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Site Excellence Partner – Clinical Trials (Pharma)

Job Overview

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The Site Excellence Partner proactively collaborates with key stakeholders and provides local intelligence to country outreach surveys, investigators strategies, and pipeline opportunities. Additionally, the SiteExcellence Partner will help coordinate with other roles and functions that will interface with study sites, thereby, simplifying communications and enhancing overall visibility into and confidence of quality of site-level activities
POSITION RESPONSIBILITIES
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 risk prediction tools and plans (e.g., IQMP, the Site Quality Risk Dashboard) 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 thesite/country level for their studies, including identifications of mitigation and control.

·   Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Central Monitoring signals, Dashboards 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 requirements and standards.

·   Perf orm 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 Monitor or alone depending on the nature of the issue(s).

·   Work with CRO Monitors,  and CRO colleagues as appropriate, to drive resolution of oversight issues.

·   Accountable for identifying site and Monitor 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 with other country colleagues across study & assets in the portfolio to drive accelerated drug delivery.

·   May act as a Subject Matter Expert on  systems and processes

·   Review of monitoring visit reports.

·   Support development and delivery of decentralized capabilities at investigator sites. 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 SiteRelationship Partner and Country Trials Manager if required.

·   Serve as point of contact for quality and safety escalations for CRO, Monitors, Site Relationship Partner, Country Trials Manager and Study Team.

·   Support the resolution of operational obstacles at the site / country level in order toadvance the site and study deliverables. 

EDUCATION AND EXPERIENCE
·       A scientific or technical degree in healthcare · BS/BSc/MS/MSc or equivalent.

·       Extensive knowledge of clinical trial methodology.

·       A minimum of 5 years of clinical research experience.

·       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.

·       Site Management/Monitoring (Monitor) experience.

·       Project management experience preferred in the clinical development area.

 

TECHNICAL SKILLS REQUIREMENTS

Technical skills required and/or preferred, as applicable.

Technical Competencies

·        Demonstrated knowledge of clinical research processes and global and local regulatoryrequirements;

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.

·        Superior technical skills: ability to evaluate, interpret and utilize multiple and varied databases (e.g.,

CTMS, CAL) and systems to proactively manage deliverables and tasks.

 

Behavioral Competencies

·       Considers stakeholders including regulatory agencies and marketing when developing strategiesand f uture 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. 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.

·       Ability to lead, troubleshoot and influence for delivery.

Only equity candidates will be considered for this role.

Send your CV to Vicki@Medicalcareers.co.za

 

 

Only candidates can apply for this job.
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