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.

You will be r esponsible for managing the planning, implementation, and tracking of the clinical monitoring process and will maintain an overview of ongoing tasks within the Clinical Operations department and acts as a guide to CRAs and IHCRA activities.

You will also liaise closely with Project Management, Business Development and the Sponsor and will have a significant role in ensuring deadlines of projects are met in accordance with contracted scope of work, budgeted hours whilst ensuring maximum efficiency and quality.

Minimum Requirements:

Essential:

• Bachelor's degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience required
• Experience as a Clinical Research Associate III
• Excellent communication skills
• Proficiency in written and spoken English; fluent in host country language
• Expert knowledge of relevant clinical research regulations and ICH-GCP
• Ability to establish/maintain good relationships with sites/colleagues/clients
• Ability to make decisions independently / Strong problem-solving skills
• Highly developed mentoring and motivational skills

Desirable:

• Previous CRO experience
• Good experience in CTMS, eTMF IXRS and EDC systems
• Advanced degree (Masters, MD, PhD)
• Strong presentation skills
• Competent in clinical trial planning and metrics management
• Multiple therapeutic experience and proven ability to gain in-depth protocol knowledge

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.