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Clinical Research Associate, APAC Job

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Date: Feb 22, 2021

Location: Hong Kong, HK, HK

Company: Boston Scientific

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

 

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

Role Purpose

 

Monitors progress of clinical studies at the site level to verify that the rights and well being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocal, standard operating procedures, ISO/GCP and other applicable regulatory requirements. Provides support in start up, enrollment, follow up and closure of clinical trial activities conducted in APAC region. This role will be based in Hong Kong.

 

Role Responsibilities

 

  • Collaborates with project team in the planning and execution of all operational aspects of clinical trials (Pre-Market, PMS studies and Investigator Initiated studies).
  • Leads and executes clinical studies in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures through successful collaboration with key opinion leaders across therapies and approved CRO partners.
  • Provides trial operation, site management, ethics and regulatory authority level coordination of assigned clinical studies and at the site level to verify that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements.
  • Source Verification: conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Conset Forms for accuracy and completeness, reviews regulatory documents and device accountability records. Issue, investigate and resolve data discrepancies.
  • Communications: ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence.
  • Training: ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitor and maintain site personnel list, qualification and training records.
  • Site Compliance: ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. Support regulatory inspection activities as required.
  • Event Reporting: ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
  • Collaoration: participates in study-specific meetings, teleconferences and trainings. Collaborates with cross-functional team members and study sites throughout all study phases.
  • Documentation: Manages study contracts, request/collection of relevant documention, review and apprvoal of subset of documents in applicable database.

 

Role Requirements

  • Possess a degree in Medicine, Pharmacy or Science. Post Graduate degree will be a plus.
  • At least 3-4 years of progressive experience in conducting clinical studies in Asia Pacific region. This includes minimum of 2-3 years of experience in Medical Device industry.
  • Clinical study experience in Cardiovascular, Peripheral Interventions & Rhythm Management specialty areas would be an added advantage.
  • Ability to apply comprehensive technical knowledge of a field to resolve complex issues in creative ways.
  • Has a proven track record of managing multiple tasks within a matrix working environment.
  • Strong process, project and time management skills with the ability to organize and handle multiple priorities.
  • Demonstrated ability to positively influence key stakeholders without direct authority.
  • Culturally sensitive with excellent communication skills
  • Fluency in spoken and written English is required; other language skills will be a plus.
  • Proactive, enjoys working in a challenging environment, results-oriented and a team player.

 

 

About us

 

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Boston Scientific is proud to be recognized for our innovations that impact patients' lives, our performance as a company, our workplace culture and our contributions to communities around the world. Some of our recent accolades include:

  • Forbes Most Innovative Companies (2018)
  • Forbes list of World's Best Employers (2018)
  • FORTUNE World’s Most Admired Companies (2018, 2017, 2016)
  • Glassdoor’s Highest Rated CEOs (2018, 2017)

 

For more information, please visit us at

Visit www.bostonscientific.com to learn more and apply


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