Country & Study Start-up (SSU) Manager, Kenya
Job Type Full Time
Job Field Administration / Secretarial
Country & Study Start-up (SSU) Manager, Kenya who will function as a subject matter expert on all SSU and Clinical Trial Management related activities in the country/region, oversees and leads SSU activities in collaboration with other clinical research stakeholders and serves as a leader for local/global SSU process improvements and patient recruitment strategies. As a Country Study Manager, this role will provide direction and leadership to one of more local study teams (LSTs).
The Role Entails The Following Responsibilities
- Coordinate guide and assist with all study start up activities prior to site activation.
- Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation.
- Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up activities.
- Assist with label preparation and approval (local label representative) for studies in collaboration with local regulatory department.
- Track metrics and study start-up timelines to identify trends and opportunities for improvement
- Negotiate contracts and study budgets with sites during the study start-up phase to ensure finalization.
- Establishes Study Timelines, Budget, Resource, Risk and Quality Plans
- Manages the Delivery of Study Activities in Order to Meet Study Plans
- Is accountable for all local CCO regulatory, ethical and administrative submissions
- Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders, e.g.
- Pharma Business, GSM, functional management
Who You Are
- You are passionate about the impact on patients you can have, you are playful with the uncertainty the dynamics of the country served will bring whilst you will stay your course towards the long-term vision? You are a self-starter and energized by new learning opportunities the cultural and market environment will provide you? Then you are the individual we look for. In order to set you up for success you require the following qualifications, Mindset and Behaviors
- University degree or equivalent in a medical/science-related field and or 5 years proven experience in Clinical
- Research Management or related industry.
- Proven clinical development experience on the operational aspects of conducting clinical studies including vendor/CRO management, leading/working as part of a development team, implementing clinical development plans and coordinating study level activities to deliver data for filing or publication purposes including interaction with local Business Units.
- Experience in project management including implementation of risk management plans and management of complex study budgets and resourcing plans.
- International travel required.
- Good stakeholder management and the ability to effectively collaborate across a global organization.
- Ability to influence, act as a change agent, build consensus and manage conflict in challenging situations.
- Ability to work as part of a team.
- Strong verbal and written communication skills.
- Excellent listening and decision making skills.
- Well-organized, detail oriented professional and ability to prioritize and make decisions.
- Highly self-motivated; able to lead initiatives with authority.
- Are you inspired and energized by the opportunity to co-create the future of patients in Kenya and the East African region? If yes, then make your mark and apply to this exciting opportunity!
Roche is an equal opportunity employer.
Research & Development, Research & Development > Clinical Operations
MODE OF APPLICATION
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Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims for improving patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology; Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.