Our Mission:
Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine.
We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.
The Role:
We are seeking an experienced clinical operations professional to take ownership of the planning, delivery, and oversight of clinical studies. In this role, you will lead the coordination of all Clinical Operations activities, ensuring studies are executed efficiently, to a high standard, and in line with agreed timelines, scope, and budget.
You will oversee CRA and IHCRA activities, working closely with Project Management, Project Leads, and Sponsors to ensure seamless study delivery. As a subject matter expert, you will also play a key role in mentoring and developing colleagues, contributing to the continuous improvement of Clinical Operations across the organisation.
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 working on the project, where necessary.
- May supervise work of, or mentor, less experienced CTMs
- Serves as a subject matter expert and works with Clinical Operation Managers (COMs) to provide departmental training and collaboration on SOP/WI and departmental templates and processes.
Skills Required:
ESSENTIAL
- Bachelor’s degree in Nursing, Life Sciences or Medical Sciences
- or equivalent work experience required
- Experience as a PM, CTM or equivalent role
- Competent in clinical trial planning and metrics management
- Excellent communication & 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
About Us:
Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to 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 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.