Clinical Research Manager at PRA Health Sciences

Position Overview:

As a Clinical Research Manager, you will be dedicated to one of our global pharmaceutical clients; a company that is advancing the development of new medicines, biologic therapies and vaccines for many of the world’s most challenging diseases including cancer, cardio-metabolic diseases, Alzheimer’s and infectious diseases. Be ready to work in a solid partnership and an environment driven by innovation and continuous improvement.

Working fully embedded within the local clinical team at our client’s offices in Romania, the Clinical Research Manager plays a key role in the success of global clinical trials at a local level. The tasks undertaken are varied and can include:

• Accountability for the performance of assigned protocols in a country in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• To be the Country point of contact (POC) for assigned protocols and proactively drive/track execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles.
• Forecasting country resource needs and serving local business needs (sign contracts, manage budgets as delegated)
• Responsibility for quality and compliance of assigned protocols in the country and oversee CRAs and/or CTAs and training compliance.
• Performing quality control visits, reviewing Monitoring Visits Reports and escalating performance issues and training needs to functional vendor and internal management as needed.
• Responsibility for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners.
• Overseeing country and site validations, site selection and recruitment in assigned protocols.
• Responsibility for clinical trial education to sites and act as the country POC for programmatically outsourced trials for assigned protocols.
• Representing the client in Pharma industry issues and in seeking influence in external R&D environment.
• Collaborating internally local Pharmacovigilance and Regulatory Affairs to align on key decisions in countries.
• Supporting local and regional strategy development consistent with long-term corporate needs in conjunction with Regional Operations.

You are:

Proactive, collaborative, innovative. Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

• A previous track record of success in a Clinical Project Management or a Clinical Research Manager role in a pharma company or global CRO.
• Strong understanding of start-up activities, clinical trial planning, (site) management and metrics.
• Strong communication and leadership skills
• Ability to coordinate and lead local teams to high performance and to lead across several dimensions simultaneously.
• Fluent in Afrikaans and English