Clinical Trial Manager

hace 3 semanas

Colombia Syneos Health, Inc. A tiempo completo
Clinical Trial Manager - Sponsor Dedicated

About the Role

Syneos Health is seeking a Clinical Trial Manager - Sponsor Dedicated to join our team. As a Clinical Trial Manager, you will be responsible for site management oversight, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.

Key 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, investigator payments, and other related activities.
  • May be responsible for identifying 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/Central Monitors) 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.
  • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment, and Data Management to coordinate delivery handoffs and meet expected study milestones.
  • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
  • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans, and guidelines, data plans, and timelines for the study.
  • Ensures quality of the clinical monitoring, central monitoring, and site management deliverables within a project.
  • Reviews the project oversight dashboards and other clinical trial systems to oversee site and patient activities.
  • Understands the monitoring strategy required for the study and, where required, 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, central monitoring, and site management activities.
  • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP, and country regulations.
  • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance.
  • Provides feedback to line managers on staff performance, including strengths and areas for development.

Requirements

What We're Looking For

  • Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
  • Ability to lead and align teams in the achievement of project milestones.
  • Capable of working in an international environment.
  • Previous clinical trial experience in site management.
  • Preferred experience with risk-based monitoring and clinical or central monitoring.
  • Familiar with financial principles and budget management practices.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Must demonstrate good computer skills.
  • Good communication, presentation, and interpersonal skills among project team and with sites.
  • Basic conflict resolution skills.
  • Ability to apply problem-solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
  • Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
  • Moderate travel may be required, approximately 20%.

About Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

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.

  • Clinical Trial Lead

    hace 2 semanas

    Colombia Syneos Health, Inc. A tiempo completo

    Clinical Trial Manager Job DescriptionSyneos Health, Inc. is seeking a dedicated Clinical Trial Manager to join our team in Colombia. This is a Sponsor dedicated role that requires a strong understanding of clinical trial management principles and practices.Key Responsibilities:Oversee site management, clinical monitoring, and central monitoring deliverables...

  • Clinical Trial Manager

    hace 3 semanas

    Colombia Syneos Health, Inc. A tiempo completo

    Clinical Trial Manager Job DescriptionSyneos Health, Inc. is seeking a skilled Clinical Trial Manager to oversee site management, clinical monitoring, and central monitoring deliverables. The ideal candidate will have a strong background in clinical trials, with experience in site management and risk-based monitoring.Key Responsibilities:Manage site...

  • Clinical Trial Manager

    hace 2 semanas

    Colombia Syneos Health, Inc. A tiempo completo

    Clinical Trial Manager - Sponsor DedicatedJob SummarySyneos Health, Inc. is seeking a Clinical Trial Manager - Sponsor Dedicated to join our team. As a Clinical Trial Manager, you will be responsible for site management oversight, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and...

  • Senior Clinical Trial Manager, Oncology, Colombia

    hace 5 meses

    Colombia Novasyte A tiempo completo

    Required: 3+ years of Clinical Trial Management experience (CRO experience preferred). Experience managing clinical trials in LATAM and North America required Oncology experience related to managing studies Fluent in English, both writing and verbally Preferred: Experience managing global studies Experience managing studies in other therapeutic areas...

  • Clinical Trial Manager

    hace 1 mes

    Colombia, Huila ICON A tiempo completo

    As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives. Working in this program you will feel challenged and...

  • Clinical Trial Manager

    hace 1 mes

    Colombia ENGINEERINGUK A tiempo completo

    As a Clinical Trial Manager, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people's lives. Working in this program you will feel challenged...

  • Clinical Trial Manager

    hace 4 semanas

    Colombia ENGINEERINGUK A tiempo completo

    As a Clinical Trial Manager, you will be joining the world's largest and most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people's lives. Working in this program, you will feel...

  • Clinical Trial Manager

    hace 3 semanas

    Colombia Syneos Health, Inc. A tiempo completo

    Clinical Trial Manager - Sponsor dedicated - Colombia Client Based Updated: October 21, 2024 Location: Colombia-Latin America - COL-Colombia-Client-Based Job ID: 24005643 Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and...

