Manager, Clinical Operations - CRM/CTCs - Home Based
PRA Health Sciences
Req #: 113718
Type: US
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Overview: As a Manager Clinical Operations you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities: Responsibilities * Recruit, interview and identify experienced personnel according to Functional Resourcing Process timelines. * Ensure and oversee proper on‐boarding and off‐boarding of employees, compliance to initial and ongoing trainings. * Will oversee CRM and CTCs * Train and oversee the CORE competencies, ICH‐GCP knowledge, clinical research environment, monitoring etc. * Assure adherence to GCP guidelines, processes and procedures related to direct reports' activities and performance. * Assure adequate response /escalation and follow‐up on items assigned to direct reports by Sponsor. * Ensure direct reports are providing timely and quality deliverables. * Plan" and inform Sponsor of any quality concerns in a timely manner. * Conduct regular 1:1 meetings according to Partner's "PLM Oversight Plan" with direct reports to ensure deliverables and timelines. * Ensure direct reports are compliant to the timelines and key business metrics defined by Sponsor. * Ensure at least monthly meetings with Sponsor country management to confirm performance of direct reports regarding protocols / sites assigned. * Communicate and escalate areas of development and training needs. * Conduct continuous Performance review and oversee Personal development and career planning of direct reports. * Provide timely feedback to Sponsor on performance and ensures proper follow‐up. * Review and approve timesheets, GTT compliance, expense reports, time‐off requests and provide proper oversight of CRM and/or CTC productivity/utilization. * To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status Qualifications: What you need * Bachelor's degree * Minimum 6 years Clinical Research experience that includes a minimum at least 2 years as a line manager of Project Managers, CRAs or In house CRAs. * Excellent management skills, developed with a collaborative approach to driving performance and success in a global environment * Direct experience managing Clinical Trial Managers and In House CRAs is preferred * Substantial experience using computerized information systems including experience with PC- Windows, word processing, and electronic spreadsheets required * Substantial clinical trials development experience is required * Experience supervising or managing professional staff in a clinical research environment required * Thorough knowledge of ICH and local regulatory authority regulations regarding drug research and development is required * Excellent written and oral communication. * Has a good knowledge of Clinical Operations processes and systems. * Understands interrelation of Clinical Operations functions within the department and across the full clinical trial process * Ability to set expectations and monitor employee performance. * Strong mentoring and leadership skills * Ability to identify and hire strong candidates through hiring processes * To qualify, applicants must be legally authorized to work in the US, and should not require, now or in the future, sponsorship for employment visa status What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs * Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead * Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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