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Job Description

Job Description: The Clinical Development Lead will primarily focus on study design strategy for the development of clinical study protocols and support the clinical operations team with study execution. This person will apply epidemiology principles and methods to the clinical setting to support evidence generation across the businesses for the purpose of improving prevention, diagnosis, and prognosis of diseases in patients.

Key Responsibilities:

• Provide strategic guidance on the design and development of clinical study protocols, including retrospective and prospective data collection methodologies

• Support the design and execution of key elements of the Clinical Development Plan and associated data collection activities, within the business group

• Defining clinical questions, study end-points, identifying relevant evidence, critically apprising evidence, and applying evidence to substantiate clinical and medical device claims

• Identify innovative methods to improve efficiency of collecting evidence and assessing risk of bias

• Collaborate on, or lead where appropriate, calls with regulatory agencies (FDA, EMA) to support clinical trial regulatory submissions

• Liaise with other functions to enable quality clinical study execution as the study design subject matter expert

• Collaborate with the clinical study team in site identification and selection, and provide assistance with study start-up activities

• Participate in Investigator meeting planning and execution and/or on-site initiation meetings

• Serve as internal Principal Investigator on customer sponsored studies where needed

• Support CRAs/CROs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. Engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.

• Contribute to statistical methodologies to validate study objectives

• Contribute to authoring of manuscripts, conference presentations, and other dissemination activities

• Review and synthesize scientific literature and competitive intelligence to support study and program strategy

• Manage timelines and communication to ensure deliverables and milestones are met.

• Acquire or possess in-depth knowledge of competitor devices, state-of-the-art, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.

• Comply with Good Documentation Practices to ensure quality and accuracy of document content and format

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

Compensation: $64 USD hr. to $72 USD hr. Exact compensation may vary based on several factors, including skills, experience, and education

Benefit packages for this role will start on day one of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401K retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

Qualifications:

• Advanced scientific degree (M.S., MPH, Ph.D., or similar degree) in the health sciences, life sciences, clinical sciences or biomedical engineering

• 2+ years of experience in the design and execution of clinical or medical device studies, including retrospective and prospective designs, multi-site clinical investigations, and survey research.

• Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation

• Experience and skill performing systematic medical/ scientific literature searches (PubMed, Google Scholar, etc.)

• Ability to clearly communicate to internal and external stakeholders orally and in writing, including management, academicians, clinicians, and scientists

• Excellent English written and oral communications skills-- strong attention to detail related to consistency, grammar, syntax, and accuracy

• Demonstrated ability to work in a (virtual) team environment, including leading discussions and presenting to internal business and regulatory stakeholders

• Project/timeline management skills and organizational skills

• Ability to prioritize and manage multiple projects and adapt to change as needed

• Self-starter attitude with ability to learn quickly and self-educate on different medical device products and procedures; ability to work independently with minimal supervision

• Strong familiarity with Microsoft Office Preferred Qualifications:

• Knowledge and experience with EN ISO 14155 Clinical Investigations is a plus

• Knowledge and experience with ISO14971 Risk Management is a plus

• Prior knowledge and experience with patient monitoring devices is a plus

Knowledge in medical device regulation and standards is a plus.