Project Manager - Sponsor Dedicated (Inflammation)

Syneos Health is a biopharmaceutical solutions organization that supports clinical development and sponsor collaboration. The Senior Project Manager will provide oversight and guidance for international inflammation clinical trials, managing operations, timelines, budgets, vendors, study teams, and trial-related documentation.

Responsibilities:

• In partnership with Clinical Program Manager or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
• Communicates with functional peers regarding project status and issues and ensure project team goals are met
• Oversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out
• Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report
• Coordinates data review to support interim/final data analysis
• Participates in study strategy development
• Maintains study timelines
• Contributes to development of study budget
• Contributes to development of RFPs and participate in selection of CROs/vendors
• Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, recruitment vendors, investigators and study coordinators on study requirements
• Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management)
• Proactively identifies potential study issues/risks and recommends/implements solutions
• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
• Participates in the recruiting and hiring process for CPA/CTMAs and supports their professional development
• Coaches members of a work team and ensures adherence to established guidelines

Requirements:

• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
• Extensive Study Start-up Experience
• Global clinical trial experience
• Prior involvement in Inflammation studies
• Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
• Highly developed leadership skills to successfully lead a clinical study team
• Ability to deal with time demands, incomplete information or unexpected events
• Must display strong analytical and problem solving skills
• Attention to detail
• Outstanding organizational skills with the ability to multi-task and prioritize
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities