Senior Clinical Trial Manager

Simbec-Orion

About The Position

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.

Requirements

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).

Nice To Haves

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

Responsibilities

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.