Senior Clinical Study Manager

Senior Clinical Study Manager

Requirements

• Previous experience implementing, helping and managing medical device trials
• Significant knowledge of clinical and/or outcomes research study design
• Proven experience in protocol and ICF development, writing clinical section(s) for regulatory submission
• Proven experience in conducting literature searches, reviews and appraisal of the scientific data
• Excellent ability to interact with physicians and other professionals inside and outside the company
• Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
• Experience negotiating clinical research contracts and budgets
• Must be able to work effectively on cross-functional teams
• Must be able to travel 25-40% or based on business requirements
• Must be able to manage multiple projects and/or manage different priorities
• Proven communication, presentation and relational skills with high attention to detail and organization
• Ability to learn quickly, tailor to shifting requirements, and self-educate on different surgical specialties as applicable to clinical projects (“Self-starter attitude”)
• Ability to drive project team consisting of CRAs and CTAs and support management with relevant study updates
• Exhibits solid work ethic to help meet tight timelines or multiple projects when necessary with a problem-solving mindset

Responsibilities

• Accountable for leading assigned clinical research activities
• Partner with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocol and study outlines and subsequently driving identified initiatives
• Accountable for the planning and execution of the clinical studies including site selection, review 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
• Accountable for autonomously 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 help in internal audit/inspection and ensure sponsor audit readiness
• Liaise with external vendors and sites to negotiate contracts and budgets in partnership 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 help development of scientific publications
• Track, process and manage site payments and help in study financial tracking by developing tracking tools as necessary
• Organize and drive 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 establish 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, partner with commercial groups (i.e., marketing) to know about market trends and utilize information to help 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 review (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 partnership with management
• Help regulatory submission and approval of pre-market clinical studies and 510k(s), accountable for addressing regulatory body questions on clinical study design and results (e.g., protocol, ICF, eCRF, clinical study reports)

Preferred Qualifications

• Accustomed to working in a hospital environment, experience working with nurses and surgeons preferred
• Knowledge of statistics, statistical methods, and design of experiment is highly preferred