/ JOB DETAILS Date Posted: 04 Nov 2009
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Amgen (Asia) Limited  
Amgen is a leading human therapeutics company in the biotechnology industry. For more than 25 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. We are now seeking applications from suitably qualified person for the following position;

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Clinical Operations Manager

The Role

Located in Amgen Asia regional office in Hong Kong

Overseeing the regional execution of clinical trials for multiple products

Independently managing clinical trials in mainland China

Mentoring/training staff in HK and China

Interacting with internal stakeholders or external business partner, like CROs

Key Responsibilities

Leading local clinical program and developing country/regional study strategies

Delivering local study recruitment and timeline commitments

Management of clinical studies through their life cycles (from feasibility to study completion ) 

Developing and maintaining the relationship with country/regional investigators

Providing  product-specific training & staff training

Providing  study status reports and progress updates to management

Qualifications

MD, Pharm D, MPH, MS or BA/BS in science with extensive pharm industry experience, previous medical training is preferred

Knowledge of therapeutic areas, cardiology, oncology and anti-inflammation is desirable

Extensive knowledge of ICH/GCP guidelines in Asian countries, regulatory and drug safety experiences is a plus       

Ability to work effectively in matrix environment

Strong project management & planning skills                       

Ability to identify operational issues, and provide timely resolution

Proficient with computer software

Excellent written and oral communication skills in English and Chinese (Mandarin language skill is required)

Flexibility in working and ability to travel

Excellent interpersonal skills with leadership quality

Experience

4 to 6 years experience in clinical development in industry setting (clinical trial specialist, clinical project manager or equivalent) in Asian countries

Minimum 2 years direct management experiences in multinational clinical research

Track record & 1st hand experience of clinical trial management in mainland China

Interested party, please forward your CV to amgenasia@amgen.com .  We regret that only shortlisted candidates will be invited for interview.

 
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