Clinical Study Manager

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

**Help us lead on of the world's largest pharmaceutical companies**

In this role you will be managing and monitoring clinical in vitro Diagnostic and / or Medical Device studies for all the IVD product lines, including Inmmunohematology, Immunoessay and Nucleic Acid Test (NAT) worldwide but mostly in US, China and Europe across multiple sites.

**What your responsibilities will be**
- Be responsible and accountable for the management, execution and oversight of the IVD clinical study with particular emphasis on technical quality, timelines, budget, metrics and compliance with the project plans and SOPs.
- Serve as primary sponsor contact for operation, technical study-specific issues and deliverables.
- Develop the plans, tools and training to oversee and assess performance of the clinical trial with the sites and vendors (if applicable)
- Conduct of site visits (on site and remote), including, but not limited to: Feasibility Visits, Site Initiation Visits, Routine Monitoring Visit and Close-out Visits.
- Maintain in depth knowledge of clinical protocol, study binder, clinical process and clinical affairs area.
- Maintain overall responsibility for ensuring the resolution of escalated study conduct issues from investigators, study sites, regulatory authorities and IRBs/ECs.
- Proactively communicate with Product development, Research and Development (reagents and instruments), Quality, Global Compliance, Legal, and other members of the company involved in clinical trials to meet the project timelines.
- Develop, maintain and expand collaborations with external consultants, sites, institutions, investigators and contract service providers to enable practical and smooth clinical study execution including all type of vendors.
- Create, participate and oversee the regulatory, ethics committee and health authorities’ documentations as well as the clinical study protocol, clinical study report or any required document to develop a clinical trial.
- Create and ensure that all study related documents are tracked, filed and reviewed and complete according to the SOPs, regulatory requirements and protocol, including Clinical Plan, Monitoring Plan, Communication Plan and all the associated plans.
- Manage the trial master file/study binder process including ongoing maintenance, accurate filing and administration of QC plan.
- Get and manage all the materials, products, reagents, samples or instruments required for a clinical trial during the entire trial.
- Provides clinical input in the development of case report forms, data management plan, and data listings review. Collaborates with biostatistician/data expert to ensure timely data transfers for data cleaning, review and analysis.
- Detect, reviews, track protocol deviations and data listings to ensure integrity of data and identify trends on ongoing basis.
- Responsible and accountable for understanding and managing the budget for the project, and ensure that the activities are within budget, timelines and scope of work.
- Communicate effectively with all members of the team, investigators, vendors and clients as applicable, to support the study completion per company and client requirements and timelines, including risk identification and mitigation, issue escalation and working with quality and the project team on corrective and preventative actions.
- Perform other duties as required by the department or direct manager as SOP creation, or update.
- Ability to function in the role as Clinical Trial Lead, Senior Clinical Monitor or Project Clinical Lead.

**Who you are**
- You have Bachelor’s Degree in life science. If you have Master’s in clinical trial research or a PhD related can be advantageous.
- You have Knowledge on clinical research experience in Diagnostic, Medical Devices, Pharmaceutical or CRO industries will be considered.
- You have at least 4-7 years of work experience in a regulated in vitro diagnostics industry.
- You have solid track record in successfully executing clinical studies for IVD products.
- You have knowledge and understanding of IVDR and FDA regulations.
- You have thorough knowledge of ICH Guidelines and GCP and understanding of regulatory requirements in other countries.
- You have thorough understanding of the Diagnostic, Medical Device or Drug development process.
- You have good understanding of basic project management of international clinical trials.
- You speak fluent English and you have good communication skills.
- You