Clinical Trial Manager

ABOUT USSimbec-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 ROLEWe are looking for a Clinical Trial Manager to join our Clinical Operations team where you will be r esponsible for managing the planning, implementation, and tracking of all clinical operations functions within a study.

You will manage ongoing Clinical Operations tasks and oversee CRA and IHCRA activities. You will liaise closely with Project Management, Project Leads and the Sponsor.

You 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.

KEY ACCOUNTABILITIES* Responsible for management and oversight of CRA and IHCRA activity on the assigned study.

• Responsible of preparation, maintenance and execution of Clinical Operations plans.
• Ensures study team receives study specific training according to Simbec Orion SOPs.
• Ensures all clinical operation tasks are delivered on time and within agreed budget.
• Communicates progress of clinical operation functions and assists project manager with tracking of project status.
• Assists project manager with budgeting throughout the project and forecasting of clinical operations tasks within URF.
• Contributes to regular updates to Clinical Trial Management Systems.
• Attends and conducts project and internal calls as per budget to gather and deliver required clinical operation updates
• Management of the identification, selection and activation process of study sites
• Collaborates with cross-functional study team and study vendors as needed
• Provide feedback to management on any current or potential risks or problems affecting the outcome of the clinical trial.
• Escalate in timely manner any issue related to Quality, Patient Safety or Data integrity.
• Produce accurate and timely visit reports in accordance with the monitoring plan and / or SOPs.
• Conduct accompanied site visits with CRAs as required
• Cover for CRAs that work 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 or Associate Project Manager
• Competent in clinical trial planning and metrics management
• Excellent communication skills
• Strong presentation 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
• Good working knowledge of applications and Systems (e.g., CTMS, eTMF, IVRS / IWRS and EDC) *DESIRABLE*
• Previous CRO experience
• Multiple therapeutic experience, preferably oncology, and proven ability to gain in-depth protocol knowledge
• Experience in study Start-up, budgeting, and forecasting WHY YOU SHOULD JOIN USSimbec-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.