Project Manager, RWE Clinical Trials (Remote)
About the position Responsibilities • Lead and coordinates project activities and leads completion of deliverables in alignment with overall program strategy considering impact to risks/risk mitigation, budget, effort estimates and schedule • Serve as the point of contact for the Sponsor and other functional team members for the assigned clinical trial project • Participate in bid defense preparations. Lead bid defense presentations in partnership with the Business development team • Lead activities across numerous functions to meet the objectives of a given program including scope, budget, and schedule • Establish and maintain project documentation and procedures • Develop risk mitigation plans including appropriate communication and escalation plans to mitigate risk • Collaborates closely with other core team leaders within the Clinical Trials business • Demonstrates the ability to proactively identify solutions to improve existing business processes • Understands and maintains compliance with internal and external privacy and legal • Manage the project finances in accordance with the customer contract and the budget; Work closely with the Director of Finance, RWE Clinical Trials • Identify changes in scope and manage the change control process, as necessary Requirements • Bachelor's Degree and at least 2 years of experience in clinical research and project management experience OR High School GED and at least 5 years of experience in clinical research and project management experience • Bachelor's degree in Life Sciences or related field and at least 2 years of clinical research and project management experience • Experience collaborating with others to deliver results to meet timeline, metrics and budget • Knowledge of the use of RWE for clinical trials • Knowledge of EDC systems and technology enabled solutions (EMR/Health Record Experience, Hybrid trials) with respect to use in clinical trials • Knowledge of clinical trials, and experience applying applicable clinical research regulatory requirements (i.e. GCP and ICH guidelines) • Experience utilizing a results oriented to delivery • Knowledge of project finances including experience managing, contractual obligations and implications • Experience organizing resources needed to complete tasks, set objectives, and provide clear direction to other team members • At least 1 year of direct leadership, indirect leadership and/or cross functional team leadership • Willing to travel up to/at least 15% of the time for business purposes (within state and out of state) Apply tot his job