Senior Clinical Study Manager

Primary Function of the Position

This position requires a candidate with extensive experience helping evidence generation strategy and execution of clinical studies. The Clinical Study Manager4 (CSM IV) role will develop 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 responsible for working with key stakeholders to design and develop clinical protocols and execute clinical studies (premarket or postmarket 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 help the development of clinical publications. During trial execution the CSM will drive the progress of the trial during site selection site startup and through enrollment and followup. 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 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

• Responsible 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
• Responsible for the planning and execution of the clinical studies including site selection assessment 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 followthorough to ensure successful progress
• Responsible for autonomously conducting clinical studies on schedule and within budget while ensuring high quality and compliance
• Perform onsite 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 run 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. SOPs) 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 postmarket research partner with commercial groups (i.e. marketing) to recognize market trends and utilize information to support of business goals through Clinical Affairs activities
• For postmarket research provide scientific expertise to the Health Economics and Outcomes Research department for development of outcomes research insights (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 premarket 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).

Qualifications :

Required Skills and Experience

• Previous experience implementing helping and managing medical device trials Significant knowledge of clinical and/or outcomes research study design
• Solid experience in protocol and ICF development writing clinical section(s) for regulatory submission
• Solid 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 expertise of clinical research and monitoring requirements
• Experience negotiating clinical research contracts and budgets
• Must be able to work effectively on crossfunctional teams
• Must be able to travel 2540% or based on business requirements
• Must be able to manage multiple projects and/or prioritize different priorities
• Exceptional communication presentation and social skills with high attention to detail and organization
• Ability to learn quickly adjust to shifting requirements and selfeducate on different surgical specialties as applicable to clinical projects (Selfstarter attitude)
• Ability to guide project team consisting of CRAs and CTAs and support management with relevant study updates
• Exhibits excellent work ethic to help meet tight timelines or multiple projects when necessary with a problemsolving mindset

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 Bachelors 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

• Comfortable in a hospital environment experience working with nurses and surgeons preferred
• Understanding 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 Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19. Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

We provide marketcompetitive compensation packages inclusive of base 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 target salary ranges are listed.

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

EEO and AA Policy

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.

We provide marketcompetitive compensation packages inclusive of base 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 target salary ranges are listed.

Remote Work :

No

Employment Type :

Fulltime