Global Study Manager – Global Study Lead

This is a fully remote position, open to applicants in Bulgaria.

📋 Description

• The GSM will be responsible for the timely, quality-driven, and budget-compliant operational execution of clinical studies, adhering to company standards and scientific guidelines while facilitating swift decision-making and guiding the study team to achieve overall deliverables.

• The GSM is accountable for key deliverables including the Study Initiation Meeting, Clinical Study Activity Plan, Study Delivery Plan, TMF Quality Strategy Document, DCT Setup, Vendors Oversight Plan, Investigator/CRA Meeting Setup along with associated training, Recruitment Tracking, Budget Monitoring, eTMF filing, Vendor Setup and Management, and the Safety Management Plan eTMF & vendor setup.

• Proactively identifies, manages, and mitigates risks associated with the study in an effective manner.

• Ensures clear communication with stakeholders regarding study status, expectations, risks, and issues.

• Responsible for operating within the designated study budget.

• Effectively leads empowered matrix teams to achieve study objectives.

• Provides operational insights for the development of protocols, informed consent forms, and other essential study documents.

• Facilitates and conducts investigator meetings and other relevant study-related gatherings.

• Drives quality initiatives to ensure compliance with protocols and maintains readiness for inspections for assigned studies.

• Supervises the activities of countries participating in the study.

⛳️ Requirements

• A Bachelor’s degree in life sciences or a related field is required.

• Minimum of 5+ years of relevant experience in study management on a global scale.

• Extensive experience in clinical research, focusing on study management, monitoring, and data management.

• Prior in-depth experience in the Oncology field is necessary.

• Must have comprehensive exposure to “end-to-end” clinical study management globally across regions such as NA, EMEA, APAC, LATAM – including China & Japan, with Africa being an advantage.

• Proven experience from study feasibility through to Clinical Study Report (CSR) is essential.

• A minimum of Phase II and Phase III experience is required; Phase I & IV experience is a plus.

• Demonstrated ability in cross-functional leadership and driving both internal and external meetings.

• Capable of contributing to clinical protocol, ICF, and other study plans; knowledgeable in clinical study risk management and clinical systems.

• Strong experience in managing clinical budgets is essential.

• Significant experience in vendor management, including oversight of Contract Research Organizations (CROs).

• Familiarity with inspections from competent authorities (FDA, EMA, MHRA, PMDA, etc.) and involvement in studies critical for drug registration is an asset.

• Proficient in English, with the ability to negotiate and discuss complex topics with any member of the clinical team, including local representatives, statisticians, data managers, laboratory personnel, scientific writers, safety representatives, study physicians, and various vendors, as well as present clear updates to upper management when needed.

• Excellent stakeholder management and communication skills, both oral and written, along with outstanding interpersonal abilities.

• Exhibits leadership qualities, fostering motivation and empowerment in others to achieve individual, team, and organizational goals.

• Strong understanding of clinical studies, drug development, sample management, and associated processes and quality requirements, including ICH/GCP guidelines and Standard Operating Procedures (SOPs).

• Good project management skills, encompassing scope, budget, timeline, and resource planning and management, along with utilization of relevant tools and support when available.

🏝️ Benefits

• Options for remote work are available.