Owlet is changing the world of parenting with meaningful products that truly make a difference for millions around the world. Owlet has helped more than a million parents keep their children safe, while bringing joy and sleep to the parenting journey. We believe every parent deserves the peace of mind that comes with a better understanding of their baby’s needs.

As Clinical Operations Program Manager, you have the knowledge and skills to lead and manage the execution of clinical studies within an assigned clinical program, supporting clinical strategy in close collaboration with the VP of Clinical. The Clinical Operations Program Manager will oversee the operational execution of clinical trials including supervising all aspects of clinical trial conduct from site selection and start-up through data collection, monitoring, and study closure ensuring the adherence to study protocols, GCP guidelines, and applicable regulatory requirements. This is a fantastic opportunity for a candidate with a strong background in clinical research and clinical operations management interested in advancing the organization objectives and supporting departmental growth and development. A successful candidate will be a motivated self-starter, with a positive attitude, adaptable to changing work demands, who thrives in a fast-paced environment.

Learn more about our amazing mission at https://owletcare.com/pages/why-owlet

PRIMARY RESPONSIBILITIES:

• Responsible for the management and execution of sponsor-initiated and third-party studies as assigned in compliance with quality standards (including ICH GCP, local regulations and company SOPs), on schedule and on budget.
• Operational oversight of all study phases spanning development, start-up, site management, monitoring, and study close out:
• • Work closely with cross-functional team members such as product, quality, legal, data science, marketing, customer service and sales to ensure project alignment.
  • Provide input into the selection, qualification, and oversight of research partners including study sites, CRO, central laboratories and other vendors as applicable to meet business objectives.
  • Develop all applicable study related documentation (e.g., protocol, informed consent, and monitoring-, safety- and data-management plans, etc.).
  • Develop study budgets with internal and external functions and participate in the review of site contracts and budget negotiations.
  • Develop project schedules, enrollment projections, and manage timelines and budgets.
  • Identify and propose risk mitigation regarding enrollment challenges or other clinical operational aspects.
  • Establish relationships with study site personnel and collaborate with the investigative sites on operational aspects of clinical studies ensuring study compliance and timely execution.
  • Oversee data management for accurate and` timely data collection, data quality review, data cleaning, and database lock in collaboration with data manager and statistician.
  • Participate in safety monitoring and/or review reports ensuring proper capture, follow-up, and reporting of adverse events (AEs).
  • Maintain accurate and complete study documentation and maintenance of the TMF.
  • Participate in study progress and/or final report generation.
  • Prepare for and support regulatory audits and inspections.
• Support clinical related activities for Regulatory submissions (e.g., FDA) such as pre-clinical studies, IDE, 510(k), etc.
• Provide management updates on the clinical operational aspects of the clinical studies as regular dashboards or presentations as required.
• Collaborate on the development of Department SOPs, as required.

REQUIRED SKILLS AND QUALIFICATIONS:

• Bachelor’s degree (or equivalent) in biomedical, life science or related field.
• Minimum of 6 years of work experience in the biotech, pharmaceutical or medical device industry and/or CRO.
• Minimum of 2 years of experience in clinical trial operations or clinical project/program management in one of the following areas: sponsor-initiated trials and/or medical device studies or programs.
• Strong competency in FDA regulations governing clinical trials and human subject protection (21 CFR) and ICH GCP guidelines.
• Proficiency in clinical trial management systems and electronic data capture (EDC)
• Excellent written and verbal communication, interpersonal and organizational skills, and ability to prioritize.
• Ability to build relationships within the team, across departments, and with external contacts.
• Proven ability to take ownership, solve problems proactively, and deliver results in a dynamic environment including:
• • Proactively identify and resolve/escalate project-related operational issues.
  • Ability to work independently on routine assignments, or with limited supervision on new assignments.
  • Develop project timelines, deliverables, and maintain schedules.
• Familiarity with word processing, spreadsheet and document management systems.
• Preferred: Experience in digital health or wearable technology highly desirable
• Preferred: Clinical research certification such as CCRP (SOCRA) or CCRC (ACRP)

PERKS:

• Competitive compensation based on experience
• Flexible schedules
• Paid holidays
• Product discounts
• 401(k) Match
• Eligible for company-sponsored benefits package 1st day of the month, following your hire date

Owlet Baby Care, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.