Clinical Team Lead
Covance
Taipei City, Taiwan
3天前

Job Overview :

We are hiring Clinical Team Lead to insoruce to our client for project management and covers Taiwan, Hong Kong and China.

Responsibilites :

  • Collaborate, when applicable, with the Medical Advisors during the feasibility study process.
  • Ensure the fulfilment of objectives defined in the protocol (number of patients and centres, timelines, budget).
  • Ensure the ICH-GCP, corporate & local SOPs, and local regulations are respected and followed by all parties.
  • Prepare Clinical AED.
  • Participate in the submission of the project to the Ethics Committees and Health Authorities.
  • Validate the translation and adaptation of required documentation (protocol, informed consent form...), together with the Medical Advisors.
  • Actively ensure the obtaining of any study related documentation required for CTA application according to local regulation and Corporate & local SOPs, together with the Support Services Manager.
  • Finalize financial agreements (negotiation with the investigator, hospital, university, pharmacy, contractors, etc.).
  • Participate in the validation of Case report Forms (CRFs) when applicable
  • Select potential investigating centres according to their qualifications, clinical experience, research background and areas of expertise, in agreement with the Medical Advisors and Lead CPL.
  • Organize Local Investigator's Meetings and coordinate Investigator teams attendance to International Inv. Meetings.
  • Supervise, coordinate and lead CRA and CPA activities.
  • Identify any specific problem related to the study, and propose possible solutions in agreement with Lead CPL..
  • Ensure good site activation. In particular ensures that the Investigators are perfectly informed of the specific features of the study and its organization.
  • Monitor study progress : conduct co-monitoring when necessary, evaluate Monitoring Visit Reports, measure gap between planned and actual values (visits, monitored & compiled CRFs, DRFs), alert the project team, and make the necessary decisions and actions to solve any study related matter under his / her responsibility.
  • Supervise recruitment and motivate investigating centres (follow-up, newsletters, information on study progress, etc.).
  • Ensure that they have and maintain adequate equipment, materials and personnel to conduct the trial.

  • Conduct micro-planning follow-up in order to ensure that the committed targets (# active sites, # patients enrolled) are met in the committed administrative timelines, for the respective allocated clinical trials & Corporate Clinical Teams.
  • Monitor patient safety and drug tolerability by documenting adverse events, together with the GPE (Global Pharmacology and Epidemiology)
  • Control the quality of data collected, technical validation of CRFs.
  • Comply with the deadlines fixed by Data Management
  • Handle issues specifically related to the study : critical events, patient narratives, Clinical Study Report.
  • Administrative and Financial Management of the Clinical Trial.
  • Participate in the closing activities and organize archiving (together with local monitoring teams : CRAs / CPAs).
  • Participate in corporative and external Quality Audits and Inspections, coordinate the responses and ensure the follow-ups of corrective measures when necessary.
  • Ensure the good management of IP, together with the IP Manager.
  • Inform the CRU Director of the study progress and the difficulties encountered; reviews with him / her the strategy to implement.
  • Ensure that International Clinical Development (Clinical Investigations and Clinical Operations) have all necessary information on study progression.
  • Participate in study-related meetings organized by International Clinical Development.
  • Maintain professional expertise by attending lectures and conferences.
  • Contribute to information and training of local monitoring teams.
  • Education / Qualifications :

    Degree in medicine or Health sciences. Background in GCP& ICH, local & Corporate SOPs, and clinical research.

    Experience :

    More than 5 years of clinical research experience

    Preferred oncology experience

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