Covance

Clinical Team Lead

Job Location(s) TW-Taipei City
Job Number
2020-44212
Job Category
Clinical Team Lead
Position Type
Full-Time

Job Overview

 
We are hiring Clinical Team Lead to insoruce to our client for project management.
 
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 1 year project management experience 
-More than 5 years of clinical research experience
-Preferred oncology experience

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