenses; ensure alignment with agreements and escalate issues.
Actively contributes to Study Leadership and Central Study Teams; foster team dynamics and change adoption.

At least 3+ years of relevant work experience in a pharmaceutical/scientific environment.
Knowledge of clinical trials, drug development process.
Strong knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards.
Well familiar with key systems used in clinical trial delivery.
Experience in using Trial Master File industry accepted standard.
Project management skills (preferably with analytical/financial skills) and good leadership skills.
Excellent verbal and written communication in English.
Strong knowledge of, and skills in applying, applicable clinical trial regulatory requirements, i.e. GCP and ICH guidelines.
Ability to manage multiple competing priorities with leadership guidance across various clinical studies with good planning, time management and prioritization skills.
Logical/analytical thinking and an inclination to spot patterns and outliers.
Quality mindset, critical sense, attention to details, effective training and mentoring skills.
Knowledge of project finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports.
Excellent comprehension of Microsoft Office tools and CTM systems.
Good stakeholder management and communication skills (oral and written), strong interpersonal skills.
Results driven and efficient
Ability to adjust to work in cross-functional squads in the agile model.

Study Manager

Key skills