Primary Function of Position
As the regional clinical affairs leader, this role is responsible for developing and implementing evidence strategies, including but not limited to; company sponsored studies, IIT (Investigator Initiated Trials), society driven registries, RWE analysis (Real world Evidence). Responsible for designing and executing evidence strategies 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. Develop and support all clinical and medical affairs needs of the company with the applicable local guidelines and regulations.
Essential Job Duties
- Responsible for monitoring publication landscape to stay abreast of scientific knowledge and market trends through regular review of scientific literature to help develop clinical evidence strategies
- Identify evidence gaps and market opportunities to design and execute evidence strategies to meet local evidence needs and to support reimbursement initiatives
- Contribute to the development and implementation of clinical and medical strategies to meet business goals and objectives. Responsible for conducting evidence generation initiatives (company sponsored studies, IIT (investigator initiated trials) , society driven registries , RWE (Real World Evidence) analysis ) on schedule and within budget while ensuring high quality and compliance
- Collaborate with commercial function to understand market trends and utilize information to support of business goals through Clinical Affairs activities
- Collaborate with key internal stakeholders such as Regulatory Affairs (RA), Global Access Value Economics (GAVE), Global Public Affairs (GPA), Commercial functions and external stakeholders such as advisory boards, KOLs, and various medical/surgical societies to develop evidence generation strategies, to review evidence concepts, to develop study/evidence designs and subsequently to implement these initiatives
- Responsible for overseeing the planning and execution of site selection, 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 to develop Clinical study report and /or support development of scientific publications
- Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements.
- Author, review and revise Clinical Operations Standard Operating Procedures (SOPs) for the region/country
- 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
Required Skills and Experience
- Previous experience supporting development of scientific publication strategy
- Significant knowledge of clinical and outcomes research study design
- 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
- 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
- Must be able to work effectively on cross-functional teams and in a matrix environment
- 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
- Should be able to understand business needs and be able to work in a matrix environment to deliver objectives, should be self-driven and proactive
- Strong understanding of country healthcare systems
- Entrepreneurial mindset, ability to take risks
- Must be able to travel 20%-35%(predominantly within region)
Required Education and Training
- Advanced degree in a scientific/bioengineering field (Ph. D or M.D.) or Master’s degree in a scientific/bioengineering field with 10+ years of experience in clinical affairs/research project/medical affairs management is preferred
Preferred Skills and Experience
- Preference given to candidates with existing experience or familiarity with surgery/surgical technology
