Site Relationship & Excellence Partner at Syneos Health Clinical Solutions

Site Relationship & Excellence Partner 

Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.

For our client, a global pharmaceutical organization we are currently looking for a Site Relationship & Excellence Partner. In this role you will be working from the Client’s office.

• The Site Relationship & Excellence Partner is the main point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site.
• This role is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies. As part of the oversight responsibilities, this role will utilize and interpret data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.
• This role is also accountable for identifying CRA performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place.
• The Site Relationship & Excellence Partner is the “face of the Sponsor” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and our client’s reputation is that of “Partner of Choice.”
• The Site Relationship & Excellence Partner proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and pipeline opportunities.
• This role is accountable for study start up, activation, and execution to the plan for targeted sites.
• In addition to being the main point of contact, the lead will help coordinate with other roles and functions that will interface with target sites, thereby, simplifying site Sponsor communications and enhancing overall visibility into and confidence of quality of site-level activities.

Responsible for relationship building and management

• Usher investigator sites through site activation and study activities from study start up to close out.
• Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
• Act as the main point of contact for all site- and study-level questions, liaising with and escalating to appropriate teams to respond and resolve questions. Follow up and close issue status with investigators to ensure awareness of resolution.
• Inform and educate investigator sites of the sponsor’s pipeline opportunities that may be a good fit.
• Lead effective site recruitment planning and implementation of plans at the country- and site-level, consistent with global plan and local targets.
• Demonstrate leadership within the local clinical development environment with a goal to enhance the Sponsor reputation in scientific leadership.

Responsible for proactively providing local intelligence

• Provide country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices.
• Provide country/regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required. Apply clinical development strategy in the assessment of country and site selection at the asset level.
• Provide country/regional level input to country strategy/planning and site recommendation through intimate understanding of country, sites, processes and practices, and associated site performance metrics.
• Provide input to cluster level intelligence for site strategy and support implementation of cluster-level strategy.
• Review and manage site practices that differ from the sponsor’s practices and liaise with study teams and study management.
• Understand targeted site criteria as well as services delivered to target sites. Track that all such services are provided consistently and in a timely manner.
• Recommend potential targeted sites and conduct follow up with those sites as required.
• Develop a solid understanding of targeted site-specific/institution-specific requirements to apply this knowledge to future site activities or the development of new targeted site relationships.

Accountable for study start-up, activation, and execution to plan
For Targeted Sites

• Deploy GSSO targeted site strategy by qualifying and activating targeted sites, while coordinating Sponsor’s functions to standardize processes and deliver activation in line with the targeted site strategy.
• Confirm (and educate where needed) that sites are familiar with Sponsor’s requirements for study start up and facilitate the availability of MSAs when feasible.
• Lead study start up activities at the site level, including management of issues that may compromise time to site activation.
• Closely monitor and support study start up activities including review of key documents (e.g., local Informed Consent Document template), to address regulatory and/or ethics committee questions for targeted sites.

For All Sites

• Provide enrollment support and ensure progress by responding to start up and recruitment issues from investigators, partner with study team to define and support recruitment initiatives at site / country level.
• Maintain a thorough knowledge of assigned protocols.
• Proactively identify, manage and escalate site issues related to study delivery, triaging and coordinating communications and resolution efforts by Sponsor’s colleagues.
• Support database release by facilitating query resolution, as needed.
• Actively pursue possible efficiencies and develop best practices in the delivery activities for site start up and performance at the targeted site level to increase investigator/site satisfaction and strengthen targeted site relationships with the Sponsor.
• Seek assignment to complex protocols due to demonstrated capability in responsibilities.

Responsible for CRO and Study Management Interface

• Support local CRO representatives develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Site Excellence Partner and Study Management.

