Job Title:Sponsor Dedicated Local Clinical Trial Manager II - Temporary (14 months) Home

Job Location:Leeds, UK

Job Location Type:Remote

Job Contract Type:Full-time

Job Seniority Level:Mid-Senior level

Job Description:

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 brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Job Responsibilities:

• 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, including patient recruitment and investigator payments.
• May be responsible for identification of critical data and process, protocol execution risks and risk mitigations.
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team is aware of the contractual obligations.
• Uses prior clinical experience, operational data, metrics, and reports to identify risks to clinical trial management deliverables.
• Escalates risks to clinical trial management deliverables to the project manager.
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participates and presents in key meetings such as Kick Off Meeting.
• Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones.
• Responsible for development and ongoing maintenance of clinical study tools and templates.
• Coordinates initial and ongoing training to the study team regarding protocol specificities.
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables.
• Reviews project oversight dashboards and other clinical trial systems to oversee site and patient activities.
• Understands the monitoring strategy required for the study.
• Reviews the content and quality of site and central monitoring documentation.
• Interacts with the client and other functional departments related to clinical monitoring activities.
• Demonstrates understanding of other functions roles in achieving compliance and delivery according to protocol.
• Oversees CRAs and Central Monitors assigned to the study.
• Provides feedback to line managers on staff performance.
• May be assigned to larger, more complex trials.

Qualifications:

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Demonstrated ability to lead and align teams in the achievement of project milestones.
• Demonstrated capability of working in an international environment.
• Demonstrated expertise in site management and monitoring.
• Preferred experience with risk-based monitoring.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills.
• Good communication, presentation and interpersonal skills.
• Strong conflict resolution skills.
• Demonstrated ability to apply problem solving techniques.
• Moderate travel may be required, approximately 20%.

Additional Information:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion, may assign other tasks, duties, and job responsibilities.

For more details and to find similar roles, please check out the below Lifelancer link.

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