Site Engagement Liaison

We are hiring for Site Care Partner 1:

Location: Mumbai (office-based)

As a Site Care Partner, you will be joining the worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with one of the worlds premier Biopharmaceutical companies. Working across a vast portfolio of medicines and vaccines this company has, over centuries created a strong heritage of delivering innovative treatments and preventive medicines globally.

As a SiteCare Partner, you 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. This role is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies.

What you will be doing:

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.
• 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/planning and site recommendation through intimate understanding of country, sites, processes and practices, and associated site performance metrics.
• 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.
• Deploy 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.
• Confirm (and educate where needed) that sites are familiar with client 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.
• Conduct SIVs if required
• 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 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.

Qualification:

• 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 + 5 years of clinical research experience and/or quality management experience as monitoring CRA.

Prior 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 (preferred)
• Minimum 5 years of On-site monitoring and site management (CRA) experience
• Project management experience preferred in the clinical development area
• Ability to lead, troubleshoot and influence for delivery
• Independent approach

Please reach out at Gayathri.Nareshkumar@iconplc.com