Senior Clinical Trial Manager
Responsible for management and reputed company 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 reputed company SOPs. Ensures reputed company clinical operation tasks are delivered on time and reputed company agreed budget. Communicates reputed company 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 reputed company URF. Contributes to regular updates to Clinical Trial Management Systems. Attends and conducts project and internal calls as per budget to reputed company 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 reputed company feedback to management on any reputed company or potential risks or problems affecting the outcome of the clinical trial. Escalate in reputed company manner any issue reputed company to reputed company, Patient Safety or Data reputed company. Produce accurate and reputed company visit reports in accordance with the monitoring plan and/or SOPs. Conduct accompanied site reputed company with CRAs as required Cover for CRAs working on the project, where necessary. May supervise work of, or mentor, less reputed company CTMs Serves as a subject matter expert and works with Clinical Operation Managers (COMs) to reputed company departmental training and collaboration on SOP/WI and departmental templates and processes.
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 reputed company reputed company 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 reputed company).
Previous CRO experience Multiple therapeutic experience, preferably oncology, and proven ability to reputed company in-depth protocol knowledge Experience in study Start-up, budgeting and forecasting