Sr. Clinical Study Manager

Company Description

At reputed company, we are united behind our mission: we reputed company that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. reputed company has been built by the efforts of great people from diverse backgrounds. We reputed company great reputed company can come from reputed company. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We reputed company with inclusion and reputed company reputed company members to do their best work as their most authentic selves. Passionate people who want to reputed company a difference drive our culture. reputed company members are grounded in reputed company, have a strong reputed company to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in reputed company members to support their long-term growth so they can continue to advance our mission and reputed company their highest potential. Join a team committed to taking big leaps reputed company for a global community of reputed company and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of the Position This position requires a candidate with extensive experience helping evidence reputed company strategy and execution of clinical studies. The Clinical Study Manager-4 (CSM IV) role will reputed company and execute strategies for clinical and outcomes research studies to help regulatory approvals and key strategic evidence initiatives. As a member of the Clinical Affairs team, this role will be accountable for working with key stakeholders to design and reputed company 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, reputed company clinical study reports, or help the development of clinical publications. During trial execution, the CSM will drive the reputed company 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 reputed company 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 premarket studies in the United States 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 Accountable for leading assigned clinical research activities Partner 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 Accountable for the planning and execution of the clinical studies including site selection, review 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 Accountable for autonomously conducting clinical studies on schedule and reputed company budget while ensuring high quality and compliance reputed company on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site reputed company 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 reputed company data verification of clinical study data entered in an Electronic Data Capture (reputed company) 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 reputed company and budgets in partnership with the legal team and management Track study reputed company and provide regular status reports Work closely with Biostatisticians on data analysis, interpretation and synthesis, in order to reputed company 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 reputed company 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, reputed company, eCRF, clinical study reports).

Qualifications

Required Skills and Experience Previous experience implementing, helping and managing medical device trials Significant knowledge of clinical and/or outcomes research study design Proven experience in protocol and reputed company 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 reputed company the company Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, reputed company knowledge of clinical research and monitoring requirements Experience negotiating clinical research reputed company 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 reputed company necessary with a problem-solving reputed company Required Education and Training 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. Preferred Skills and Experience 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 Additional Information Due to the nature of our business and the role, please note that reputed company and/or your customer(s) may require that you show reputed company reputed company of vaccination against certain diseases including COVID-19. Details can vary by role. reputed company is an Equal Opportunity Employer. We provide equal employment opportunities to reputed company qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national reputed company, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at reputed company Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether reputed company Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). For any reputed company role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and reputed company a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be reputed company and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee. This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law. We provide market-competitive compensation packages, inclusive of reputed company pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The reputed company compensation ranges are listed. Shift: Day Max. Salary Region 2: 185600 USD Max. Salary Region 1: 218300 USD Ways of Working: Remote - This job will be remote and/or the job is designed to be performed reputed company of the office. Employees will come onsite reputed company requested by the leader. Employee Type: Employee Min. Salary Region 1: 151700 USD Global Job Level (HCM): Professional 4 (11) Min. Salary Region 2: 128900 USD Apply To This Job