Clinical Data Manager II - Regional

PPD   •  

Austin, TX

Industry: Biotech/Pharma


Less than 5 years

Posted 300 days ago

This job is no longer available.


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 Education and Experience:

  • Bachelor's degree or equivalency in education (e.g., R.N., M.T., P.A., R.Ph, etc.) and experience demonstrating theoretical knowledge of biology, chemistry, physics, and/or health sciences, or closely related
  • 3+ years of data management experience
  • Or a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily

Knowledge, Skills and Abilities:

  • Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, Standard Operating Procedures and client expectations
  • Strong attention to detail and skill with numbers
  • Ability to use interactive computer programs
  • Good written and verbal communication skills
  • Good organizational skills
  • Good analytical/problem-solving skills
  • Ability to work productively with minimal supervision
  • Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
  • Ability to attain, maintain and apply a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
  • Strong customer focus and excellent interpersonal skills
  • Proven flexibility and adaptability
  • Ability to work in a team environment and independently as needed
  • Ability to act as a study or department expert for DM processes
  • Ability to assist in forecasting project resourcing and hours needed
  • Ability to train and direct study team
  • Must demonstrate good judgment in making decisions
  • Ability to travel to other locations as required or as business need dictates
  • Must be able to set and meet timelines or be able to recognize and schedule changes in response to project demands
  • Ability to identify potential out of scope activities to project and CDM management and to assist with the contractmodification process
  • Strong command of English language and grammar

Working Conditions:

  • Work is performed in an office/ laboratory and/or a clinical environment.
  • Exposure to biological fluids with potential exposure to infectious organisms. 
  • Exposure to electrical office equipment. 
  • Personal protective equipment required such as protective eyewear, garments and gloves. 

Physical Requirements:

  • Ability to work in an upright and /or stationary position for 6-8 hours per day.   
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.  
  • Frequent mobility required.
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.    
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Frequently interacts with others to obtain or relate information to diverse groups.   
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.  Ability to perform under stress.  Ability to multi-task.  
  • Regular and consistent attendance.