Roche – At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity.
Job Ref: 202010-126894
- Country Study Specialist, Nigeria will function as a subject matter expert on clinical research-related activities in Nigeria and the West African region.
- This role will collaborate with other clinical research stakeholders and serve as a leader for local process improvements and patient recruitment strategies.
- This role will report to the Clinical Operations Lead for Sub-Sahara Africa.
The role entails the following responsibilities:
- Develop collaborations with key identified sites that could partner with Roche in clinical trial projects.
- 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.
- Oversees project, protocol, site feasibility and determine site selection and patient recruitment strategies. Develops country/regional level study timelines and ensures that milestones are set and managed for the overall studies delivery.
- Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start-up activities. Develops local scenario plans that deliver the studies on time, with the most efficient use of budget and resources.
- 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. Ensures monitoring reports are timely, reviewed and takes appropriate actions for follow up on-site issues.
- 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. Ensures that trial management tracking tools (e.g. CTMS/CTP) and systems are populated and maintained.
- Is accountable for all local CCO regulatory, ethical and administrative submissions
- Responsible for ensuring site-level contracts are completed.
- Design and implement a country level training plan to ensure that team members and investigators receive training on the protocol, ICH/GCP requirements, and applicable Roche process/procedures.
- 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 able to prioritize and make decisions.
- Highly self-motivated; able to lead initiatives with authority.