Clinical Site Monitor

Clinical Site Monitor

Bristol-Myers Squibb

Braine L'Alleud, Belgium

Functional Area Description

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 Site level for internal and external stakeholders.

Position Summary/Objective

  • Monitors study sites following the monitoring plan, BMS SOPs, protocol, ICH/GCP Guidelines and other local regulations as applicable. This includes, but is not limited to managing multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory;
  • Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH/GCP Guidelines and local régulations;
  • Orients and trains site personnel regarding the protocol, study related processes and procedures and applicable regulatory requirements;
  • Reviews site activities and quality through on-site visits in addition to remote management capabilities;
  • Ensures quality of data submitted from study sites and assures timely submission of data by using the available systems to follow site activities;
  • Supervises overall activities of site personnel over whom there is no direct authority. Motivates/influences them to meet study objectives, including enrollment and retention goals;
  • Resolves study site problems/issues as they occur. More complex issues may be resolved jointly with management. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective actions are implemented.

Position Responsibilities

  • Identifies new potential Investigators, through ongoing collaborations with medical monitors (including local staff), field medical personnel, and other medical contacts. Assess potential Investigators and their sites. Documents the visit, and communicate findings. Provides feedback on Potential Site Assessment findings to collaborators;
  • Recommends sites for consideration in future studies, as needed;
  • Expedites the pre-study and study initiation processes including the conduct of Pre-Study Evaluation and Site Initiation visits. Conducts initiation visits in collaboration with Clinical Site Managers, Field Medical and/or Protocol Managers;
  • Facilitates the Regulatory Compliance audit process, as needed;
  • Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner;
  • Ensures documented follow-up to all outstanding issues/corrective actions, within the scope of this position profile, in the available systems. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team;
  • Identifies opportunities to interact, builds and strengthens professional and collaborative relationships with all internal and external stakeholders (e.g., site and institutional personnel, Thought Leaders, internal colleagues, etc.);
  • Uses multiple technologies to maintain open and frequent communication with all stakeholders;
  • Exhibits flexibility and adaptability when facing change;
  • Employs good fiscal management for travel expenses, etc.;
  • Ability to perform site management activities, as required;
  • Performs other tasks, as assigned or requested by line manager.

Degree Requirements

  • Knowledge equivalent to that attained with a Bachelor’s degree in Life Sciences, Pharmacy, Nursing and clinically related or relevant experience.

Experience Requirements

  • Minimum of 1, 4 or 6 years' industry related experience (Associate SMN, SMN, Senior SMN);
  • 2-5 years of clinical or developmental experience, of which at least 0-1 year must be clinical research monitoring.

Key Competency Requirements

  • Has a thorough knowledge of ICH/GCP Guidelines and applicable local regulations. Has direct work experience in the drug discovery/development process;
  • Has current knowledge and understanding of appropriate therapeutic indications and Health Authority (HA) regulations as they relate to the conduct of clinical trials;
  • Possesses entry-level skills in the on-site monitoring of investigational drug trials, as confirmed by line manager assessments and Regulatory Compliance audit results, if applicable;
  • Demonstrates the initiative and skills to remain current on recent advances in medicine and medical technology;
  • Has competence in the use of personal computers (use of standard business based applications);
  • Uses good communication skills to effectively communicate with internal and external stakeholders;
  • Exhibits good observational skills, analytical and conceptual capabilities;
  • Exhibits attention to detail, has strong interpersonal skills, excellent verbal and written communication in local language as well as a proficient level of verbal and written English (if not native language);
  • Exhibits effective planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines;
  • Has demonstrated ability to work independently with oversight by line manager;
  • Is able to function independently in addition to coaching other team members.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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