Clinical Trial Lead

Remote, Italy; Homeworking
Competitive
12 Sep 2022
12 Oct 2022
1094980281
Full Time
Permanent
Experienced (non-manager)
ABOUT US

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 the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

THE ROLE

We are looking for a Clinical Trial Lead to join our Clinical Operations team where you will be responsible for managing the planning, implementation, and tracking of the clinical monitoring process. You will maintain an overview of ongoing tasks within the Clinical Operations department and acts as a guide to Clinical Research Associates and In-House Clinical Research Associate activities.

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

KEY ACCOUNTABILITIES

  • Responsible for oversight of CRA and IHCRA activity on the assigned study.
  • Responsible for the Preparation, maintenance and execution of Clinical Operations plans.
  • Ensures study team receives study specific training according to Simbec-Orion SOPs.
  • Ensures all monitoring tasks are delivered on time and within agreed monitoring budget.
  • Communicates progress and assist Project Manager with tracking of project status.
  • Assist Project Manager with budgeting throughout the project and forecasting of URFs.
  • Contributes to regular updates to Clinical Trial Systems.
  • Act as a CRA on the project, where necessary.


SKILLS REQUIRED

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


WHY YOU SHOULD JOIN US

Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.

We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.

With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you. our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.