Responsibilities:

• Responsible for site management oversight, clinical monitoring, and central monitoring deliverables
• Oversees site interactions post-activation through site closeout
• 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
• 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
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations
• Participates and presents in key meetings
• 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
• Responsible for development and ongoing maintenance of clinical study tools and templates
• Coordinates initial and ongoing training to the study team
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments, and study team members' conduct
• Ensures quality of the clinical monitoring, central monitoring, and site management deliverables
• Reviews the project oversight dashboards and other clinical trial systems
• 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, 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 routinely assesses study-specific process and training compliance
• Provides feedback to line managers on staff performance

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
• Demonstrates understanding of clinical trial management financial principles and budget management
• 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 to resolve complex issues
• Moderate travel may be required, approximately 20%

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The successful candidate will provide independent resource solution management for one or more resource subsets/roles, conduct meetings with internal stakeholders, and support demand planning processes and resource requirements.

Key responsibilities include:

• Managing and supporting resource requirements for various Business Units
• Analyzing resource assignments, skillsets, and availability to support recommendations for potential assignment opportunities
• Ensuring data integrity in global resourcing tools and updating trackers
• Supporting centralized resourcing efforts and internal stakeholders
• Evaluating complex cross-resourcing requests and reporting potential solution options
• Establishing partnerships with key business liaisons and ensuring communication and sharing of information
• Reviewing and analyzing reports to provide resourcing trends and challenge data integrity
• Providing continuous process improvement suggestions and escalating resourcing or process issues as required

The ideal candidate will have:

• A BA/BS degree in business, management, or a science/health care field
• Resource management experience, preferably in a contract research organization, pharmaceutical, or biotechnology company
• Direct and relevant clinical research experience preferred
• Excellent computer skills in Word, Excel, PowerPoint, Email, and Internet
• Ability to handle multiple tasks and meet deadlines while delivering high-quality work in a dynamic environment

Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.

The company is committed to building an inclusive culture where employees can authentically be themselves.

Job Data by YubHub.

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

Key responsibilities include:

• Evaluating site performance and providing recommendations for site-specific actions
• Verifying informed consent and protecting patient confidentiality
• Assessing site processes and conducting source document reviews
• Resolving queries and providing guidance to site staff
• Managing investigational product inventory and verifying dispensing and administration
• Reviewing investigator site files and trial master files
• Documenting activities and supporting subject recruitment and retention
• Collaborating with project teams and site personnel

Requirements:

• Bachelor's degree or RN in a related field
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to manage required travel of up to 75%

Syneos Health offers a dynamic work environment, opportunities for career development, and a Total Self culture that encourages authenticity and well-being.

Job Data by YubHub.

As a CRA, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Key responsibilities include:

• Evaluating the overall performance of site and site staff, and providing recommendations regarding site-specific actions
• Verifying the process of obtaining informed consent has been adequately performed and documented for each subject/patient
• Assessing factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
• Conducting Source Document Review of appropriate site source documents and medical records
• Verifying required clinical data entered in the case report form (CRF) is accurate and complete
• Applying query resolution techniques remotely and on site, and providing guidance to site staff as necessary
• Utilizing available hardware and software to support the effective conduct of the clinical project data review and capture
• May perform investigational product (IP) inventory, reconciliation, and reviews storage and security
• Routinely reviewing the Investigator Site File (ISF) for accuracy, timeliness, and completeness
• Documenting activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
• Supporting subject/patient recruitment, retention, and awareness strategies
• Entering data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution

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.