长沙招聘

The CDx Study Manager position requires the ability to work in a global virtual team on the tasks relative to the development and management of Companion Diagnostic trials.
This position will serve as a liaison on a global basis between internal Covance Departments and Diagnostic and Pharmaceutical companies regarding Companion Diagnostics study to ensure successful management and delivery of testing results.
CDx Study Manager must show flexibility when appropriate and possesses
capability to make decisions, must be able to act as consultant or technical expert relative to allocated portfolio of studies and to demonstrate integrity, dedication and ability to deliver outstanding customer service.


Responsibilities/Duties Day to Day Study Management:

1. Participate in protocol review and study feasibility. Act as a consultant in providing recommendations and advice to all applicable parties
2. Ability to create and motivate a team around project deliverables
3. Provide day-to-day project management oversight; effectively managing, planning and coordinating all project related activities
4. Demonstrate through appropriate self organization the ability to manage conflicting priorities and to make difficult decisions
5. Able to act efficiently in an environment with dynamic timelines and priorities
6. Work with appropriate internal and external personnel to understand the culture and pipeline of assigned clients
7. Demonstrate strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time and within budget
8. Participate in Covance CLS development through continuous process improvement, quality and productivity
9. Regulatory/ Study Documentation
10.Maintain all necessary study documentation, including but not limited to: study binders, material receipt forms, and material balance forms.
11. Report Adverse Events as needed.
12. Report protocol deviations as needed.

Internal Liaison
1. Acts as an ambassador on behalf of the client within Covance CLS and across Covance business units; exemplifies the concept of Signature Client Service through outstanding, personalized customer service skills.
2. Demonstrate a sound working knowledge of internal function and units and Covance business acumen.
3. With project team members (PM, TA), develop solutions, resolve issues and approve internal database loading/design plan.
4. Serve as an accountable resource upon solicitation by team members.
5. Upon consultation and approval with applicable laboratory department management, customize workflow for projects as needed.
6. Communicate with Data Managers to assist with resolving data transmission issues; perform data revisions as needed.
7. Serve as facilitator and organizer of internal project meetings and technical discussions.
8. Coordinate with IT, Lab Compliance, Lab Technology, and/or Quality Assurance on new project start-ups, new instrumentation start-ups, or instrumentation middleware as needed.
9. Interact with WLOS regarding testing selection of test codes (including use or need of new test codes), reflexes, calculations, administrative questions (AD), procedures, and Antrim, Envision, and/or Zavacor issues.

Essential External Client-related Job Duties
1. Ensures that all customer expectations are documented and acted upon in compliance with regulatory requirements
2. Host and participate directly in audits or monitoring visits related to Companion Diagnostic studies.
3. Act as primary point of contact and liaison for Diagnostic Clients; liaise with CLS Project Management with external Pharmaceutical Clients.


Requirements

1. BS degree in Biology, Chemistry or other Life Science or Medical Technology degree.
2. Or Prefer professional certification (ASCP, PMP or other) in area(s) of expertise.
3. or Computer literate.
4. Prefer 5 years of clinical laboratory experience. Experience with multidisciplinary lab background is a plus. Project Management experience is a plus

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/