Clinical Trial Monitor
Bristol-Myers Squibb
Taipei,Taiwan
1天前

Bristol-Myers Squibb is a global Biopharma company committed to a single mission : to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development.

Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Division

Regional Clinical Operations- Korea & Taiwan, JKT hub

Functional Area Description

Regional Clinical operations department is responsible for a critical component in all studies. From start-up to close-out, our highly skilled clinical operations teams ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsors.

Position Summary / Objective

  • Responsible for the oversight of the progress of a clinical trial, reviewing site activities through on site and off site monitoring per monitoring plan and 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).
  • Build the collaborative relationship with all study personnel and peers as well as customers
  • 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. 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. 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 regulations.
  • 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.

  • 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.

  • 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.
  • 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

    Possesses knowledge typically attained through at least a Bachelor’s degree (or local equivalent) in a health related field

    Experience Requirements

  • Entry level monitoring skills and skills in management of sites.
  • Has direct work experience in the drug discovery / development process.
  • 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.
  • Key Competency Requirements

  • Has a thorough knowledge of ICH / GCP Guidelines and applicable local regulations.
  • 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.
  • Demonstrates a good understanding of Expected Areas of Competence as stated within this position profile and consistently demonstrates strong skills and behaviors.
  • Possesses strong knowledge typically attained through at least a Bachelor’s degree (or local equivalent) in a health related field and or developmental / clinical experience.
  • Independently makes decisions and takes action within the scope of Clinical Site Monitor responsibilities, based upon professional background and knowledge of study protocols, company procedures, ICH / GCP Guidelines and local regulations.
  • Knowledge of the integrated clinical development process through exposure to support of clinical projects. To be enhanced by attendance and occasional presentation at regular team meetings, internal / external training courses, workshop and seminars, where appropriate.
  • Completes assigned tasks / responsibilities on an increasingly independent and proactive scale.
  • Resolves study-related issues independently using functional expertise and exercises good judgment in escalating issues as necessary.
  • Opportunity to further develop skills in various technical applications.
  • Proposes innovative solutions to optimize processes, etc.
  • Provides role-related assistance to colleagues, as requested by peers or manager.
  • Expands medical / clinical expertise, learns new advances in drug therapies, as well as to gaining experience in multiple therapeutic areas.
  • Opportunity to enhance time management, prioritization and project management skills by supporting multiple GDO clients with competing timeline constraints.
  • Proposes innovative solutions to optimize processes, etc.
  • Opportunity to enhance teamwork skills by supporting information sharing & collaboration within the cross-functional environment.
  • Instinctively collaborates across organizational, functional and geographic boundaries to achieve departmental and company goals.
  • To build and expand on expected areas of competence as stated within this position profile.
  • Assists management in various administrative and management oriented tasks, as assigned or requested.
  • Ability to exhibit flexibility and being receptive to new systems and processes; and willing to enhance current skills to maximize proficiency.
  • Participates in departmental / divisional / role special projects, cross functional work groups, initiatives and task forces as opportunities arise.
  • Makes recommendations to management relative to department issues, policies, and procedures.
  • Takes appropriate and informed business risks.
  • Enhances communication skills with both internal (Global level) and all relevant external parties with coaching from manager (if required).
  • Demonstrates the ability to impact and influence others within a team to take action and contributes towards the establishment of best practices through coaching and feedback.
  • For SENIOR CLINICAL SITE MONITOR

  • Proactively identifies and resolves potential problems at both site and country / hub level, Engages with STM and / or line management to assist in the resolution of more complex issues.
  • Possesses substantial and in-depth knowledge typically attained through at least a Bachelor’s degree (or local equivalent) in a health related field and or developmental / clinical experience.
  • Proactively seeks to enhance communication skills with both internal (Global level) and all relevant external parties and coaches others to do the same.
  • Contributes significantly to study team and coaches site staff to enhance site and hub performance.
  • Independently makes decisions and takes action within the scope of Senior Clinical Site Monitor responsibilities and anticipates and proactively solves study site problems / issues as they occur.
  • Exhibits a high level of flexibility and sets an example for the department when leading and adapting to changes.
  • Serves 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.
  • Assists management in various tasks, as assigned or requested.
  • Proactively identifies and suggests innovative solutions to accomplish objectives while maximizing utilization of budget and resources.
  • Demonstrates strong leadership skills and role model behaviors.
  • Insight and working knowledge of other functional / cross functional roles via co-monitoring, job rotation, audit preparation and inspection readiness.
  • Enhances the opportunity for changing of career path.

  • Instinctively collaborates across organizational, functional and geographic boundaries to achieve departmental and company goals.
  • Takes appropriate and informed business risk and encourages others to do the same.
  • Works independently.
  • Leads or supervises departmental / divisional / role special projects, cross functional and geographic groups, task forces and study feasibilities as requested.
  • In addition to SME (or similar) role.

  • Makes innovative suggestions, as appropriate, to management for process or role change to enhance value of the position.
  • Travel Required

    Domestic & International travel where required

    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 the resources to pursue their goals, both at work and in their personal lives.

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