PrahaJob IntroductionAre you interested in the dynamic Clinical Research Industry?Do you want to work for a leading multinational organisation, renowned throughout the industry for its meteoric rise to success and dependability to deliver on global contracts across multiple therapeutic areas and phases?
Our business in the Czech Republic is growing and we are currently looking to recruit a Clinical Trial Manager (CTM).This brand new role will be responsible for effective management of key studies to ensure delivery within agreed budget, schedule and quality requirements.
Main ResponsibilitiesKey roles and responsibilities of the Clinical Trial Manager are as follows Collaborate with a Project Manager to ensure recording of trial in compliance with project goalsAct as the lead study reference for assigned studies and provide local oversight and leadership through the entire study life cycle from initiation to close-
outFacilitate site qualification visitsAct as the point of contact for all external and internal agencies, ClientsThe overall efficient day-
to-day management of the trial.Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
Analyse recruitment methods against results and help implement changes to strategy during the study and at close, with feedback to appropriate departments to ensure future learnings.
Monitor assigned study activities to ensure Site Initiation Visits are booked and completed, continue the pre-identification of patients in order to build the study funnel, with a goal for Synexus sites to be the first to randomise patients into the study and ensure patient retention where applicable etc.
Assuring compliance SOPs and local regulations, and CFR, ICH and GCP guidelines.The Ideal CandidateTo be considered for this brand new, exciting opportunity you will require the following skills and experience : Bachelor’s degree in a life science or related field of study OR equivalent combination of studies, science qualifications and / or work experienceKnowledge of clinical research environment, governance and legislative framework for conducting clinical studies, including Good Clinical Practice (GCP)Have previous experience in managing all clinical trial components (start-
up to database lock),along with accountability for the study budgetexperience in Clinical Trial Study Management or Clinical Trial Project Management or a combination of qualification and experiencePlan and deliver studies using good study management practice and tools, along with a clear understanding of study managements standardsProficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies managementPrior experience of delighting customers through effective delivery of robust customer service levelsAbility to work independently and prioritize duties.
Demonstrated ability to lead, mentor and provide clinical guidance to team membersWell developed organizational skills in a complex and fast-
paced environmentComputer literate and have good skills in Project Management tool, Excel, Word and Power PointExcellent verbal and written communication skills in English (advanced level)Interested?
Great, please apply ASAP.Synexus is an Affirmative Action and Equal Opportunity Employer.About The Company Our Dedicated Research Sites are where high quality staff engagement and top of the class facilities meet with the client expectation for fast enrolment and delivery.
Dr Radoslaw Janiak (President & COO)Our success is based on a simple, but crucial, principle. We place the patient at the heart of everything we do.
Synexus is a world class Site Network Organisation with global expertise spanning patient recruitment, trial planning, management and patient retention.
We recruit and retain more engaged patients, at fewer sites, and in less time than traditional centres, enhancing the quality and efficiency of our customers’ drug development programmes.
Package DescriptionCompetitive + Bonus + Benefits