Clinical Affair Manager
Location: Beijing, Beijing Shi CN
Job Number: 957
Job Title: Clinical Affair Manager
Reporting Line: Sr. Medical & Regulatory Affairs Manager, APAC.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments.
There’s never been a more exciting time to join us.
Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful.
Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.
We are headquartered in Massachusetts and have centers of operation across North America, Europe, Central America, Australia and Asia. We have the strength and resources of a billion dollar company and the vision of leaders committed to a broad spectrum of health issues.
We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future. There has never been a more exciting time in our company’s history. Visit our website to learn more about the many career opportunities we have available today.
Hologic has China commercial organization with headquarter in Beijing. We aim to build the China Organization into an exciting place to work and grow professionally.
SUMMARY OF DUTIES AND RESPONSIBILITIES
• Take charge of the management and operation of clinical trial projects, coordinate cross-functional team(s) in the execution of clinical trials
• Manage the planning and execution of clinical studies, including data collection activities; set up Clinical Trail strategy and overall control Clinical Trail timeline; build SOPs related with Clinical Trail
• Establish project plan with clear timeline and deliverables and ensure the implementation of the defined plan
• Responsible for CROs selection as needed
• Play a leading role in the qualification of clinical trial sites to be responsible for site selection, site qualification, site monitoring, site management, if necessary negotiate site contracts
• Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion
• Establish scientific methods for design and implementation of study protocols and data collection systems that meet quality and regulatory requirements
• Lead reviews of data periodically, analyst and interpret clinical trial data, prepare clinical study final reports & close the trial
• Interact with various internal/external groups to facilitate completion of studies for inclusion in regulatory submissions for devices
• Conform to applicable regulations and standards and company quality policies, ensure that all aspects of GCP for Medical Device are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Good knowledge of clinical trial process and the process of sites
• Able to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
• Can exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
• Knows how to go through the proper channels to get things done
• Sets specific goals and objectives, ability to plan for the length and difficulty of assignments, ability to break down projects into specific tasks/steps
• Ability to simplify complex processes and to organize people and activities
• Excellent interpersonal skills with proven ability to work both in a team-oriented environment and independently
• Experience working independently in a fast-paced environment with rapidly changing priorities
• Chinese native speaker with fluent English in both written and spoken
• MSc in a scientific field (biology, clinical, pharmacy), Medical background preferred
• Around 7 years’ clinical research experiences in relevant industry
• Experience in a GMP and/or FDA regulated environment with detailed knowledge of GCP for Medical Device including basic understanding of regulatory requirements, Chinese regulation preferred
• Experience in CER preparation is preferred
Job Number: 957
Community / Marketing Title: Clinical Affair Manager
Location_formattedLocationLong: Beijing, Beijing Shi CN