Clinical Site Operations Manager (remote-based)

An excellent opportunity has opened up for a Clinical Site Operations Manager to join a CRO organisation who focus on helping patients by improving their health through the delivery of therapies.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will maintain consistent communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
• To be the point of contact for all site- and study-level questions, liaising with and escalating to appropriate teams to respond and resolve questions. Follow up and close issue status with investigators to ensure awareness of resolution.
• To support investigator sites through site activation and study activities from study start up to close out.
• Inform and educate investigator sites of pipeline opportunities that may be a good fit.
• 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.
• You will be responsible for relationship building and management.
• 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.
• Review and manage site practices that differ from practices and liaise with study teams and study management.
• 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.
• Recommend potential targeted sites and conduct follow up with those sites as required. 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 functions to standardize processes and deliver activation in line with the targeted site strategy.
• Confirm that sites are familiar with 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.
• Closely monitor and support study start up activities including review of key documents to address regulatory and/or ethics committee questions for targeted sites.

Key Skills:

• Ability to communicate effectively and appropriately with internal & external stakeholders.
• Demonstrated success in prior scientific/technical/administrative roles.
• Demonstrated experience in site activation.
• Demonstrated networking and relationship building skills.
• Demonstrated ability to manage projects and cross-functional processes.

Requirements:

• Experience implementing centrally designed and developed initiatives on a local basis Technical Competencies.
• The ideal candidate will have experience with drug development and monitoring (preferred).
• Demonstrated knowledge of quality and regulatory requirements for applicable countries.
• Demonstrated knowledge of site intelligence at country/cluster level in support of site recommendation.
• Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.