PRIMARY FUNCTION: The Senior Project Manager is responsible for delivering the operational aspects of one or more clinical study. May manage more complex, global studies.
MAJOR RESPONSIBILITIES: - Lead a group of project managers, responsible for delivery the operational aspects of one or more clinical studies which may be more complex or multi-country studies. * Manage interdisciplinary clinical research projects. * Lead the clinical team to ensure quality, timelines and budget management. * Act as a resource for other team members. * Accountable for all project deliverables for each project assigned. * Coordinate activities and deliverables of all study conduct partners and proactively identify and managing issues. * Ensure studies are conducted in compliance with GCP, relevant SOPnd regulatory requirements. * Responsible for study management components of inspection readiness for all aspects of the study conduct. * Oversight for development and implementation of project plans. * Plan, coordinate and present at internal and external meetings. * Prepare project management reports for clients and InVentiv Health management. * Implement resource strategies to achieve teamroject goals, including contingency planning and risk mitigation strategies to ensure successful delivery of study goals. * Manage study management components of protocol level budget.
SUPERVISORY / MANAGEMENT RESPONSIBILITIES:
- Supervise, coach, and mentor staff * Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching * Set priorities and schedule activities of departmental resources, implement company objectives, and create alternative solutions to address business and operational challenges
Qualifications EDUCATION REQUIRED: - Bacheloregree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred.
MINIMUM TRAINING & EXPERIENCE REQUIRED:
- 5 years of relevant clinical research / study management experience with an understanding of clinical drug development, study execution and clinical trials operations. * International clinical trial experience desirable * Extensive knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements * Strong organizational skills * Strong ability to manage time and work independently. * Direct therapeutic area expertise * Proficiency with word processing software (MS word), spreadsheet software (MS excel) and presentation graphics software (MS PowerPoint) * Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade * Ability to travel as necessary (approximately 25% travel)
