The Clinical Trial Manager II - Sponsor Dedicated is 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:

• Oversees site interactions post-activation through site closeout, including patient recruitment, investigator payments, and other related activities
• Identifies critical data and processes, protocol execution risks, and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT)
• Reviews study scope of work, budget, and protocol content to ensure clinical project team awareness of contractual obligations and parameters
• 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 in key meetings, such as Kick Off Meetings, and serves as an escalation point for communications with investigator site staff
• Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones
• Develops and maintains clinical study tools and templates, including the Clinical Monitoring Plan
• Coordinates training to the study team regarding protocol specificities, Case Report Form (CRF) completion, and Sponsor Standard Operating Procedures (SOPs)
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments, and study team members' conduct
• Ensures quality of clinical monitoring, central monitoring, and site management deliverables
• Reviews project oversight dashboards and other clinical trial systems to oversee site and patient activities, study team conduct, and data updates
• Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan
• Reviews content and quality of site and central monitoring documentation
• Interacts with clients and other functional departments related to clinical monitoring, central monitoring, and site management activities and deliverables
• 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 assesses study-specific process and training compliance
• Provides feedback to line managers on staff performance

Requirements:

• 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 (clinical or central)
• Preferred experience with risk-based monitoring
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills
• Good communication, presentation, and interpersonal skills
• Strong conflict resolution skills
• Demonstrated ability to apply problem-solving techniques to resolve complex issues
• Critical thinking to determine the cause and appropriate solution in the identification of issues
• Moderate travel may be required, approximately 20%

Job Data by YubHub.

As a CRA II, you will conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices. You will review study protocols, informed consent forms, and case report forms.

Key responsibilities include:

• Developing and implementing tools, procedures, and processes to ensure quality monitoring
• Contributing to the design, implementation, and delivery of processes, programs, and policies
• Managing defined components of projects or processes within the area of responsibility
• Ensuring accurate and timely documentation of monitoring activities and findings
• Collaborating with cross-functional teams to support clinical trial operations

Requirements:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Preferred certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification

Necessary skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

As a Sr CRA I, you will conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices. You will verify the accuracy and completeness of data collected and ensure adherence to study protocols.

Key responsibilities include:

• Developing and implementing tools, procedures, and processes to ensure quality monitoring
• Contributing to the design, implementation, and delivery of processes, programs, and policies
• Managing and directing the work of lower-level professionals or managing processes and programs
• Ensuring accurate and timely documentation and reporting of clinical trial data
• Collaborating with cross-functional teams to support clinical trial activities
• Identifying and resolving issues related to clinical trial conduct and data integrity
• Providing training and mentorship to junior staff members

Requirements:

• Bachelor's degree in a related field
• Minimum of 3-5 years of experience in clinical research or a related field
• In-depth knowledge of clinical trial processes and regulations
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team

Preferred certifications:

• Certified Clinical Research Professional (CCRP) or equivalent certification

Necessary skills:

• Proficiency in clinical trial management systems and software
• Strong organizational and time management skills
• Attention to detail and accuracy
• Ability to manage multiple projects and priorities simultaneously
• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements

Job Data by YubHub.

The successful candidate will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits, ensuring regulatory, ICH-GCP, and protocol compliance.

Responsibilities:

• Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
• Evaluate overall performance of site and site staff, providing recommendations regarding site-specific actions
• Verify process of obtaining informed consent has been adequately performed and documented for each subject/patient
• Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
• Conduct Source Document Review of site source documents and medical records
• Verify required clinical data entered in the case report form (CRF) is accurate and complete
• Apply query resolution techniques remotely and on site
• Utilize available hardware and software to support effective conduct of clinical study data review and capture
• May perform investigational product (IP) inventory, reconciliation, and reviews storage and security
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
• Support subject/patient recruitment, retention, and awareness strategies
• Enter data into tracking systems as required
• Understand project scope, budgets, and timelines; manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met
• May act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate
• Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings
• Provide guidance at the site and project level towards audit readiness standards
• Maintain working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills and ability to adapt to new technologies
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

Job Data by YubHub.

The successful candidate will be responsible for:

• Site management oversight, including site interactions post-activation and site closeout
• Clinical monitoring and central monitoring deliverables
• Identification of critical data and processes, protocol execution risks, and risk mitigations
• Review of study scope of work, budget, and protocol content
• Collaboration with cross-functional teams, including CRAs, Central Monitors, and Study Start Up
• Strategic thinking and problem-solving to propose and implement risk mitigations
• Participation in key meetings, such as Kick Off Meetings
• Escalation point for communications with investigator site staff
• Development and maintenance of clinical study tools and templates
• Coordination of training for the study team
• Oversight of resourcing allocations for CRAs and Central Monitors
• Review of project oversight dashboards and clinical trial systems

The ideal candidate will have:

• A Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Demonstrated expertise in site management and monitoring (clinical or central)
• 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
• Strong communication, presentation, and interpersonal skills
• Conflict resolution skills
• Critical thinking and problem-solving skills

Benefits of working at Syneos Health include:

• Career development and progression opportunities
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Inclusive culture

Job Data by YubHub.