Site Excellence Partner (FSP) - 0.5 FTE

Position Purpose:

The Site Excellence Partner (SEP) is accountable for safeguarding the quality and patient safety at the investigator site and is responsible for site and monitoring oversight

The SEP is responsible for utilizing and interpreting 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

The SEP is accountable for identifying Clinical Research Associate (CRA) performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place

The SEP may be required to support some or all of the primary responsibilities of the Site Relationship Partner (SRP), as example, proactively collaborating and providing local intelligence to country outreach surveys, targeted sites strategies, study design, and Client pipeline opportunities

The SEP may be required to support additional primary responsibilities of the SRP in study start up, activation, and execution to the plan for targeted sites, helping 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

Primary Duties:

Responsible for process, standards and oversight for assigned studies

Responsible for site and monitoring quality, regulatory and Good Clinical Practice (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 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 Client 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 Provider CRAs, and other Provider 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 Client processes

Review of monitoring visit reports

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

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 Provider, 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

General

Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training

Adhere to EP and Client SOPs and processes

The Individual:

A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology

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

Demonstrated knowledge of clinical research processes and global and local regulatory requirements; ability to gain command of process details

Demonstrated ability to work in cross-functional matrix environment

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 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

Builds wide networks and alliances; utilizes stakeholder input to develop strategic thinking and find opportunities for collaboration

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 enthusiasm

Availability to travel regularly within country and region is required

Fluent English

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