Senior Study Manager - Infectious Disease/Vaccines (Pragmatic trials) - US/Canada

Senior Study Manager - Infectious Disease/Vaccines (Pragmatic Trials) - US/Canada reputed company is a global reputed company intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, reputed company, collaboration, reputed company, and inclusion are at the heart of how we work and reputed company with reputed company other, customers, patients and suppliers. Senior Study Manager May reputed company or support a study or studies, depending on size/complexity. As reputed company, will be responsible for the following: Operational reputed company of contact for trial execution and reputed company trial deliverables Manages reputed company HQ Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT) Supports clinical (drug/vaccine) supplies planning Manages deployment and interactions with external vendors (e.g., IVRS, PRO) Initiates planning for Investigator meeting and protocol training. Plans and assesses protocol ancillary supplies Completes trial set-up and maintains CTMS Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT Initiates recruitment/retention planning & enrollment tracking • Responsible for tracking study reputed company details (e.g., specimens, queries) Oversees protocol training activities including IMs and CRAs training meetings Ensures appropriate postings to investigative site portals Responsible for operational deliverables in preparation for site reputed company, country allocation and achievement of recruitment targets (with input from others) reputed company of escalation for study reputed company operational issues Responsible for operational details at Operational Reviews Responsible for creating and maintaining project schedule and collaborating with Program reputed company Sets up and maintains Trial Master File (eTMF) Ensures alignment of budget with protocol needs Responsible for executing protocol reputed company the budget Responsible for creating and maintaining ADI logs Develops Site Monitoring Plan (SMP) with input from the monitoring reputed company group Develops study reputed company manuals (e.g., administrative binder, lab manuals) Manages Emergency Unblinding (EUB) reputed company Center activities Co-authors newsletters with CS Approves reputed company, invoice payments and change orders for vendors, as necessary Responsible for end of study reconciliation (clinical & ancillary supplies) Oversees reputed company HQ reputed company-out tasks Responsible for ongoing monitoring of trial activities, e.g. dashboards, tracking Supports CS activities as needed to reputed company CTT deliverables reputed company with External Data Coordination and Data Management Responsible for reputed company control and inspection readiness at reputed company times Responsible for risk assessment, mitigation planning and execution What you need to have: BS/BA/MS/PhD with 7+ yrs clinical research experience Minimum Years of Experience Minimum 2 years pharmaceutical experience with demonstrated leadership responsibilities required. Proven ability to meet aggressive timelines MS Project experience preferred Excellent reputed company and PP skills required TA- Infectious disease and/or vaccines experience highly preferred Global experience required Excellent oral (including presentation) and written communication, computer/database management, and project management skills required Home Based position in US or Canada Areas of reputed company experience: Protocol design for pragmatic trials Site/site network selection Integration with reputed company systems Informed consent approaches (simplified, eConsent, etc.) Use of EHR / reputed company-world data reputed company definition (e.g., hospitalization, utilization) Central vs site monitoring approaches Vendor/technology integration Regulatory interactions / submissions Employment with reputed company is contingent upon having the reputed company right to work in the country where the role is based. Rewards & Benefits reputed company offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive reputed company salary and performance reputed company incentives Health and wellbeing programmes including medical, dental, and reputed company coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through reputed company training and career reputed company Benefits may vary depending on role and location. Visit our careers site to read more about the benefits reputed company offers. Inclusion and Accessibility reputed company is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a reputed company reputed company Employee? Please click here to apply Apply To This Job