Sr. Clinical Study Manager

Job Description

Primary Function of Position:

This position reports to a Manager or Sr. Manager, Clinical Affairs and requires a strong candidate with experience supporting evidence generation strategy and execution of industry-sponsored clinical studies and/or registries. A candidate must have some previous experience around understanding clinical literature, clinical research and/or clinical affairs.  The Senior Clinical Study Manager will develop strategies for clinical and outcomes research studies, including those with complex aspects.  For this level, this role will be responsible for working with keys stakeholders to design and develop clinical protocols, and execute clinical studies (pre and/or post market) across a product lifecycle with minimal supervision. The candidate will be required to work closely with data management and biostatistics to review and interpret results of clinical studies and to develop a clinical study report or support the development of clinical publications. The ideal candidate will have experience previously managing clinical studies globally and experience utilizing resources to research and scope a research topic and to provide recommendations on clinical trial strategy. The candidate is also expected to have experience in reviewing, interpreting and summarizing clinical literature as well as knowledge around and experience implementing clinical trial operations.  

Roles & Responsibilities: 

•         Responsible for leading pre and post-market clinical research activities

•         Collaborate with internal stakeholders and KOLs (key opinion leaders) to develop and review study concepts, protocol and study outlines and subsequently driving identified initiatives.  Actively contribute to strategic discussions around clinical affairs activities locally and globally for specific product or procedure areas

•         Conduct literature searches, including systematic searches to stay abreast of scientific knowledge and to determine the evidence gaps.

•         Responsible for the planning and execution of the clinical studies including investigator selection, analysis of potential patient recruitment,  creation of study related documents (including protocols, case report forms, Informed consents, Clinical trial agreements), organizing IRB/EC submissions with follow-through to ensure successful outcome.   Also responsible for overseeing and/or conducting aspects of clinical trial operations (i.e. monitoring and/or data review) as needed

•         Responsible for independently conducting clinical studies on schedule and within budget while ensuring high quality and compliance

•         Liaise with external vendors and sites to negotiate contracts and budgets

•         Track study progress and provide status report on a weekly basis

•         Participate in data analysis, interpretation and synthesis, instruction in order to develop Clinical study reports and/or support development of scientific publications including peer-reviewed manuscripts in partnership with external key opinion leaders

•         Ensure compliance with corporate (e.g., SOPs) and regulatory requirements (e.g., GCP and US and OUS guidelines)

•         Critically appraise scientific literature and write clinical summaries to assist research efforts and 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.

•         Collaborate with commercial groups (i.e. marketing) to understand market trends and utilize information to support of business goals through Clinical Affairs activities

Qualifications

Skills, Experience, Education, & Training:

•         Advanced degree in a scientific/bioengineering field (M.S., Ph. D or M.D.) with at least 3-6 years of experience or Bachelor’s degree in a scientific/bioengineering field with 8-10 years of experience in clinical affairs/research study/project management is preferred

•         Previous experience in implementing, supporting and managing pre and post-market device trials

•         Knowledge of clinical and outcomes research study design is necessary.

•         Experience in conducting literature searches, reviews and appraisal of the scientific data is preferred

•         Experience in protocol development and/or writing clinical section for regulatory submission is required

•         Experience working on global based products or clinical affairs activities in multiple regions preferred

•         Experience working in previous on projects around surgical applications or the  pulmonary space preferred

•         Ability to interact with physicians and other professionals inside and outside the company.

•         Possess knowledge of Good Clinical Practice ICH/GCP, 21 CFR Part 11, ISO 14155 and international regulations.

•         Comfortable in a hospital environment, with experience working with nurses and surgeons

•         Basic understanding of statistics, statistical methods, and design of experiment is a preferred

•         Must have high level of attention to detail and accuracy

•         Must be able to work effectively on cross-functional teams

•         Must be able to travel up to 10-20%

•         Must be able to manage or support multiple projects

•         Strong communication, presentation and interpersonal skills with high attention to detail and organization

•         Ability to learn quickly and self-educate on different or new specialties or therapeutic areas 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 

Additional Information

All your information will be kept confidential according to EEO guidelines.

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 COVID-19.  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.