Project Manager II in Early Phase - Sponsor dedicated - Based in Poland Lisboa

Overview

Project Manager II in Early Phase - Sponsor dedicated - Based in Poland

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient, and we work to simplify and streamline our processes. We offer opportunities in Functional Service Provider partnerships or Full-Service environments, collaborating with multidisciplinary teams to accelerate the delivery of therapies. We are committed to a diverse and inclusive culture where people can belong and grow.

Why Syneos Health: we develop our people through career development, supportive leadership, and training, with a culture that values authenticity and belonging.

Responsibilities

• Project Leadership and Delivery: Manage a project as a project manager overseeing interdisciplinary clinical research studies and ensure compliance with GCP, relevant SOPs, and regulatory requirements.
• Serve as the primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to contractual agreements.
• Lead project team to ensure quality, timelines and budget management; account for the financial performance of each project.
• Coordinate activities and deliverables of study conduct partners; proactively identify and manage issues.
• Ensure studies are conducted in compliance with GCP, SOPs and regulatory requirements; maintain all project deliverables.
• Maintain quality and completeness of TMF for assigned projects; manage study information across databases and systems.
• Oversee development and implementation of project plans; plan, coordinate and present at internal and external meetings.
• Prepare project management reports for clients and management; develop contingency plans and risk mitigation strategies to ensure successful delivery.
• Develop strong relationships with current clients to generate new or
  - on business; participate in bid defense meetings where applicable.
• May be required to
  - manage other project management team members and clinical monitoring staff.

Qualifications

• Bachelor’s Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing, or related field.
• Clinical research organization (CRO) and relevant therapeutic experience preferred; strong knowledge of Good Clinical Practice/ICH guidelines and regulatory requirements.
• Strong organizational skills with the ability to manage time and work independently.
• Direct therapeutic area expertise and ability to embrace new technologies.
• Excellent written and verbal communication, presentation, and interpersonal skills.
• Ability to travel as necessary (approximately 25%).

Additional Information

Tasks, duties, and responsibilities listed are not exhaustive. The company may assign additional tasks at its discretion. The company will determine what constitutes an equivalent qualification. This description is intended to comply with applicable laws and is not a contract of employment. Reasonable accommodations may be provided as required by law.