Responsable des contrats commerciaux chez Spiria, créateur canadien de solutions logicielles sur mesure. Révision, négociation et administration contractuelles; gouvernance des programmes de conformité, notamment SOC 2.
About the role
- Study Manager leading and coordinating clinical studies, ensuring compliance and project delivery. Role offers growth via exposure to global study delivery for GSK's mission in healthcare.
Responsibilities
- 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.
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 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.
Benefits
- Medical Plan
- Life Insurance
- Employee Retirement Program
- Sport and recreation cards
- Recreation allowance
- annual bonus
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