Global Study Manager

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

📋 Description

• Leads and participates in the development of assigned study documents (e.g., Informed Consent Form, master Clinical Study Agreement, etc.)

• Manages and promotes collaboration with internal departments such as Enablement, Data Management, Procurement, Regulatory, Patient Safety, and Quality Assurance, as well as external parties including CROs and other service providers to ensure timely, cost-effective, and quality-driven study execution.

• Aids in the organization and execution of both internal and external meetings (e.g., Investigators’/Monitors’ meeting).

• Ensures availability of Investigational products and study materials by coordinating with the Clinical Supply Chain or relevant external service providers.

• Actively engages in identifying risks and issues, as well as developing mitigation and action plans for those identified challenges.

• Confirms that all study documents under the GSM’s purview are completed and verified for quality within the Trial Master File.

• Assists GSD/GSAD with budget oversight, including the reconciliation of invoices from external service providers.

• Complies with global clinical processes, procedural documentation, relevant Quality & Compliance manuals, and international standards such as ICH/GCP to ensure the study remains inspection-ready at all times.

• Provides support to GSADs in project management according to the established delegation.

• For outsourced studies, aids GSD/GSAD in overseeing the CRO Project Manager to ensure study delivery aligns with agreed timelines, budgets, and quality benchmarks, while maintaining and documenting the appropriate level of CRO oversight throughout the study lifecycle, in accordance with relevant SOPs and guidelines (e.g., service descriptions and obligation transfers).

⛳️ Requirements

• University degree (or equivalent), ideally in medical or biological sciences, or a discipline related to clinical research.

• Relevant experience in the pharmaceutical industry or a comparable organization, or academic experience, with a preference for at least 3 years.

• Experience in global study management with a strong emphasis on managing vendors and external partners.

• Knowledge of the clinical development and drug development processes across various phases and therapeutic areas.

• Strong understanding of international guidelines such as ICH/GCP.

• Exceptional communication and relationship management skills, including the ability to manage external service providers effectively.

• Solid project management skills.

• Proven ability to collaborate as well as work independently.

• Demonstrated leadership capabilities.

• Proficient in computer usage, with advanced skills applicable to daily tasks.

• Excellent verbal and written communication skills in English.

• Experience in early-phase oncology is required.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Wellness programs that include medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.