Site Care Partner 1
Location: Mumbai (office-based)
As a Site Care Partner, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
You will be partnering with one of the world’s 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.
Responsible for proactively providing local intelligence
- 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.
Accountable for study start-up, activation, and execution to plan
For targeted sites:
- 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 process, standards, and oversight
- 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.
You are:
- Training and Education
- 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
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
