Clinical Trial Manager Full-Service Home Based LATAM

3 semanas atrás


brasília, Brasil Syneos Health, Inc. Tempo inteiro
Clinical Trial Manager Full-Service with experience in USA - Home Based LATAMUpdated:
January 14, 2025Location:
Brazil-Latin America - BRA-Home-BasedJob ID: 25001160
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.
Identifies critical data and process risks related to the completion of the Risk Assessment and Categorization Tool (RACT).
Reviews the study scope of work, budget and protocol content, ensuring the clinical project team is aware of contractual obligations.
Uses prior clinical experience and operational data to identify risks to clinical trial management deliverables.
Escalates risks to the project manager regarding clinical trial management deliverables (timeline, quality, and budget).
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.
Collaborates with 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 specifics and clinical plans.
Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team conduct.
Ensures quality of the clinical monitoring and site management deliverables within a project.
Reviews project oversight dashboards and other clinical trial systems to oversee site and patient activities.
Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan.
Reviews the content and quality of site and central monitoring documentation.
Interacts with the client and other functional departments related to clinical monitoring and site management activities.
Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol.
Oversees CRAs and Central Monitors assigned to the study and assesses compliance.
Provides feedback to line managers on staff performance.
May be assigned to larger, more complex trials.
Qualifications
What we’re looking for
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 achieving project milestones.
Experience working in an international environment.
Expertise in site management and monitoring (clinical or central).
Preferred experience with risk-based monitoring.
Understanding of clinical trial management financial principles and budget management.
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
Good computer skills and communication abilities.
Strong conflict resolution skills.
Ability to apply problem-solving techniques to resolve complex issues.
Moderate travel may be required, approximately 20%.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products.
At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway.
Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most.
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status.
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