Clinical Manager II / Senior Clinical Manager (Romania) Nr ref.: /JOBS.pl Role: Clinical Manager II or Senior Clinical Manager Location: Bucharest, Romania OR Home Based Contract: Permanent Are you looking for a change? Looking to make a difference, check us out! Premier Research helps highly innovative biopharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research Our Clinical Managers direct, supervise and support all clinical staff on the project team; liaises with the customer's clinical team and collaborates with project team members in other functional areas to ensure delivery within contractual obligations and Premier's standards of excellence. We are seeking a talented Clinical Manager II / Sr. Clinical Manager to join our team. You will be accountable for: Ensures the effective selection, initiation and motivation of clinical study plans Plans and drives patient recruitment and retention Ensures that the clinical team adhere to the appropriate training needs and performance indicators Takes the initiative to move the project/program forward and leads in country and global projects where applicable Is customer focused on both internal and external customers Leads and manages the clinical start-up and monitoring teams with focus on deliverables Supports Project Management in the development and review of the protocol/study design, case report forms, informed consent forms and other documents Works with the Project Manager to ensure transparent and proactive sponsor and internal communication regarding study progress and trial issues Plans and conducts initial and ongoing training for the study team on project-specific matters and enlists therapeutic assistance where applicable Develops a clinical monitoring plan as well as clinical monitoring tools Prepares and executes a site and patient recruitment and retention plan Serves as initial point of contact for all clinical management and monitoring issues, vendors and other functional areas, escalating as required Monitors the preparation and timely completion of all monitoring visit reports, reviews them for appropriate content, and ensures effective follow up and resolution of site issues Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member Works with the Data Management team to identify data related issues and risks to clinical activities; assists in the development of mitigation plans to minimize risk May serve in a dual CM/PM role on smaller studies You'll need this to be considered: Undergraduate degree in a clinical, biological, scientific, or health-related field from an accredited institution; a licensed health care professional (i.e. registered nurse); or equivalent work experience required Read, write and speak fluent English; and fluent in host country language Strong experience in clinical trial management as a CM Experience in managing complex or global trials Budget/finance experience on a project level and demonstrates a full understanding of project financials If you are looking for a career within a transparent and non-hierarchical organisation then please contact us at the email address listed below. We are open minded and flexible regarding the talent we recruit, ultimately we are looking for people who will share in our vision and realise the importance of communication, building relationships and adhering to the highest quality standards. Please note:- You must be eligible to live and work in Romania in order to apply for this role. Keywords:- Clinical Manager, Clinical Trial Manager, Senior Clinical Trial Manager, Clinical Team Lead, Clinical Team Leader, Study Manager, Lead CRA, Permanent, Office Based, Bucharest, Romania, Pharmaceuticals, CRO, Clinical Research, Contract Research Organization, Permanent, Full Time, Clinical Trials, Pharma Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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