Associate Site Manager, GCTO
MSD
Guangzhou, 44, CN
22天前

Description of Roles and Responsibilities

Acts as primary site contact and site manager throughout all

phases of a clinical research study, taking overall responsibility of

allocated sites.

  • Develops strong site relationships and ensures
  • continuity of site relationships through all phases of the trial.

  • Performs clinical study site
  • management / monitoring activities in compliance with ICH-GCP, Sponsor SOPs,

    Local Laws & Regulations, Protocol, Site Monitoring Plan and associated

    documents.

  • Gains an in-depth understanding of the study
  • protocol and related procedures.

  • Coordinates & manages various tasks in
  • collaboration with other sponsor roles to achieve Site Ready.

  • Participates & provides inputs on site
  • selection and validation activities.

  • Performs remote and on-site monitoring &
  • oversight activities using various tools to ensure :

  • Data generated at site are
  • complete, accurate and unbiased

  • Subjects’ right, safety and
  • well-being are protected

  • Conducts site visits including but not limited
  • to validation visits, initiation visits, monitoring visits, close-out visits

    and records clear, comprehensive and accurate visit & non-visit contact

    reports appropriately in a timely manner.

  • Collects, reviews, and monitors required
  • regulatory documentation for study start-up, study maintenance and study

    close-out.

  • Communicates with Investigators and site staff
  • on issues related to protocol conduct, recruitment, retention, protocol

    deviations, regulatory documentation, site audits / inspections and overall

    site performance.

  • Identifies, assesses and resolves site
  • performance, quality or compliance problems and escalates per defined CRA

    Escalation Pathway as appropriate in collaboration with CRM, PLM and RCPM.

  • Manages and maintains information and
  • documentation in CTMS, eTMF and various other systems as appropriate and per

    timelines.

  • Contributes strongly to CRA team knowledge by
  • acting as process Subject Matter Expert (SME), sharing best practices, making

    recommendations for continuous improvement and providing training as

    appropriate / required.

  • Supports and / or leads audit / inspection
  • activities as needed.

  • Mentors / buddies junior CRAs on process / study
  • requirements and performs co-monitoring visits where appropriate

    Requirements :
  • Expeirence
  • Expeirence
  • Min. 4 years of direct site management (monitoring) experience in a bio / pharma. / CRO.
  • Education
  • B.A. / B.S. preferred with strong emphasis in science and / or biology
  • Travel
  • Ability to travel domestically and internationally approximately 65%-75% of working time.
  • Core Competency
  • Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
  • Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP / ICH & country clinical research law & guidelines.
  • Excellent understanding of Global, Country / Regional Clinical Research Guidelines and ability to work within these guidelines.
  • Demonstrated ability to mentor / lead
  • Hands on knowledge of Good Documentation Practices
  • Proven Skills in Site Management including independent management of site performance and patient recruitment
  • Demonstrated high level of monitoring skill with independent professional judgment.
  • Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
  • Behavioral Competency
  • Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
  • Able to work highly independently across multiple protocols, sites and therapy areas.
  • High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
  • Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
  • Demonstrates commitment to Customer focus.
  • Works with high quality and compliance mindset
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