Primary Location: India-Bangalore-Bengaluru
Requisition ID: 200194
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As a lead regional clinical affairs employee , this role is responsible for developing and implementing clinical strategies , designing and executing clinical studies across surgical specialties and various product platforms. This role is responsible for driving the development and implementation of clinical research/evidence generation strategies to meet business goals and objectives .This role will be responsible for executing clinical studies ( company sponsored and investigator initiated ) in support of clinical publications, presentations, abstracts and posters in support of key scientific research and publication needs. Oversee and manage communications with clinical trial sites, CROs, KOLs and medical societies. Develop and support all clinical requirements of the company with the applicable local guidelines and regulations.
Roles and Responsibilities:
• Responsible for monitoring publication landscape to stay abreast of scientific knowledge and market trends through regular review of scientific literature in order to help develop clinical evidence strategies
• Identify evidence gaps or market opportunities to design and execute clinical trials and outcomes research evidence studies with minimal supervision
• Contribute to the development and implementation of clinical research strategies to meet business goals and objectives.
• Collaborate with commercial groups (i.e. marketing) to understand market trends and utilize information to support of business goals through Clinical Affairs activities
• Collaborate with key internal stakeholders such as commercial orgnization and external stakeholders such as advisory boards and KOLs to develop study strategies and review study concepts, protocol and study outlines and subsequently driving identified initiatives
• Work closely with clinical investigators, clinical affairs HQ team to cover all aspects of clinical trial development and execution. .
• Responsible for conducting clinical studies on schedule and within budget while ensuring high quality and compliance.
• Responsible for the planning and execution of the clinical studies including investigator selection, analysis of potential patient recruitment, supporting the creation of study related documents (including protocols, case report forms, Informed consents, Clinical trial agreements), organizing IRB/EC submissions with follow thorough to ensure successful outcome
• Participate in data analysis, interpretation and synthesis, instruction in order to develop Clinical study report and /or support development of scientific publications.
• Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP in India )
• Author, review and revise Clinical Operations Standard Operating Procedures (SOPs) for the region.
• Provides in-depth understanding of the importance of metrics and milestones
• Responsible for managing budgets and other resources in a consistently effective and efficient manner
• Routinely solves complex problems that enable the team to make significant progress
Competency Requirements: (Competency is based on: education, training, skills and experience.)In order to adequately perform the responsibilities of this position the individual must:
• Advanced degree in a scientific/bioengineering field (Ph. D or M.D.) or Master’s degree in a scientific/bioengineering field with 5-7 years of experience in clinical affairs/research project management is preferred
• Previous experience supporting development of scientific publication strategy
• Significant knowledge of clinical and outcomes research study design is necessary.
• Strong 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.
• Strong experience in protocol development and medical writing
• Possess knowledge of Good Clinical Practice and 21 CFR Part 11 and Indian regulations.
• Comfortable in a hospital environment, with experience working with nurses and surgeons
• Strong understanding and background of clinical trials , study design and some formal ICH/GCP knowledge and training
• Basic understanding of statistics, statistical methods, and design of experiment is a requirement
• Must be able to work effectively on cross-functional teams.
• Must be able to travel up to 30-40%
• Must be able to manage multiple projects
• Strong communication, presentation and interpersonal skills with high attention to detail and organization
• Ability to learn quickly and self-educate on different surgical specialties as applicable to clinical projects (Self-starter attitude)
• Consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary
• Preference given to candidates with existing experience or familiarity with surgery/surgical technology