Sunday, August 17, 2008

Singapore - Regional Clinical Operation Manager

Regional Clinical Operation Manager Responsibilities

Managing and coaching

Directs the Regional Project Managers (RPMs) in the preparation, conduct and close out of the trial
Make sure that Regional Project Managers understand requirements of SCOPE +- Monitoring Points, Roles, Processes and Responsibilities and prepare him/herself accordingly
Advise, coach and develop Regional Project Managers regarding the preparation of Master Plans, and regulatory documents including Clinical Trial Application process
Provide support to Regional Project Managers for Clinical Trial Supplies Unit (CTSU) and materials necessary for the trial
Participate in the improvement and maintenance of quality standards of ASIA, e.g. support of training function and working groups as appropriate
Provide training of RPMs /CMLs /CRAs of participating countries
Mediate and arrange training on trial specific standards, which support Regional Project Managers and the consistency in conduct clinical trials
Implement necessary specific processes and information systems for the conduct of the trial, e.g. CTMS including budgeting, electronic Clinical Trial Master File (e-CTMF), etc
Ensure adequate description of the planned clinical trial activities in CTMS for budgeting purposes
Support annual medical budgeting process
Provide clinical operational support to Regional Project Managers in order to resolve trial specific issues
Intervene in case of conflict/deviations/delays that cannot be resolved by Regional Project Managers
Resolve project related OPU specific conflicts through interaction with Regional Project Manager and RHCR
Ensure timely cleaning of data, DBL and delivery of results for Asia region
Recommend new Regional Project Managers in the clinical development project-related functions


Strategic development of New Compounds/ Therapeutic area in Asia

Disease Level

Develop knowledge of scientific developments for new therapeutic area in Asia region e.g. epidemiology such as prevalence or incidence, main causes of the disease, any possible differences between Asian and Caucasian, estimation of potential patients pool, current way of treatments, currently available drugs in the market, trend of new drug development for the disease, etc in each of Asian countries.
Mediate and arrange training on disease specific knowledge RPMs/CMLs/CRAs of Asian countries
Develop key potential investigators in connection with training
Develop and collect all necessary information for specific therapeutic area in Asia to collaborate with OPUs and Regional Preferred Provider
Collect and develop all potential investigators’ data base, patient pool, etc


Compound Level

Mediate and arrange training on compound specific training, which support RPMs, CMLs and also other medical staffs in the region and local OPUs
Take Asian medical strategic responsibility for clinical development of new compounds within Asia
Arrange and mediate TAH/TMM’s country visit and site visit for possible potential future trials in Asia
Mediate and prepare in advance for upcoming new studies throughout the feasibility in connection with TAH/TMM for the specific therapeutic area


Suitable applicants are invited to send in a detailed MS Word resume to hr3@magenta-consulting.com stating present/expected salaries and earliest available date.We thank all applicants in advance and regret that only short listed candidates will be notified.