Responsible For Process, Standards, And Oversight

• Responsible for site and monitoring quality, regulatory and GCP compliance.
• Drive inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution.
• Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
• Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation Leads in conjunction with local country intelligence to to proactively identify risks. Lead risk assessment at the site/country level for their studies, including identifications of mitigation and control.
• Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.). Demonstrate use of data to enhance quality and accelerate study delivery.
• Apply knowledge of data and analytics to target site and study, recommend and implement actions for mitigation and control.
• Conduct and report oversight activities, both remote and onsite visits, according to the Sponsors requirements and standards.
• Perform additional oversight visits/reviews based on the type of issues that arise during the course of a study, and the analytics and visualizations outputs. These may be conducted with the assigned CRA or alone depending on the nature of the issue(s).
• Work with CRO CRAs, and other CRO colleagues as appropriate, to drive resolution of oversight issues.
• Accountable for identifying site and CRA performance issues and quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of CAPAs to address these.
• Demonstrates the learning culture by ensuring site quality and trends, including preventive actions are shared across study & assets in the portfolio to drive accelerated drug delivery.
• Identify potential improvements for internal processes.
• Review of monitoring visit reports.
• Serve as key contributor to process improvement initiatives and may lead local area initiatives.
• Support in external environment shaping activities for a country.
• Act as a Subject Matter Expert for a category or global processes within the GSSO organization.
• Support onboarding of new colleagues in country.

Protocol Site Oversight

• Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality.
• Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements.
• Seek assignment to complex protocols driven by demonstrated capability in role.

Site and Study Management Interface

• Support local Investigator relationship management with the Site Relationship Partner.
• Serve as point of contact for quality and safety escalations for CRO, CRAs, Site Relationship Partner and Study Team.
• Support the resolution of operational obstacles at the site / country level in order to advance the site and study deliverables.
• Support vendor relationship management at country-level.

The Site Relationship and Excellence Partner should be capable of performing both the Site Excellence Partner and Site Relationship Partner roles as dictated by need.

We are looking for an enthusiastic colleague with the following:
Training and Education

• A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/experience: BS/BSc/MS/MSc or equivalent + 7 years of clinical research experience and/or quality management experience.
• Skills in more than one language are an advantage in this role. English is required.

Prior Experience

• Experience implementing centrally designed and developed initiatives on a local basis
• Solid knowledge of clinical development processes with strong emphasis on monitoring
• Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred)
• Site Management/Monitoring (CRA) experience (preferred)
• Project management experience preferred in the clinical development area
• Ability to lead, troubleshoot and influence for delivery
• Independent approach

Technical Competencies

• Demonstrated knowledge of quality and regulatory requirements for applicable countries
• Demonstrated knowledge of site intelligence at country/cluster level in support of site recommendation
• Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment
• Demonstrated success in prior scientific/technical/administrative roles
• Demonstrated experience in site activation
• Demonstrated networking and relationship building skills
• Demonstrated ability to manage projects and cross-functional processes
• Ability to communicate effectively and appropriately with internal & external stakeholders
• Ability to adapt to changing technologies and processes
• Ability to evaluate, interpret and present complex issues and data to support assessment and mitigation of site risk

Behavioral Competencies

• Seeks to develop an integrated view of key colleague issues to shape decisions and strategy development
• Proactively manages change by identifying opportunities and coaching self and others through the change
• Demonstrated ability to introduce new ideas and implement them
• Effectively overcoming barriers encountered during the implementation of new processes and systems
• Identifies and builds effective relationships with customers and other stakeholders
• Builds wide networks and alliances; utilizes stakeholder input to develop strategic thinking and find opportunities for collaboration
• Works well across country boundaries, respecting communication and cultural differences in interpersonal relationships
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
• Considers stakeholders including regulatory agencies and marketing when developing strategies and future directions
• Challenges people to surpass themselves in reaching their objectives using innovative solutions
• Utilizes and encourages innovative approaches to build and maintain a competitive advantage
• Acts as a champion of change across the area/region/countries; uses facts, logic and personal credibility to influence the successful implementation of process improvements
• Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards
• Exhibits behaviors consistent with company values to colleagues at multiple locations with diverse cultures
• Motivates through example, commitment, loyalty and enthusiast

About Us

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform.