Highline Sciences is a specialized, full-service CRO and consultancy founded from within an oncology biotech to provide a better solution for innovative biotech companies. We are purposefully a different type of CRO. We aim to recruit, develop, and retain industry super stars that are curious, passionate, and want to make a difference. We’re looking for people who share our vision and want to contribute their unique skills and experience to a shared mission.

Summary:

Responsible for planning and implementation of clinical operations deliverables, primarily site management and clinical monitoring, of assigned project(s).

Independently serves as Clinical Trial Lead on complex studies, applying and providing guidance to clients and team members on best practices tailored to the applicable project, patient population, investigational product and client. Responsible for coaching/mentoring and supporting the CRA team and representing the clinical operations function to the client.

May have direct line management responsibilities for junior Clinical Operations personnel. May have management responsibilities for Clinical Research Associates. May have department-level responsibilities related to Clinical Operations strategic development and continuous improvement of processes. Serves in a mentorship role with minimal supervision and guidance.

Job Responsibilities:

Lead/Perform independently, with minimal guidance and oversight:Manage clinical operations deliverables including timeline, quality, scope, and financials

• Works closely with the Project Manager to develop plans, monitor resource allocation and ensure that clinical site management and monitoring is being delivered per contract with quality and efficiency
• Proactively identify risks and escalate to Project Manager and other appropriate functional leads
• Together with the Project Manager, ensure transparent communication both internally and externally regarding study progress and issues
• Develop and maintain project-specific clinical operations plans as required per project (e.g. Clinical Monitoring Plan, Cohort
• Management Plan, Recruitment Plan, etc.)
• Develop and maintain project-specific clinical operations reference materials and tools, including study-specific forms and logs
• Develop training materials and conduct training for the clinical operations team throughout the project lifecycle
• Provide operational oversight for site and CRA deliverables and key performance indicators such as site activation, subject recruitment, site monitoring visits, data currency and quality
• Manage CRA resourcing, site assignments, visit schedules and serve as the initial point of contact for clinical operations and monitoring issues
• Review and approve site monitoring visit reports; monitor and track related metrics for compliance with Clinical Monitoring Plan and Highline SOPs
• Conduct monitoring visits, co-monitoring visits, assessment visits and/or team training as necessary
• May have line management responsibilities (including interviewing and selection, terminations, professional development and performance appraisals)
• May have business development responsibilities
• May assist with identification of Clinical Operations Department initiatives and independently work on assigned initiatives

Minimum Qualifications

• Minimum of seven (7) years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience
• Minimum of three (3) year experience as a Clinical Trial Lead or equivalent (Clinical Trial/Study Manager) or relevant clinical operations experience at a CRO, biotech or pharma company
• Or equivalent demonstrated skill set

Plus:

• In-depth knowledge of clinical trials; the ability to see the bigger picture and prioritize the critical elements of success
• Early phase clinical trial experience

Preferred Qualifications

• Prior experience in a Clinical Research Associate related role at a CRO, biotech or pharma company
• Prior experience working on Global clinical trials in a Clinical Operations role

Our core belief is that it’s all about the team.

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