Lovevery
Lovevery is a company that specializes in providing high-quality play kits designed for children's developmental stages. Each kit includes an original collection of toys and books that support early learning through play, with an emphasis on age-appropriate materials and expert-backed educational resources. Lovevery prioritizes safety and sustainability, ensuring that each product is made from premium natural materials. The company offers free shipping and easy returns, catering to parents seeking engaging and educational play experiences for their children.
Clinical Operations Program Manager
March 12
Lovevery
Lovevery is a company that specializes in providing high-quality play kits designed for children's developmental stages. Each kit includes an original collection of toys and books that support early learning through play, with an emphasis on age-appropriate materials and expert-backed educational resources. Lovevery prioritizes safety and sustainability, ensuring that each product is made from premium natural materials. The company offers free shipping and easy returns, catering to parents seeking engaging and educational play experiences for their children.
📋 Description
• Manage and execute sponsor-initiated and third-party studies • Operational oversight of all study phases from development to close out • Work closely with cross-functional teams to ensure project alignment • Develop applicable study related documentation • Develop study budgets with internal and external functions • Identify and propose risk mitigation regarding challenges • Establish relationships and collaborate with study site personnel • Oversee data management for accurate and timely data collection • Participate in safety monitoring and review reports • Maintain accurate and complete study documentation • Prepare for regulatory audits and inspections • Support clinical related activities for Regulatory submissions • Provide management updates on clinical operational aspects • Collaborate on development of Department SOPs
🎯 Requirements
• 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 • 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 • Ability to work independently on routine assignments, or with limited supervision on new assignments • 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)
🏖️ Benefits
• 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
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