  • Clinical Research Manager

    hace 4 semanas

    Colombia ENGINEERINGUK A tiempo completo

    As a Clinical Trial Manager at ICON, you will be part of a global team that is dedicated to delivering high-quality clinical research solutions. Your primary responsibility will be to oversee the planning, management, and execution of clinical studies in accordance with the company's global program strategy.Key responsibilities include:Leading...

  • Clinical Research Manager

    hace 1 mes

    Colombia ENGINEERINGUK A tiempo completo

    Job Title: Clinical Trial ManagerAs a Clinical Trial Manager at ENGINEERINGUK, you will be part of a global clinical research organization that is powered by healthcare intelligence. You will be working with a pharmaceutical company that is committed to discovering and developing treatments that improve and save people's lives.Key Responsibilities:Plan,...

  • Clinical Research Manager

    hace 3 semanas

    Colombia ENGINEERINGUK A tiempo completo

    Job SummaryAs a Clinical Trial Manager, you will be responsible for overseeing the execution of clinical studies in accordance with the global program strategy. This role involves leading cross-functional teams, developing program-specific materials, and ensuring timely delivery of study-specific deliverables.Key ResponsibilitiesPlan, manage, and oversee...

  • Clinical Operations Manager

    hace 1 mes

    Colombia destinationone Consulting A tiempo completo

    destinationone Consulting specializes in recruitment across diverse sectors, including Healthcare, Health Tech, Government, Municipalities, Non-Profits, Legal, Public Accounting, Food and more. We are proactively building a data bank for opportunities in these fields. By applying, you ensure our recruiters can quickly match you with suitable roles when they...

  • Principal Clinical Research Associate

    hace 4 semanas

    Colombia ICON A tiempo completo

    Job Title: Principal Clinical Research AssociateAs a Principal Clinical Research Associate at ICON, you will be part of a global team that is dedicated to advancing the field of clinical research. We are seeking a highly experienced and skilled professional to join our team and contribute to the success of our clients.Key Responsibilities:Manage and...

  • Clinical Research Director

    hace 5 días

    Colombia ICON A tiempo completo

    Job SummaryAs a Principal CRA at ICON, you will be responsible for managing clinical trials and ensuring the accuracy and completeness of data entered into systems.You will be working with a pharmaceutical company committed to discovering and developing treatments that improve and save people's lives.Key ResponsibilitiesMaintain timelines and ensure accuracy...

  • Ssu & Regulatory Specialist Ii/ Colombia Client

    hace 5 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Site Start-Up & Regulatory Specialist II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical...

  • Clinical Operations Director

    hace 4 semanas

    Colombia destinationone Consulting A tiempo completo

    Job Title: Clinical Operations ManagerDestinationone Consulting is seeking a seasoned Clinical Operations Manager to oversee the daily clinical activities of our healthcare practice. As a key member of our team, you will be responsible for ensuring high-quality patient care while optimizing operational efficiency.Key Responsibilities:Lead a team of clinical...

  • Clinical Data Reviewer

    hace 5 meses

    Colombia, Huila ICON A tiempo completo

    As a Clinical Date Reviewer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - Serve as a Clinical Data Reviewer and identify any errors in data by performing data review that require further clarification with the study sites - Perform ongoing...

  • Senior Clinical Research Manager

    hace 23 horas

    Colombia ENGINEERINGUK A tiempo completo

    Job DescriptionWe are seeking a seasoned Clinical Research Director to join our Engineering UK team. This role offers the opportunity to lead clinical research projects from start to finish, ensuring timely delivery and high-quality results.Key ResponsibilitiesMaintain project timelines and ensure accuracy and completeness of data entry into...

  • Senior Clinical Research Associate

    hace 2 semanas

    Colombia ENGINEERINGUK A tiempo completo

    As a Senior Clinical Research Associate at ENGINEERINGUK, you will be part of the world's largest and most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people's lives. Working in this program, you...

  • Sr Cra I with Oncology Experience

    hace 5 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Senior Clinical Research Associate I with oncology experience - Home Based Colombia** 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...