Apply now
Jefferson Wells
Jefferson Wells

Site Relationship & Excellence Partner consultant

Published on Jobat.be 15 days ago

Site Relationship & Excellence Partner consultant

Our partner innovates to bring treatments to patients that significantly improve their lives. Together with the government and other health partners, they work on high-quality, affordable and accessible healthcare.?

Job description

The Site Relationship & Excellence Partner consultant will be the main point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site. The consultant 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, the consultant 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.

 

SCOPE OF WORK:

  • 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.
    - Lead effective site recruitment planning and implementation of plans at the country- and site-level, consistent with global plan and local targets.
    - …
  • Responsible for proactively providing local intelligence:
    - Provide country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices.
    - 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.
    - 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:
    - Lead study start up activities at the site level, including management of issues that may compromise time to site activation.
    - Deploy GSSO targeted site strategy by qualifying and activating targeted sites, while coordinating functions to standardize processes and deliver activation in line with the targeted site strategy.
    - …
  • 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.
    - Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
    - 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.
    - …
  • Protocol Site Oversight:
    - Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements.
  • Site and Study Management Interface:
    - Serve as point of contact for quality and safety escalations for CRO, CRAs, Site Relationship Partner and Study Team.

Profile

You have a scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology. You have 7 years of clinical research experience and/or quality management experience. Solid knowledge of clinical development processes with strong emphasis on monitoring. Project management experience preferred in the clinical development area. You have the ability to adapt to changing technologies and processes. Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization. You have a fluent English skills written and spoken with an intermediate knowledge level in French and Dutch is required

Offer

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education

Calculate your travel time
To
Jefferson Wells | Elsene 1050

This address could not be found.

We could not find a route between the two addresses.

The exact address for this job is not available. The calculated travel time may differ in reality.
Others also viewed
    Add your CV
    Jobs for you will suggest better jobs based on your education, skills and work experience.

    The job was saved

    You can find your saved jobs on the homepage or in My Jobat.

    To view them on other devices as well, just log in.

    13 days left to apply

    Characteristics

    Requirements

    • Professional bachelor (Higher Education Short Type)
    • Dutch

    Offer

    • Fixed-term
    • Independent
    • Full-time
    • Company car

    Apply before

    • 25 May

    Receive jobs by e-mail

    Receive new 'Production responsible' jobs in Brussels straight to your mailbox.