Position: Country Study Specialist
Our Client, a leading Multinational Pharmaceutical company is looking to hire an experienced Country Study Specialist to function as a subject matter expert on clinical research related activities in Nigeria and the West African region
- Develop collaborations with key identified sites that could partner with the Client in clinical trial projects.
- 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.
- 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 process/procedures.
- 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 influcence, 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.
Please send CV in WORD FORMAT to email@example.com with Job title as Subject of the mail.
If you meet the requirements above and you will be contacted shortly after.