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 contribute to Study Leadership and Central Study Teams; foster team dynamics and change adoption.

Requirements

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 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.

Benefits

Medical Plan
Life Insurance
Employee Retirement Program
Sport and recreation cards
Recreation allowance
Annual bonus

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trialsdrug development processICH-GCPclinical study delivery processTrial Master Fileproject managementbudget trackingregulatory complianceanalytical skillsfinancial skills

Soft Skills

leadershipcommunicationplanningtime managementprioritizationlogical thinkinganalytical thinkingattention to detailtraining skillsinterpersonal skills