Study Manager – FSP

This is a fully remote position, open to applicants in Bulgaria, +4 more countries.

📋 Description

• Contribute to the timely delivery of clinical studies, ensuring adherence to cost and quality targets while maintaining readiness for inspections.

• Drive initiatives for continuous improvement and disseminate best practices throughout the organization.

• Collaborate with the Study Delivery Lead to oversee comprehensive operational study delivery from setup to archival.

• Establish, maintain, and verify the completeness of internal systems, databases, tracking tools, and project plans.

• Work collaboratively with both internal and external stakeholders on clinical study management tasks across various phases and therapeutic areas.

• Monitor the execution and progress of studies, identifying, resolving, and escalating risks and issues related to delivery.

• Review essential clinical documents, including protocols and informed consent forms.

• Lead the creation of study plans, encompassing monitoring, vendor management, protocol deviation management, risk management, and communication strategies.

• Organize and maintain meetings and interactions with regulatory bodies, local operating companies, quality assurance teams, CROs, and third-party vendor partners.

• Manage vendors and oversee CRO activities, including deliverables and delegated tasks.

• Provide oversight at the country level, tracking recruitment, data completeness, compliance, protocol deviations, risks, regulatory approvals, and import license statuses.

• Coordinate study-related tasks and manage team communications, meetings, minutes, info-spaces, newsletters, action logs, team lists, and communication plans.

• Oversee the distribution of clinical supplies, investigational products, and study materials; communicate risks and suggest solutions.

• Ensure data oversight and maintain eTMF completeness and quality for readiness during inspections.

• Manage budget oversight, including task/change orders, expenses, system updates, agreements, and issue escalation.

• Contribute to agile squads and potentially assume the role of Scrum Master.

• Carry out study activities independently across various study types with minimal guidance from the Study Delivery Lead.

• Mentor junior colleagues.

⛳️ Requirements

• Bachelor's degree or equivalent, preferably in medical or biological sciences or a field related to clinical studies.

• A minimum of 3 years of relevant experience in a pharmaceutical or scientific setting.

• Understanding of clinical trials and the drug development process.

• Comprehensive knowledge of ICH-GCP, clinical study delivery processes, regulations, operational best practices, and industry standards.

• Familiarity with essential systems utilized in clinical trial delivery.

• Experience with an industry-recognized Trial Master File standard.

• Strong project management capabilities, preferably including analytical and financial skills.

• Good leadership abilities.

• Proficient verbal and written communication skills in English.

• Excellent communication and relationship-building skills, including managing external service providers.

• Knowledge of relevant clinical trial regulatory requirements, including GCP and ICH guidelines.

• Ability to manage multiple competing priorities using effective planning, time management, and prioritization skills.

• Capacity to think independently, analyze, and solve problems in a systematic and creative manner, while adopting a risk-based approach.

• Established expertise and seniority in the area and function.

• Logical and analytical thinking, pattern recognition, quality mindset, critical sense, and attention to detail.

• Effective skills in training and mentoring.

• Strong understanding of project planning and management principles.

• Knowledge of project finance and accounting principles, including budgets, invoices, cross-charges, and expense reports.

• Proficient in Microsoft Office tools, including Excel, PowerPoint, Word, and Outlook.

• Familiarity with advanced Excel, timelines/budget tracking systems, and clinical trial management systems.

• Exceptional stakeholder management and communication skills, both oral and written.

• Outstanding interpersonal abilities.

• Excellent networking and stakeholder influence capabilities.

• Capability to facilitate and lead cross-functional meetings, challenge inefficient processes, and act as a mediator.

• Results-oriented and efficient; possesses a motivated and dynamic personality.

• Adaptability to work in a changing and challenging environment and to coach study team members.

• Ability to operate within cross-functional squads using an agile framework.

• Collaborative spirit and ability to work across cultures and geographies with an awareness and understanding of cultural differences.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.