Start up Lead/Senior Start up Lead

<p>Precision for Medicine (CRO) are hiring an experienced Start up Lead/Senior Start up Lead who have a passion for site start up to join our team, candidates can be based in the following countries:  UK, Spain, France, Italy,  Hungary, Slovakia, Serbia, Romania or Poland.  The level of position offered will depend on level of experience.</p> <p><strong>Position Summary:</strong><br/>The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as<br/>Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions <br/>by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools <br/>and guidance documents to increase knowledge share of country specific site start-up activities.</p> <p><strong>Essential functions of the job include but are not limited to: </strong><br/>• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.<br/>• Coordinate, develop and present critical path planning including IRB/EC &amp; CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.<br/>• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.<br/>• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.<br/>• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.<br/>• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site <br/>levels.<br/>• Responsible to co-ordinate translations for documents required for submissions.<br/>• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific <br/>status and deliverables.<br/>• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts <br/>and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.<br/>• If needed, directly support country or site level activities start up activities.<br/>• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.<br/>• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.<br/>• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.<br/>• Interact with clients in proposal activities, including slide development and client presentation as required.<br/>• Performs other duties as assigned by management.<br/><br/><strong>Qualifications:</strong><br/><strong>Minimum Required:</strong><br/>• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination <br/>of education, training, and experience.<br/>• 5 years or more in start up, with SU Lead or PM experience in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies.<br/>• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.</p> <p>Other Required:<br/>• Demonstrated leadership experience in driving cross-functional activities<br/>• Excellent communication and organizational skills are essential. <br/>• Experience using computerized information systems, electronic spreadsheets, word processing and <br/>electronic mail required.<br/>• Fluency in English and for non-English speaking countries the local language of country where position <br/>based.<br/>• Experience using milestone tracking tools/systems</p> <p><br/><strong>Preferred:</strong><br/>• Advanced degree in life sciences or related field<br/>Competencies:<br/>• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.<br/>• Ability to follow task-specific procedures, be attentive to detail and place importa