Position Summary: 

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 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 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 and guidance documents to increase knowledge share of country specific site start-up activities. 

Essential functions of the job include but are not limited to:  

Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery. Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution. 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. Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up. 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.   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 levels. Responsible to co-ordinate translations for documents required for submissions. 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 status and deliverables. 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 and budget negotiation requirements that may be in place as well as other start up requirements for assigned country. If needed, directly support country or site level activities start up activities. Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors. Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries. Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL. Interact with clients in proposal activities, including slide development and client presentation as required. Performs other duties as assigned by management. 

 

Qualifications: 

Minimum Required: 

Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience. 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities. 

Other Required: 

Demonstrated leadership experience in driving cross-functional activities Excellent communication and organizational skills are essential.   Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. Fluency in English and for non-English speaking countries the local language of country where position based. Experience using milestone tracking tools/systems 

Preferred: 

Advanced degree in life sciences or related field 

Competencies:  

Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information. Excellent organizational skills. Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located. Ability to work independently in a fast-paced environment with a sense of urgency to match the pace. Must demonstrate excellent computer skills. Excellent time management and prioritization skills to ensure deadlines are met. Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade. Occasional travel may be required.