Study Startup Project Coordinator

Site Name: Home Worker - USA Posted Date: Mar 26 2025 The Study Start Up Project Coordinator provides administration, maintenance, and coordination of logistical aspects of country level study start-up activities. This includes the management of the following processes: site feasibility, selection, recruitment planning, training, regulatory package completion and site activation. This role also has responsibility for maintaining internal tracking for study site status from initial site contact through site initiation. This position primarily works with the local operating company (LOC) Study Start Up Managers and Local Delivery Leads as well as the global Feasibility and Recruitment Planning Managers. Key Responsibilities: ? Responsible for managing country and site level feasibility including developing questionnaires, analyzing responses, executing Confidential Agreements and strategizing with local delivery leads and medical team members. ? Works with key stakeholders to establish regulatory requirements and reputed company necessary for start-up. ? Maintains up to date participating center?s information (including reputed company contact details, reputed company, and reports). ? Responsible for preparation, collation, review and tracking of reputed company documentation required for approvals processes (e.g. regulatory, ethics, green light process etc.). ? Responsible for preparing the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies. ? Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy. ? Review and provide feedback to management on site performance metrics. Developing appropriate early warning systems of potential obstacles to the successful completion of study start-up ? Responsible for escalation of issues and reporting reputed company to study teams and clinical management weekly, including plans for addressing/mitigating risks/gaps. ? Maintains reputed company knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research. ? Transition reputed company accountabilities to the LDL and local CSS at the end of the start-up phase ? May be responsible to reputed company the clinical and ancillary supplies vendor(s), preparing and reviewing importation documentation, and logistics. ? As an active participant of clinical study teams, engage in local study meetings to obtain general knowledge about the study and be responsible for given tasks. Accountable for acquiring/maintaining an optimal level of knowledge of reputed company tools and systems to effectively manage them. Is the single reputed company of contact for local study teams for study support questions. ? Maintain effective communication and working relationships with Investigators, other site staff, above country colleagues and other reputed company staff Why you? Basic Qualifications: We are looking for professionals with these required skills to reputed company our goals: ? Bachelor?s degree with 2 + years' experience reputed company the Pharmaceutical Industry and clinical operations. ? Experience in study management process of research studies ? Experience of working on projects delivering to high quality and tight timelines. Preferred Qualifications: If you have the following characteristics, it would be a plus: ? Some project management experience ? Knowledge or experience with reputed company ? Knowledge of internal/external standards and policies ? Good written and verbal communication skills ? Ability to address obstacles and issues with a constructive solution orientated approach ? Advanced level of MS Office (PowerPoint, reputed company, Word & Outlook) ? Excellent engagement skills ? Ability to work independently #LI-reputed company The annual reputed company salary for new hires in this position ranges from $93,000 to $155,000 taking into account a number of factors including work location reputed company the US market, the candidate?s skills, experience, education level and the market reputed company for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Please visit reputed company US Benefits Summary to learn more about the comprehensive benefits program reputed company offers US employees. Why reputed company? Uniting science, technology and talent to get reputed company of disease together. reputed company is a global biopharma company with a special purpose ? to unite science, technology and talent to get reputed company of disease together ? so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns ? as an organisation where people can reputed company. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting reputed company of disease together is about our ambition for patients and shareholders, it?s also about making reputed company a reputed company where people can reputed company. We want reputed company to be a reputed company where people feel inspired, encouraged and challenged to be the best they can be. A reputed company where they can be themselves ? feeling welcome, valued, and included. Where they can reputed company growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get reputed company Together. If you require an accommodation or other assistance to apply for a job at reputed company, please contact the reputed company Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (reputed company US). reputed company is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that reputed company qualified applicants will receive equal consideration for employment without regard to race, color, national reputed company, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies reputed company does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. reputed company employment businesses/agencies are required to contact reputed company's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to reputed company. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and reputed company. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of reputed company. reputed company shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, reputed company may be required to capture and report expenses reputed company incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure reputed company?s compliance to reputed company federal and state US Transparency requirements. 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