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
- Oversee 3rd parties and/or clinical research organizations (CROs), as applicable
- Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits
- Conduct clinical study monitoring and/or oversee CRAs 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
- Drive cross-functional alignment with teams including but not limited to: Medical Officers, Medical Affairs, Clinical Research/Development Engineering, Regulatory and Market Acess
- 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)
Team
Structure: Member of the Clinical Affairs team; works with clinical research associates (CRAs), clinical trial assistants (CTAs), biostatisticians, Medical Officers, Medical Affairs, Clinical Research/Development Engineering, Regulatory, Market Access, and commercial groups. May mentor junior clinical study managers.
