Clinical Study Manager - LanceSoft Inc
Durham, NC 12460-0070
About the Job
Position: Clinical Study Manager
Duration: 6 Months (potential for extension and/or conversion to perm)
Location: Durham, NC 12460/ Remote Role
Role Summary:
We are offering an outstanding opportunity for a talented person as Clinical Study Manager. As a Clinical Study Manager, you will play a pivotal part in oversight of current early-stage clinical studies and in planning future clinical research studies. This role is ideally based in the US as a home-based worker, and reports directly to the Global Director of Clinical Operations.
Job Purpose:
As our Clinical Study Manager, you are accountable to ensure that the study team is planning and executing the study according to time, budget, quality and as defined in the study management plan, in the study protocol, and in adherence with FDA & ICH-GCP regulatory requirements. You will coordinate with support vendors, CROs, and other partners to ensure efficient execution of the clinical studies. Additionally, you will be accountable to the study-specific goals and internal stakeholders.
Key responsibilities
Basic Requirements:
Duration: 6 Months (potential for extension and/or conversion to perm)
Location: Durham, NC 12460/ Remote Role
Role Summary:
We are offering an outstanding opportunity for a talented person as Clinical Study Manager. As a Clinical Study Manager, you will play a pivotal part in oversight of current early-stage clinical studies and in planning future clinical research studies. This role is ideally based in the US as a home-based worker, and reports directly to the Global Director of Clinical Operations.
Job Purpose:
As our Clinical Study Manager, you are accountable to ensure that the study team is planning and executing the study according to time, budget, quality and as defined in the study management plan, in the study protocol, and in adherence with FDA & ICH-GCP regulatory requirements. You will coordinate with support vendors, CROs, and other partners to ensure efficient execution of the clinical studies. Additionally, you will be accountable to the study-specific goals and internal stakeholders.
Key responsibilities
- Ensures study oversight, delivery of the study on time, according to budget and with quality, using a risk-based approach.
- Leads and oversees operational activities and study execution by building relationships with vendors, sites, and other key stakeholders.
- Ensures functional strategy and plans are developed, maintained, and executed this can include training, communication, device management, data management, document management and quality documents.
- Conducts appropriate training of country staff and sites on protocol and project specific matters.
- Responsible for vendor management activities including selection and contract development.
- Serving as a key Client's clinical operations contact for internal and external (clinical sites, vendors, etc.) teams for assigned studies.
- Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and Client's SOPs for assigned studies.
- Track and manage site engagement in recruitment activities to identify proactive solutions and maintain consistent screening activity.
- Ensure appropriate stakeholder communication, including study status, expectations, risks and issues.
- Lead quality efforts to ensure study compliance and continual inspection readiness for assigned studies.
Basic Requirements:
- Strong background in study execution
- Experience in working with global/regional teams or changes impacting multiple geographies
- Track record of delivering on time clinical research milestones
- Desire to be part of a multifunctional team to problem-solve and work toward shared goals
- Strong communications and influencing skills
- Bachelors level degree or equivalent
- Strong interest in working in an entrepreneurial environment
Source : LanceSoft Inc
