Global Study Manager – Project Manager

📋 Description

• Oversees a project as a project manager, managing interdisciplinary clinical research studies while ensuring adherence to GCP, relevant SOPs, and regulatory standards.

• Serves as the main point of contact between the Company and the Customer, facilitating timely study initiation, execution, and closure in line with both parties' contractual obligations.

• Leads the project team to guarantee quality, adherence to timelines, and effective budget management.

• Responsible for the financial performance of each assigned project.

• Coordinates the activities and deliverables of all study conduct partners, proactively identifying and addressing potential issues.

• Ensures that studies are carried out in accordance with GCP, relevant SOPs, and regulatory guidelines.

• Holds accountability for all project deliverables associated with each assigned project.

• Oversees the quality and completeness of the Trial Master File (TMF) for designated projects.

• Responsible for maintaining study information across various databases and systems.

• Manages study oversight components to ensure readiness for inspections related to all aspects of study conduct.

• Provides oversight for the development and execution of project plans.

• Plans, coordinates, and leads internal and external meetings.

• Prepares project management reports for clients and internal management.

• Develops contingency plans and risk mitigation strategies to ensure the successful achievement of study objectives.

• Cultivates strong relationships with existing clients to foster new business opportunities and additional services in the future.

⛳️ Requirements

• Bachelor’s Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing, or a relevant combination of education and experience.

• Preferred experience in a Clinical Research Organization (CRO) and relevant therapeutic areas.

• In-depth knowledge of Good Clinical Practice/ICH guidelines and other pertinent regulatory requirements.

• Strong organizational capabilities.

• Proven ability to manage time effectively and work independently.

• Expertise in direct therapeutic areas.

• Willingness to embrace and adapt to new technologies.

• Exceptional communication, presentation, and interpersonal skills, both written and verbal.

• Availability to travel as required (approximately 25%).

🏝️ Benefits

• We are dedicated to the development of our personnel through career growth and advancement opportunities;

• Supportive and engaged line management;

• Technical and therapeutic area training;

• Peer recognition and a comprehensive rewards program.

• We are committed to fostering an inclusive culture where you can genuinely be yourself.

• Driven to Deliver – a reflection of our colleagues' passion to show up each day and create solutions that can significantly impact lives.