Global Study Manager – FSP

This is a fully remote position, open to applicants in Bulgaria, +2 more countries.

📋 Description

• This role is responsible for managing the clinical operational activities of the study until it is archived.

• It entails creating robust and expedited delivery plans, with an emphasis on achieving upper quartile performance, and successfully meeting target or stretch thresholds while ensuring quality.

• The GSM position collaborates with the Global Study Lead for comprehensive delivery of the clinical study.

• The GSM is accountable for the operational execution of clinical studies, ensuring adherence to timelines, quality standards, budget constraints, company policies, and scientific requirements, while facilitating swift decision-making and guiding the study team to meet overall study objectives.

• The GSM is tasked with the following deliverables: Study Initiation Meeting.

• Clinical Study Activity Plan.

• Study Delivery Plan.

• TMF Quality Strategy Document.

• DCT Set Up.

• Vendors Oversight Plan.

• Investigator/CRA Meeting Setup & associated training.

• Recruitment Tracking.

• Budget tracking.

• eTMF filing and Vendor Set Up and Management.

• Safety Management plan.

• eTMF & vendor setup.

• Proactively identifies, monitors, and mitigates study risks effectively.

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

• Accountable for operating within the established study budget.

• Effectively leads empowered matrix teams.

• Responsible for providing operational input into the development of the protocol, informed consent form, and other essential study documents.

• Leads and facilitates investigator meetings and other study-related gatherings.

• Drives quality initiatives to ensure adherence to protocols and maintains continual inspection readiness for assigned studies.

• Oversees the activities of participating countries in the study.

⛳️ Requirements

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

• A minimum of 5+ years of relevant global study management experience.

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

• Prior in-depth experience in Oncology.

• Must have global exposure to clinical study management from end-to-end, including NA, EMEA, APAC, and LATAM regions, with China & Japan and Africa experience being advantageous.

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

• At least Phase II and Phase III experience is required; Phase I & IV experience is a plus.

• Demonstrated cross-functional leadership experience, with the ability to facilitate internal and external meetings.

• Capable of contributing to clinical protocol, informed consent form, and other study plans, with a strong understanding of clinical study risk management and clinical systems.

• Strong skills in clinical budget management.

• Significant experience in vendor management, including working with Contract Research Organizations (CROs).

• Familiarity with competent authority inspections (FDA, EMA, MHRA, PMDA, etc.); involvement in studies critical for drug registration is a plus.

• Fluent in English, capable of negotiating and discussing complex topics with any clinical team member (local country representative, statistician, data manager, laboratory staff, central laboratory, scientific writer, safety representative, study physician, and various vendors), and able to clearly present status updates to upper management when necessary.

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

• Demonstrated leadership qualities that foster motivation and empowerment in others to achieve individual, team, and organizational goals.

• Strong understanding of the clinical study process, drug development, sample management, and related quality requirements, including ICH/GCP guidelines and SOPs.

• Good project management skills, encompassing scope, budget, timeline, and resource planning and management, along with proficiency in relevant tools and support where available.

🏝️ Benefits

• Opportunities for professional development.