Senior Clinical Study Manager

Primary Function of the Position

This position requires a candidate with extensive experience supporting evidence generation strategy and execution of clinical studies. The Senior (Clinical Study Manager 4) role will develop and execute strategies for clinical and outcomes research studies to support regulatory approvals and key strategic evidence initiatives. As a member of the Clinical Affairs team, this role will be responsible for working with key stakeholders to design and develop clinical protocols and execute clinical studies (pre-market or post-market studies), with minimal supervision. The candidate will be required to work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, develop clinical study reports, or support the development of clinical publications. During trial execution, the CSM will drive the progress of the trial during site selection, site start-up and through enrollment and follow-up. The CSM will clearly provide guidance to the monitors about monitoring needs, and oversee compliance work on the study. The CSM will also take a leadership role in external communication with investigators and study teams. The ideal candidate will have experience previously managing multi-center, premarket studies in the United States (IDE for 510k or PMA submissions) and utilizing resources to research and scope research topics and to provide recommendations on clinical trial strategy. The candidate is also expected to have experience reviewing, interpreting and summarizing clinical literature.

Essential Job Duties

• Responsible for leading assigned clinical research activities
• Collaborate with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocol and study outlines and subsequently driving identified initiatives
• Responsible for the planning and execution of the clinical studies including site selection, analysis of potential patient recruitment and projections, creation of study related documents (protocols, case report forms, Informed consents, Clinical trial agreements, study reports), organizing IRB/EC submissions with follow-thorough to ensure successful progress
• Responsible for independently conducting clinical studies on schedule and within budget while ensuring high quality and compliance
• Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits.
• Conduct clinical study monitoring to ensure regulatory and protocol compliance as well as overall data accuracy in accordance with the study clinical monitoring plan
• Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a case report form at sites  or in data  listings to ensure regulatory and protocol compliance and overall accuracy
• Liaise with sites and support in internal audit/inspection and ensure sponsor audit readiness
• Liaise with external vendors and sites to negotiate contracts and budgets in collaboration with the legal team and management
• Track study progress and provide regular status reports
• Work closely with Biostatisticians on data analysis, interpretation and synthesis, in order to develop clinical study reports and /or support development of scientific publications
• Track, process and manage site payments and support in study financial tracking by developing tracking tools as necessary
• Organize and lead study meetings and other study activities as assigned
• Mentor junior clinical study manager(s); provide guidance to CRAs and CTAs on monitoring and other study needs
• Follow corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines) and proactively manage studies, following such guidelines and requirements
• Conduct literature searches and familiarize with literature to stay informed and abreast of relevant scientific/clinical knowledge and/or to determine evidence gaps
• Critically appraise scientific literature and write clinical summaries to assist research and the development of clinical strategies and clinical investigational protocols
• Review and revise Clinical Operations Standard Operating Procedures (SOPs) to assist Clinical Affairs leadership with continuous process improvement initiatives
• For post-market research, collaborate with commercial groups (i.e., marketing) to understand market trends and utilize information to support of business goals through Clinical Affairs activities
• For post-market research, provide scientific expertise to the Health Economics and Outcomes Research department for development of outcomes research analysis (including identification of appropriate diagnosis or reimbursement codes, selection of clinical outcomes for procedures of interest)
• Work with clinical investigators to prepare manuscripts, abstracts, slide presentations, and poster presentations for scientific meetings and publications in collaboration with management
• Support regulatory submission and approval of pre-market clinical studies and 510k(s), responsible for addressing regulatory body questions on clinical study design and results (e.g., protocol, ICF, eCRF, clinical study reports).