(BT-650) - Clinical Trial Monitor

(BT-650) - Clinical Trial Monitor

29 ago
|
Bristol Myers Squibb
|
Metropolitana

29 ago

Bristol Myers Squibb

Metropolitana

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Responsible for the oversight of the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

Act as one of the points of contact at a Hub level for internal and external stakeholder.+ 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 (, 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.+ Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor. Includes site monitoring activities for pharmacy, randomization review, drug accountability, and reconciliation of the blinded investigational products. Work with Unblinded study staff including pharmacists or Unblinded drug preparers and communicate only with internal BMS Unblinded study personnel during the study conduct.+ 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 and/or SMP+ 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.+ Involvement in 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.+ Proactively identify and resolve potential problems at both site and country/hub level.+ Engage with STM and/or line management to assist in the resolution of more complex issues.+ Proactively seek to enhance communication skills with both internal (Global level) and all relevant external parties and coaches others to do the same.+ Contribute significantly to study team and coaches site staff to enhance site and hub performance.+ Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations.+ Assist management in various tasks, as assigned or requested+ Bachelors or Master degree "preferably" within life sciences area? or applicable scientific and/or clinical knowledge.Experience requirement: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.Associate Clinical Site Monitor - 1 year of relevant Clinical Research Development Experience.Clinical Site Monitor - 2-3 years of relevant clinical research development experience, able to work independently.Senior Clinical Site Monitor - At least 5 years of monitoring experience. Demonstrate leadership skill, mentor and coach capability. Can be delegated Site Monitor Manager activities as SME. Any Prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinatorKey Competency Requirements: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? (experience with audits and Inspection experience desirable).Has current knowledge and understanding of appropriate therapeutic indications ?Knowledge of 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).Ability to work on multiple protocols simultaneously.Negotiation and influencing skills. Flexible/adaptable to changing priorities.Strong relationship (internal and external) management.Travel requirement: Travel to clinical trial sites in support of clinical research where required.Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.**Company:** Bristol Myers Squibb**Req Number:** R1542120**Updated:** 2021-08-27 01:22:40.403 UTC**Location:** Santiago,Chile

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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