Senior Clinical Research Associate
Asia Leap Pte Ltd
Company Description
We are an executive search firm serving organisations across Asia. We provide career advice and dedicated professional assistance in facilitating your career advancements for the long term.
We are currently seeking qualified candidates to fill the role of Senior Clinical Research Associate for a multinational.
Responsibilities:
* Oversee local clinical programs in terms of monitoring investigator sites for GCP compliance (this includes pre-study, initiation, routine and close-out visits)
* Assign sites to CRA and conduct training sessions
* Review site issues listings, deviation reports and develop protocols and CRFs
* Prepare and review clinical study reports, clinical data analysis, SOPs and GCP compliance
* Verify that CRAs have resolved all data management queries, completed CRF review, retrieved CRFs and transmitted to appropriate location
* Displays insight in analyzing complex situations, considers various approaches and perspectives in addressing problems, and makes timely decisions, anticipating their potential impact and using sound judgment
* Serve as central point of contact between sponsor and project manager, CRAs and applicable supporting staff
* Understands and interprets technical, scientific and clinical information and applies that understanding to clinical trial activities
* Meet project cost, schedule, and performance requirements.
Requirements:
* Minimum degree in life science or healthcare related field.
* At least 3 - 5years of clinical trials experience in the biopharmaceutical industry including 2 years in clinical study site monitoring.
* Ability to train and mentor Junior CRAs/CTCs/CTAs
* Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations and also excellent working knowledge of concepts of clinical research and drug development
* Able to work independently and under pressure to deliver high quality work on time.
* Demonstrate strengths in planning, organizational, project management and analytical skills.
We invite applicants to submit their CVs to recruit@asia-leap.com
This job was posted 30+ days ago, and has expired.
