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ICON plc logo
ICON plc

ICON plc, or simply ICON, is a global provider of outsourced development services to companies in industries like biotechnology, medical devices, and pharmaceut

Clinical Study Manager

Location

Kenya

Posted

68 days ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglish

Job Description

Clinical Study Manager

ICON plc

• Lead the end-to-end management of medical device clinical studies across multiple regions • Oversee study timelines, deliverables, and budgets, ensuring operational excellence • Collaborate with and manage CRO partners to ensure effective study execution • Contribute to protocol development, including defining study endpoints and methodology • Ensure compliance with applicable regulatory requirements, with a strong focus on medical device regulations • Manage submissions to ethics committees and relevant regulatory bodies • Oversee study documentation, including Trial Master File quality and end of study reports • Provide regional oversight across Africa and India, including on-site engagement as required

Job Requirements

  • Bachelor's degree in a relevant field
  • Minimum of 3 years of experience in clinical trial management
  • Proven experience managing medical device clinical studies from start-up through close-out
  • Strong understanding of medical device regulatory requirements and submission processes
  • Experience working with CROs and managing external vendors
  • Hands-on experience writing or contributing to clinical study protocols and endpoints
  • Track record of submitting to ethics committees and preparing end of study documentation
  • Experience working across Africa and or India regions is highly desirable
  • Willingness and ability to travel extensively within the region
  • Effective communication and interpersonal skills, with the ability to collaborate across diverse teams.
  • Detail-oriented and organized, with a track record of successfully managing multiple tasks and priorities simultaneously.

Benefits

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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Empowering all who serve children with diverse needs

Full TimeRemoteTeam 51-200Since 2009H1B Sponsor

CRA II Location: Morrisville United States Job Description: Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. 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Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787). Let’s realize your potential, together. 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