Global Study Manager – Single Sponsor

Role Overview

• Leads/contributes to the preparation of delegated study documents (e.g., Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.).
• Maintains and facilitates interactions with internal functions and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives.
• Contributes to the planning and conduct of internal and external meetings (e.g., Investigators’/Monitors’ meeting).
• Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
• Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
• Ensures that all study documents in scope of GSM’s responsibilities are complete and verified for quality in Trial Master File.
• Supports GSD and/or GSAD with budget management, such as external service provider invoice reconciliation.
• Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times.
• Supports GSD and/or GSAD with overall project management as per agreed delegation.
• For outsourced studies, supports GSD and/or GSAD in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with Internal BioPharmaceuticals Clinical Operations Job Description relevant client's SOPs and guidelines (e.g., description of services and transfer of obligations)
• Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Requirements

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
• Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
• Knowledge of clinical development / drug development process in various phases of development and therapy areas
• Excellent knowledge of international guidelines ICH/GCP
• Excellent communication and relationship building skills, including external service provider management skills
• Good project management skills
• Demonstrated ability to collaborate as well as work independently
• Demonstrated leadership skills
• Computer proficiency, advanced computer skills in day-to-day tasks
• Excellent verbal and written communication in English.

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development opportunities