The Senior Study Manager will be accountable for the overall management of assigned clinical studies and act as a mentor for study managers.
Manage multiple projects and lead multiple study teams simultaneously.
Design risk- based strategy for studies assigned.
Monitor studies against defined risk triggers, milestones and timelines to assure that all deliverables are met. Facilitate the development and implementation of remedial activites when necessary. Lead an expanded study team meeting to review study status using powerpoint presentations and WebEx technology. Attend weekly teleconference with CRO (if applicable).
Identify and select high-quality clinical vendors in conjunction with the appropriate team members by interviewing and assessing a vendor’s skill set. Work with the contracting/budgeting team to ensure that vendor responsibilities and payment terms are clearly defined.
Manage and effect oversight of assigned clinical vendors and functional service providers to ensure data integrity and adherence with regulatory requirements. Assure that team is receiving high quality, on time deliverables from internal and external vendors.
Collaborate with other team members to coordinate the development and finalization of key study documents including protocols, case report forms, informed consent documents, study management plans and final clinical study reports.
Communicate with Principle Investigator, Study Co-Ordinator, and/ CRO (if applicable) to proactively recognize problem situations and work with other team members as required to resolve issues.
Independently identifies and drives the operational aspects of all assigned clinical trials. Consults other functions (medical, data management, statistics, etc.) as needed.
At least 10 years of experience in the management of global clinical trials, significant knowledge of overall clinical drug development and general clinical research operations.
Ability to manage multiple projects simultaneously with strong organizational and planning skills.
Well-developed analytical and problem solving skills.
Knowledgeable in all required regulatory and compliance standards and guidelines including ICH-GCP.
Ability to effectively work with teams and promote collaborations. Exceptional interpersonal skills including the ability to influence negotiate and resolve conflicts.
Excellent verbal and written communication skills and the ability to interact with all levels of management within the organization and to external business contacts.
Experience using the Inform database, PowerPoint and Excel software.
Independent judgment and decision making skills with respect to functional responsibilities.
Innovative and motivated in optimizing clinical operations processes to meet deliverables.
Knowledge of risk-based monitoring concepts.
Minimum BS or BA in related field; focusing on biological science preferred or equivalent. Advanced Degree preferred