Bristol Myers Squibb CLINICAL SITE MONITOR (SMN) in Madrid, Spain
Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders. Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials. Documents the visit, and communicate findings. Provides feedback on Potential Site Assessment findings to collaborators
Recommends sites during the site feasibility and/or site selection process.
Develops new sites, who have minimal research experience, by providing support in understanding the requirements to run clinical trials (i.e. SOPs, Training, Staff resources etc.)
Determines the need and/or type of pre-study visit that is required depending on the site’s previous experience with running BMS clinical trials
Conducts initiation visits in collaboration with other study team members and ancillary functional groups. Provides protocol specific and individualized training based on the Investigator and site personnel experience, prior to site activation
Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, BMS PBPDs and best practices, protocol, ICH/GCP Guidelines and other local regulations as applicable
While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions. Identifies Key factors and the relative significance of a problem. Analyze root cause and potential bias. Seeks for appropriate input and creates a corrective and or / preventive action plan and communicate the process in a logical and timely manner
Performs site closure activities when all required protocol visits and follow-up are completed
Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
Ensures quality of data submitted from study sites and assures data currency by using the available systems to follow site activities.
Clinical Data Listing review is performed at the assigned timepoints according to the Data Review Plan
Supervises overall activities of site personnel over whom there is no direct authority.
Motivates/influences the site to meet study objectives, including enrollment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method
Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented
Facilitates the Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions
Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
Builds, cultivates and maintains customer relationships and identifies synergies between customer needs and the company’s interests
Builds trusts with customers by serving as a consistent and accurate resource
Experience in site monitoring and site management.
Experience in the drug discovery/development process.
Experience in planning, preparing and submitting IRB document (where applicable)
Experience in using Microsoft suits, EDC and electronic Clinical Trial Management Systems.
Experience in site facing role, using multiple communication tools and skills (as applicable)
Experience in planning and organizing multiple tasks. Work effectively in a dynamic environment with competing projects and deadlines.
2-3 years of relevant clinical research development experience
Has a thorough knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials.
Understands the application of regulatory requirements by clinical institutions and IRBs/IECs that ensure proper conduct of the study
Has current knowledge and understanding of appropriate therapeutic indications
Experience with Risk Based Monitoring methodology
Understands the drug development process, from early to late stage, including lifecycle management
Knowledgeable of scientific and medical principles which allow for understanding of concepts such as drug mechanism of action, drug interactions, safety concerns, disease and treatments of standard practice under study
Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
Understands Health Authority inspection and sponsor audit processes and is able to guide site and provide meaningful responses to findings when appropriate
Fluent in English (oral and written)
We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.