Senior Clinical Research Associate

cap N.A.TOPJOBS ' CLIENT

post time Posted 104 months ago

JOB PURPOSE/KEY RESPONSIBILITIES:

To plan, set up and monitor clinical studies, including regulatory, global (R&D), regional (Asia-Pacific R&D) and local trials, to support global and local clinical developments and to support marketing of COMPANY’s expansive portfolio of product(s) to the medical professional in Vietnam

Management of clinical trials :
In consultation with the Medical Advisor/Clinical Research Support or Medical Director
•    Contribute to the creation and progression of the clinical trial and establish detailed plans for each allocated study including the identification of investigators, study sites, protocol definition, record forms, timetable, study materials and budget
•    Set up, supervise and develop study centre staff to be compliant with Good Clinical Practice (GCP)
•    Coordinate and act as the primary contact person between investigators, company, regulatory authorities, and other COMPANY staff
•    Monitor the progress and standard of study conduct to assure adherence to the protocol, SOPs and GCP by visiting the investigator and their staff
•    Report the monitoring activities of the clinical study site visits/contacts according to the COMPANY SOPs.
•    Contribute to the clinical trial data to global/region/local R&D

Scientific Standard
Maintain state of the art knowledge of allocated products/disease areas.
Prepare and monitor clinical trial budget:
In consultation with MA/CRS or MD, negotiate Financial Agreement with Investigators to ensure cost-effectiveness as well as to ensure optimal funding from R&D to support core COMPANY Vietnam business and to plan annual clinical trials budget and to monitor this on a monthly or quarterly basis.

Clinical Research Team support, supervise, coach other less senior CRAs :
Do some training, supervise, coaching, co-monitoring , sharing best practice with other CRAs as necessary.
Good Clinical Practice and clinical compliance:
Ensure site staff are in compliance with GCP so that there are minimal findings by clinical auditors.

Network and develop relationships:
Both within COMPANY organisations and external parties e.g MoH, DAV, DST, and investigators, etc to establish successful working partnership which benefits COMPANY Vietnam business.
Commercial Support:
Keep abreast of advancement in core COMPANY therapeutic areas and key products to provide scientific objectivity and input to Commercial and Regulatory colleagues.

External Business Environment:
Monitor external environment and regularly inform Medical Director of key developments or regulations and provide strategic recommendations to ensure that COMPANY Vietnam are well prepared with appropriate responses. To actively influence external clinical research environment (MoH, DAV, DST, ADR center etc.) so as to provide business advantage to COMPANY Vietnam
Reports:
To regularly provide update/feedback on issues to the Medical Advisor/Clinical Research Support and to report monthly highlights (competitor intelligence, key issues which could impact business etc.) to Medical Director Collect information accurately and comprehensively to complete country feedback to study feasibility surveys

Other Assignments.
•    To be Clinical Trial Supplies Co-ordinator, doing clinical trial supply management in LOC
•    To be Local eTrack expert
•    To be the Back-up of the local Lead Named safety Contact (responsibility defined in local SOP no. VN-8104-02)
•    Others as assigned by Medical Director
JOB FACTORS

COMPETENCIES: (primary deliverables of competence)
LEADERSHIP COMPETENCY
•    Integrity
•    Innovation
PROFESSIONAL COMPETENCY
•    Interpersonal skill
•    Communication skill
•    Project Management skill
FUNCTIONAL COMPETENCY
•    English
•    Computer
•    Fast Learning skill

COMPLEXITY: (degree of change & uncertainty; level of influencing required; degree of matrix working)
1.    2.
SPECIALISED KNOWLEDGE: (breadth & depth across disciplines / functions; expertise in field required
Education:
•    Medical science background, Bachelor degree or higher preferable
Experiences:
•    Project planning. Medical knowledge (Medical / technical terms,etc.), Clinical trials working and/or monitoring experience.