宜昌招聘

POSITION DESCRIPTION:

As a key member of Medtronic Clinical Operations (MCO) Data Management, this position is responsible for driving or leading all data management activities which assure quality of data delivery.

This position:

• is a key liaison with internal and external business partners including clincial study teams, clinical operations teams, Global IT, clinical IT developers, business strategists, data management support teams, statistical programmers, statisticians and / or vendors for the purpose of data management, system development, and data cleaning activities across multiple trials.

• Interacts with global team, and requires flexible attitude with regards to working hours (attending occasional Remote Meetings in evening hours)

• provides subject matter expertise for all data management related activities for the clinical teams and for more junior members of the Data Management organization.

• drives the development of data management tools, data quality, and data review activities.

• may lead and oversee data management processes for studies.

• may lead or work with additional project teams, disciplines, or functions within Medtronic.

• can act as a trainer, mentor, and Subject Matter Expert within data management

• Provides oversight and training for external vendors who are providing Data Management services

• Acts as a local representative for the Global Clincial Data Management organization in China

  POSITION RESPONSIBILITIES:

• Drives and leads all aspects of Data Management including:

• CRF specification and design and the specification of Edit Check requirements.

• assisting with the execution of validation and testing procedures of clinical database, eCRF and edit checks (eg, functional and user acceptance tests).

• ensuring the effective & efficient execution of data review and discrepancy management in accordance with the Data Management Plan and Data Review Guidelines.

• overseeing or mentoring data review requirements and processes to ensure delivery of highest quality of data.

• Ensures the timely and successful execution of data management objectives.

• Participating in/leading project meetings to ensure clear overview of progress, risks and mitigation strategies by all participants for all data management related deliverables. Ensures clear communication on project-status to sponsors or senior stakeholders.

• (C)FDA and Quality audits that involve data management.

• Creation and maintenance of all essential data mangement documentation including CRFs and annotated CRFs, Data Management Plans, Data Review Guidelines, CRF Completion Guidelines, Data Entry Guidelines, UAT Plans, and other study specific work instructions or guidelines for assigned projects to ensure compliance to quality system.

• Remaining current on data management technology, processes, and best practices via reading, presenting, giving trainings, membership in professional organizations, etc.

• Improving data management best practices/standards and Standard Operating Procedures compliance (eg, use of standardized Case Report Forms, univariate versus multivariate edit checks, reusable edit check specifications).

• Additional responsibilities including a focus on process improvement projects, enterprise wide initiatives, and program level data management.

• Identifying and monitoring key performance indicators. Driving continuous improvement and results via key performance metrics.

  ________________________________________________________________

  EXPECTATIONS

Role type Driving & Leading Level Senior Task complexity Objectives of medium complexity Level of guidance/oversight Low Scope of Data Management activities Near Full

________________________________________________________________

EDUCATION REQUIRED:

Bachelor’s degree (Masters preferred)

YEARS OF EXPERIENCE:

4-7 years experience in comparable role in a professional Clinical Data Management organization (2-5 years with Masters)

LANGUAGE SKILLS:

• Professional working proficiency in English language, both in writing as speech
• Professional working proficiency in Chinese language, both in writing as speech

SPECIALIZED KNOWLEDGE REQUIRED

• Clinical database systems knowledge: advanced level proficiency with relational databases (EDC) systems. Big-picture and detail-oriented view of data management processes, tools, and procedures.

________________________________________________________________

DESIRED/PREFERRED QUALIFICATIONS (optional)

(documented by either experience or certifications)

• Clinical Research Life Cycle process knowledge in medical device and/or pharmaceutical data management environment.
• Knowledge of clinical terminology, regulations, GCP, GDP, GDMP, FDA 21 CFR Part 11 regulation, ICH, and HIPAA.
• Intermediate to advanced skills and knowledge in adhoc data reporting, creating data review listings, and metrics reporting.
• Developing ability to contribute and/or interpret protocol to create CRFs and edit check specifications.
• Effective written, verbal, and interpersonal communication skills.
• Effective organizational skills and attention to detail.
• Ability to effectively manage and lead projects by applying project management methods and skills.
• Computer proficiency in MS Office products (eg, Microsoft Project, Excel, MS Word).
• Preferred experience in Oracle Clincial, CRF design tools, and reporting tools (eg, TOAD, Business Objects, Spotfire).
• Self motivated with strong sense of accountability.
• Excellent judgment, critical thinking, and problem solving.
• Team player who effectively works with colleagues and business partners;
• Experience with or knowledge of China FDA Order 25

• Clinical Trial Management System (CTMS) experience (preferably Siebel CTMS)

______________________________________________________________________

PHYSICAL JOB REQUIREMENTS: Physical capabilities to perform the job

• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.