Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.
With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of your project, helping you achieve your clinical and commercial objectives. Because our goal is the same as yours; to improve patients' lives. Main Duties and Responsibilities:
We are looking for a Clinical Trial Lead to join our Clinical Operations department. You will be based remotely in the US and will be located in the Mid-West, Central or East Central.
As a Clinical Trial Lead you will work closely with Project Management to lead the clinical part of the study, contributing to the scope of work with Project Management, Business Development and the Sponsor. You will ensure deadlines for the clinical component of projects are met in accordance with the contracted scope of work, budgeted hours and timelines.
As the CTL you will lead the Clinical Research Associate team to ensure compliance with monitoring plan, study protocol and ICH-GCP and will mentor the Clinical Research Associates and provide feedback on performance to the Project Manager and the CRA Manager.
You may also conduct Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits and Close Out Visits when required. Minimum Requirements: Essential:
- B achelor's degree in Life Sciences or related fields
- Previous experience in clinical research as a Senior CRA or equivalent relevant experience
- In depth knowledge of European clinical research regulations, GCP, and ICH
- Strong presentation and problem solving skills.
- Ability to establish and maintain effective working relationships with colleague and clients
- Previous experience of working with CTMS and eTMF systems.
- Strong working knowledge of project finance, study budgets and project management.
- Previous experience of managing resource allocation, processes, quality, and project delivery
- Competent in clinical trial planning and metrics management
- Ability to make decisions independently
- Strong scientific knowledge
- Strong leadership, mentoring, and motivational skills
Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
- Advanced degree (Masters, MD, PhD)
- Line management experience in CRO setting
- Advance level knowledge in Excel and PowerPoint
- Diverse therapeutic expertise including Oncology and or rare diseases
- Previous experience as a Clinical Trial Lead/Lead CRA