Job Responsibilities

The Sr Professional Quality Management will:

• Support Clinical Monitoring (CM) teams through site audits
• Work with CM teams to prepare for site audits, including quality checks on training documentation, TMF, and study documents
• Assist CM teams during audits and inspections to determine underlying issues, perform root cause analysis, and formulate corrective and preventative actions
• Provide quality support and consultancy for Quality Management and Operations
• Ensure commitments and timelines for assigned activities adhere to Syneos Health and customer requirements
• Offer solutions to process and quality-related issues and identify process improvement opportunities
• Serve as a key resource within a business area or discipline

Qualifications

• BA/BS degree in science or healthcare or equivalent education and experience
• Experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and/or Good Manufacturing Practice (GMP)
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
• Strong organizational, interpersonal, and team-oriented skills
• Ability to act independently and proactively
• Significant project management and customer management skills

Additional Information

Travel may be required (approximately 15%).

Job Data by YubHub.

Responsibilities:

• Activate sites for clinical trials by conducting site qualification visits, training, and equipment setup
• Ensure sites are compliant with GCP and regulatory requirements
• Collaborate with cross-functional teams, including study managers, monitors, and data coordinators
• Develop and maintain relationships with site staff and investigators
• Analyze site performance data to identify trends and areas for improvement

Requirements:

• Bachelor's degree in a related field (e.g., life sciences, nursing)
• 1-2 years of experience in clinical research or a related field
• Strong knowledge of GCP, regulatory requirements, and clinical trial operations
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team

Syneos Health offers a range of benefits, including career development opportunities, technical and therapeutic area training, peer recognition, and total rewards programs.

Job Data by YubHub.

Responsibilities:

• Manage clinical trials from initiation to close-out
• Ensure compliance with regulations, GCP, and protocol
• Coordinate with cross-functional teams, including investigators, research subjects, and client teams
• Develop and implement risk mitigation strategies
• Oversee site management, clinical monitoring, and central monitoring deliverables
• Review and provide feedback on study plans, budgets, and protocols
• Identify and escalate risks to clinical trial management deliverables
• Collaborate with other functional leaders to coordinate delivery handoffs and meet study milestones
• Develop and maintain clinical study tools and templates
• Provide training to study teams on protocol specifics, CRF completion, and Sponsor SOPs
• Oversee resourcing allocations for CRAs and Central Monitors
• Ensure quality of clinical monitoring, central monitoring, and site management deliverables
• Review project oversight dashboards and clinical trial systems to ensure data accuracy and timeliness

Requirements:

• Bachelor's degree or RN in a related field or equivalent 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)
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Strong communication, presentation, and interpersonal skills
• Ability to apply problem-solving techniques to resolve complex issues
• Moderate travel required (approximately 20%)

Job Data by YubHub.

Responsibilities:

• Oversee and manage site solutions projects, ensuring they are delivered on time, within budget, and to the required quality standards
• Liaise with clients, sites, and internal stakeholders to resolve issues and ensure project success
• Develop and implement project plans, budgets, and resource allocation strategies
• Manage project finances, including budgeting, forecasting, and invoicing
• Ensure compliance with relevant regulations, SOPs, and GCP guidelines
• Build and maintain strong relationships with site stakeholders and sponsors
• Provide input to corrective and preventive actions related to quality issues
• Support the development of site relationships and future horizon planning for site solutions and optimization strategies
• Collaborate with study teams to define and lead site engagement and contracting processes
• Lead site solutions-related resource management, including requesting site-level resources and communicating changes to resource requirements
• Act as a company champion for site and sponsor clients
• Support the delivery and implementation of site solutions initiatives

Additional Information: The company reserves the right to assign other tasks, duties, and responsibilities. Equivalent experience, skills, and/or education will be considered.

Job Data by YubHub.

Job Responsibilities

• Lead multi-country projects, including negotiating and preparing contracts, budgets, and related documents
• Produce site-specific contracts from country clinical trial agreement (CTA) template
• Negotiate budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor
• Perform quality control and arrange execution of CTAs
• Administer all contract management processes
• Generate amended contract and/or budget documents as necessary
• Work closely with Site Contract Service Center and Legal to harmonize site contract
• Identify possible contract or process operational risk and provide solutions
• Provide support to business development and represent site contracts/Site Start-Up (SSU) at internal or customer meetings
• Collaborate with internal and external legal, finance, and clinical operations departments
• Maintain and actively support review and development of contract templates, budget templates, and site-specific files and databases
• Serve as key communication liaison between site contracts staff and internal and external customers
• Train and mentor less experienced staff members on departmental Standard Operating Procedures (SOPs)

Qualifications

• BA/BS degree in Business Administration, Public Administration, Public Health, or related field
• Moderate contracts management experience in a contract research organization or pharmaceutical industry
• Strong knowledge of the clinical development process and legal and contracting parameters
• Strong computer skills in Microsoft Office Suite
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
• Good understanding of clinical protocols and associated study specifications
• Excellent communication, presentation, and interpersonal skills
• Strong negotiating skills and problem-solving skills
• Ability to mentor and motivate more junior staff

What We Offer

Syneos Health offers a dynamic and supportive work environment, opportunities for career development and progression, and a comprehensive total rewards program.

Job Data by YubHub.