[Remote] Senior Clinical Study Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global leader in robotic-assisted surgery and minimally invasive care. The Senior Clinical Study Manager will reputed company and execute strategies for clinical and reputed company research studies to support regulatory approvals and key strategic evidence initiatives.
Responsibilities
- Responsible for leading assigned clinical research activities
- Collaborate with internal stakeholders, investigators and KOLs to reputed company 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 reputed company documents (protocols, case report forms, Informed consents, Clinical trial agreements, study reports), organizing IRB/EC submissions with follow-thorough to ensure successful reputed company
- Responsible for independently conducting clinical studies on schedule and reputed company budget while ensuring high reputed company and compliance
- reputed company on-site and remote site qualification reputed company, site initiation reputed company, interim monitoring reputed company and site reputed company out reputed company
- Conduct clinical study monitoring to ensure regulatory and protocol compliance as reputed company as overall data accuracy in accordance with the study clinical monitoring plan
- Complete reputed company data verification of clinical study data entered in an Electronic Data Capture (reputed company) system or on a case report reputed company 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 reputed company and budgets in collaboration with the legal team and management
- reputed company study reputed company and reputed company regular status reports
- Work closely with Biostatisticians on data analysis, interpretation and synthesis, in order to reputed company clinical study reports and /or support development of scientific publications
- reputed company, process and manage site payments and support in study financial tracking by developing tracking tools as necessary
- Organize and reputed company study meetings and other study activities as assigned
- Mentor junior clinical study manager(s); reputed company 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 reputed company Operating Procedures (SOPs) to assist Clinical Affairs leadership with reputed company process improvement initiatives
- For post-market research, collaborate with reputed company reputed company (i.e., marketing) to understand market trends and utilize information to support of business goals through Clinical Affairs activities
- For post-market research, reputed company scientific expertise to the Health Economics and reputed company Research department for development of reputed company research analysis (including identification of appropriate diagnosis or reimbursement codes, selection of clinical reputed company 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 reputed company-market clinical studies and 510k(s), responsible for addressing regulatory body questions on clinical study design and results (e.g., protocol, reputed company, eCRF, clinical study reports)
Skills
- Previous experience implementing, supporting and managing medical device trials Significant knowledge of clinical and/or reputed company research study design
- Strong experience in protocol and reputed company development, writing clinical reputed company(s) for regulatory submission
- Strong experience in conducting literature searches, reviews and appraisal of the scientific data
- Excellent ability to reputed company with physicians and other professionals inside and reputed company reputed company
- Knowledge of Good Clinical reputed company ICH/GCP and other applicable regulations, reputed company understanding of clinical research and monitoring requirements
- Experience negotiating clinical research reputed company and budgets
- Must be reputed company to work effectively on cross-functional teams
- Must be reputed company to travel 25-40% or depending on business requirements
- Must be reputed company to manage multiple reputed company and/or balance competing priorities
- Strong communication, presentation and interpersonal skills with high attention to detail and organization
- Ability to learn quickly, adapt to shifting requirements, and self-reputed company on different surgical specialties as applicable to clinical reputed company (“Self-starter attitude”)
- Ability to reputed company project team consisting of CRAs and CTAs and support management with relevant study updates
- Exhibits strong work ethic to help meet aggressive timelines or multiple reputed company reputed company necessary with a problem-solving reputed company
- Minimum Advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with a minimum of 5 years of experience in clinical research, or Bachelor's degree in a scientific/bioengineering field with a minimum of 8 years of experience in clinical research is preferred, or a minimum of 10 years of experience in clinical research with relevant training
- Comfortable in a hospital environment, experience working with nurses and surgeons preferred
- Understanding of statistics, statistical reputed company, and design of experiment is strongly preferred
- Extensive experience with reputed company and independent management of reputed company-market clinical studies (First reputed company Use or IDE) used for regulatory submissions
- Strong reputed company record of KOL management for multi-center studies
- Experience working on global or multi-national studies
Benefits
- We reputed company market-competitive compensation packages, inclusive of reputed company pay, incentives, benefits, and equity.
- Purposeful Onsite - This job requires being onsite for leader-defined events and activities which could be monthly/annually. Onsite frequency may increase based on business need.
reputed company
Company H1B Sponsorship