Global Clinical Trial Manager II or Senior, Home based Poland

Syneos Health, Inc.; Polska; Remote; PLN 180,000 - 280,000; Full time

Job summary

Syneos Health is seeking a Global Clinical Trial Manager II or Senior for a home-based role in Poland. You will lead comprehensive trial management across phases, coordinating with investigators, study teams and operations to ensure protocol adherence, data integrity, and patient safety from startup through closeout.

The role emphasizes partnership with cross-functional groups and global regulatory compliance, enabling flexible work arrangements while maintaining rigorous project governance and

Responsibilities

• Roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase 1 through to Phase 4 clinical research studies at the organization's facilities.

Job description

Global Clinical Trial Manager II or Senior, Home based Poland

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.


• We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.


• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase 1 through to Phase 4 clinical research studies at the organization's facilities. Collaborates with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plans logistics and resource usage. Tracks study progress in alignment with project milestones, client deliverables, and budget, and follows applicable regulations globally and by region.

Impact and Contribution

Includes executives as well as managers, supervisors and team leads providing strategic vision and/or tactical direction across a discipline and/or broader organization. The majority of time is spent overseeing their area of responsibility, planning, prioritizing, and/or directing the responsibilities of employees. Goal are achieved through management of process, policy, and performance of direct and/or indirect reports. Supervises experienced support employees and/or entry individual contributors. Delivers operational results that have moderate impact on the immediate achievement of results for the team. Broad job knowledge in an operational, administrative and/or specialized field, adapts new procedures, techniques, tools, etc. Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution.

Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.

• Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities.


• May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).


• Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters.


• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.


• Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.


• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.


• Participates and presents in key meetings such as Kick Off Meeting.


• Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution.


• Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews an