Clinical Study Manager

Philadelphia, PA
August 09 2021
Organization Type
Job Type
Site Name: USA - Pennsylvania - Philadelphia Posted Date: Aug 9 2021 Are you energized by the opportunity to partner with key leaders in Global Monitoring and Site Engagement? If so, this Local Delivery Lead could be an exciting opportunity to explore. The Clinical Study Manager is pivotal to trial delivery and compound development for the Global Monitoring and Site Engagement organization, providing leadership and driving decisions related to the conduct of a clinical trial in the U.S. The LDL leads and manages the operational implementation of within-country feasibility, planning and delivery of US R&D Pharma Phase I-IV clinical studies within and across therapeutic areas. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Accountable for operationalizing assigned studies within country and overall project management of study activities resource estimates, milestones, timelines, quality, and risk planning Ensures development and maintenance of country study plan and forecast, including detailed budgets Manages in-country study communications & issue escalation; communicates progress & escalates issues to the Study Delivery Lead (SDL) and other functions (i.e., Local Delivery Lead Director) Develops/manages the development of local aspects of key study documents, plans & manuals (e.g., monitoring plan, study reference manual, etc.); develops local recruitment and other site support materials Coordinates as necessary key local requirements including local informed consent form, institutional review committee approvals, clinical study agreement (CSA), third party agreements & payments Selects & manages local vendors in accordance with local practices and in alignment with overall resourcing strategy for the study; accountable for vendor management including oversight, payments, communications & issue management Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: B.S. / B.A. degree or equivalent; major course of study in health-related sciences preferred 5 or more years in clinical development or equivalent experience in the pharmaceutical or health-related field (Study Management, Field Monitoring or similar experience) Experience in project management and matrix team interactions. Preferred Qualifications: If you have the following characteristics, it would be a plus: High level of understanding of clinical research management, field monitoring or similar experience gained through clinical trial management, and the associated regulatory, process and quality requirements; strong knowledge/experience in project management and matrix team interactions Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements Demonstrates the discipline of risk-based planning, organizing and managing resources to ensure successful completion of specific project goals and objectives Exhibits strong project management skills (including scope, budget, timeline, and resource planning) and budget information (i.e., demonstrates business and financial acumen) management, and use of associated tools and support where available Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others Able to set and manage priorities, resources, performance targets in a local environment Effectively plans, communicates, coordinates and facilitates delivery of team objectives Operational expertise in risk management and contingency planning Solid understanding of local and FDA regulations, GCP/ICH-guidelines Available and willing to travel for project related activities as required (e.g., Investigator Meetings, team meetings, etc.) Acts as role model in line with company core values and behaviors; willingness to mentor/train staff Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. 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