Associate Country Project Manager

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Trialmed Associate Country Project Manager - Make an Impact at the Forefront of Innovation Purpose :     Manages assigned studies to ensure delivery within agreed schedule and quality requirements. To effectively execute the prime contract at a local level by implementing the global study strategy and proactively managing risks for the best possible outcome for the business. Positively represent the company to external stakeholders, providing excellent customer service and expedited excellence. Interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works closely with global functional departments and sites to ensure that all deliverables meet or exceed the customer's time, quality and cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope. Motivate and inspire local teams to keep the studies on track to a successful outcome and capitalize on opportunities arising throughout the lifecycle of the study. Typically works on standard projects of low to moderate complexity. May be frequently assigned as local support on global and/or multi-country studies supporting the global study lead to ensure smooth communication as well as successful and timely delivery at local level.     Es s e n t ial F u n c t i o ns a n d O t h e r J o b Info r ma t i o n :     Major Job Responsibilities   Acts as the lead study reference, for assigned projects which are typically of low to moderate complexity, providing global, territorial and site-level oversight and leadership and managing local clinical operational and quality aspects in compliance with company quality framework, ICH GCP and international standards throughout the entire life cycle from initiation to close-out.   Acts as a supporting colleague on more complex studies working closely with more senior CPMs.   For certain projects, coordinates start-up activities or works in collaboration with the global start-up team. Facilitates successful site qualification visits and site initiation visits as well as timely ethics committee and regulatory submissions (if appropriate). Reviews and follows up on all questions raised by the ethics committees. Ensures potential rate limiting factors (e.g. drug supply, vendors) are identified and managed to ensure maximum and seamless recruitment.   Continuously measures and assesses study performance by collecting and analyzing study metrics to determine where the study stands and to predict future status and progress with the overall goal to ensure that contractual obligations are met (or organizing contract amendments as necessary). Regularly reviews projects using tracking and management tools, provides status updates to the O&SS Lead, identifies risks and implements proactive solutions and recovery actions, identifies problems and escalates appropriately and in a timely manner.   Monitors and analyzes recruitment methods against results in collaboration with GEO and pre-identification, processing and retention of patients at sites against target to ensure a strong study funnel and to help implement changes to the strategy during the study and at close, with feedback to appropriate departments to ensure future learnings.   Ensures timely set up, organization, content, quality and archving of the relevant sections of the local Trial Master File if applicable. Maintains files, incl. contract logs, amendment logs and other documents.   Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained.   Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.