Site Relationship and Excellence Partner

The Site Relationship and Excellence Partner (SREP) is the main Client point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site and is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies.

Relationship Building and Management

• Ushers investigator sites through site activation and study activities from study start up to close out

• Maintains regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback

• Acts 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

• Follows up and close issue status with investigators to ensure awareness of resolution

• Informs and educates investigator sites of Client pipeline opportunities that may be a good fit

• Acts as the face of Client and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and Client’s reputation is that of Partner of Choice

• Leads effective site recruitment planning and implementation of plans at the country- and site-level, consistent with global plan and local targets

• Demonstrates leadership within the local clinical development environment with a goal to enhance Client reputation in scientific leadership

• Proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and Client pipeline opportunities

• Capable of performing both the Site Excellence Partner and the Site Relationship Partner role as dictated by need

Proactively Providing Local Intelligence

• Provides country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care (SOC) and medical practices

• Provides 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

• Reviews and manage site practices that differ from Client practices and liaise with study teams and study management

• Understands targeted site criteria as well as services delivered to target sites

• Tracks that all such services are provided consistently and in a timely manner

• Recommends potential targeted sites and conduct follow up with those sites as required

Study Start-Up, Activation, and Execution to Plan

• 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 Client communications and

enhancing overall visibility into and confidence of quality of site-level activities

• For Targeted Sites

o Global Site and Study Operations (GSSO) targeted site strategy by qualifying and activating targeted sites, while coordinating Client functions to standardize processes and deliver activation

in line with the targeted site strategy

o Confirms (and educate where needed) that sites are familiar with Client requirements for study start up and facilitate the availability of Master Service Agreements (MSAs) when feasible

o Leads study start up activities at the site level, including management of issues that may compromise time to site activation

o Closely monitors and supports 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

o Provides enrollment support and ensures 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

o Maintains a thorough knowledge of assigned protocols

o Proactively identifies, manages and escalates site issues related to study delivery, triaging and coordinating communications and resolution efforts by Client colleagues

o Supports database release by facilitating query resolution, as needed

Protocol Site Oversight

• Maintains a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality

• Attends Investigator meeting/protocol training to ensure clearunderstanding of the protocol requirements

CRO and Study Management Interface

• Supports 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

Site and Study Management Interface

• Supports local Investigator relationship management with the Site Relationship Partner

• Serves as point of contact for quality and safety escalations for CRO, CRAs, Site Relationship Partner and Study Team

• Supports the resolution of operational obstacles at the site/country level in order to advance the site and study deliverables

Process, Standards, and Oversight

• Responsible for site and monitoring quality, regulatory and Good Clinical Practice (GCP) compliance

• Drives inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution

• Follows 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 proactively identify risks

• Leads risk assessment at the site/country level for their studies, including identifications of mitigation and control

• Maintains knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.)

• Demonstrates use of data to enhance quality and accelerate study delivery

• Applies knowledge of data and analytics to target site and study, recommend and implement actions for mitigation and control

• Conducts and report oversight activities, both remote and onsite visits, according to Client requirements and standards

• Performs 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)

• Works with CRO CRAs, and other CRO colleagues, to drive resolution of oversight issues

• Identifies site and CRA performance issues and quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of Corrective and Preventative Actions (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

• Identifies potential improvements for Client processes

• Reviews monitoring visit reports

• Utilizes and interprets 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

Skills:

• Skills in more than one language are an advantage in this role; English is required

• Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance

(preferred)

• Ability to lead, troubleshoot and influence for delivery

• Independent approach

• 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

• Effective verbal and written communication skills in relating to colleagues and associates both inside