Clinical Data Manager, Scottsdale, AZ

Clinical Data Manager (CDM), Scottsdale, AZ

Position Summary:  The Data Manager's primary responsibilities are to lead, direct, and conduct all the CDM activities and accountabilities for each assigned clinical study. Other duties may include: coordinating with the appropriate staff to complete work as detailed in a client's work order, oversight of filing project related documents, effectively communicating project status with internal and external stakeholders, and partnering with Compliance, IT, and CDM for validation or qualification of data collection tools or spreadsheets. 
 
The Data Manager will assist the Director Data Management in coordinating and executing the diverse tasks involved in assisting clients' and Data Management activities. 

Job Duties and Responsibilities:

  • Serve as primary clinical data management contact for internal team and external customers 
  • Lead DM aspects of processing radiological images received for client projects in accordance with standard operating procedures 
  • Create and maintain Data Management Plans 
  • Lead design and development of CRFs and eCRFs; oversee vendor CRF development 
  • Lead design and development of EDC and other databases; oversee vendor EDC database development 
  • Oversee entry of clinical trial data into data collection tools 
  • Oversee conduct of quality control review of clinical trial data 
  • Conduct data review of CRFs, eCRFs, reports, or data listings, as applicable 
  • Generate, track, and close queries for images, reports, CRFs, eCRFs, as applicable 
  • Lead creation and maintenance of data transfer specifications 
  • Conduct data / image transfers, as applicable 
  • Monitor radiology readers for applicable on-site reads 
  • Track conduct of DE/QC activities 
  • Oversee generation and/or quality control review of Diagnostic and Summary Reports 
  • Lead applicable data analysis activities 
  • Lead database lock activities 
  • Lead study closeout and reconciliation activities 
  • Lead UAT activities for data collection and transfer systems/tools, including creating UAT Plan and Test Cases 
  • Maintain both paper and electronic project files in accordance with standard operating procedures 
  • Advocate compliance with all standard operating procedures 
  • Create applicable Study Specific Procedures (SSPs) 
  • Create applicable study specific reports 
  • Assist with development and versioning of CDM department SOPs 
  • Lead generation of study specific data collection tools/databases 
  • Assist with training and monitoring of Clinical Data Assistants and Clinical Data Coordinators 
  • Update appropriate study team members and management with task, deliverable, and project statuses.  Coordinate efforts to ensure on time completion of high quality deliverables to both internal and external partners and customers 
  • Perform other tasks as needed 

Job Requirements:

  • Expertise in using MS Office and internet applications required 
  • Bachelor's Degree (BS) required or equivalent combination of education and relevant work experience 
  • Clinical data management experience required 
  • Electronic Data Capture experience required (i.e. Medidata RAVE, InForm, Medrio) 
  • Working knowledge of medical terminology required 
  • Knowledge of clinical trials and/or healthcare industries required 
  • Must have great attention to detail and excellent oral and written communication skills 
  • Ability to excel in a team environment 
  • Must have the ability to multitask and work under pressure 
  • Must have strong time management and organizational skills. Prioritizing workload to the changing needs of the day to day business is a critical skill. 
  • Able to quickly and accurately assess the importance of a phone call, email, or document and take appropriate action to involve the appropriate parties 
  • Work precisely according to all procedures, rules and regulations 
  • Must maintain strict confidentiality of sensitive data, records, files, conversations, etc. 
  • Self-motivated and able to grasp new concepts quickly 

Physical Requirements:
While performing the duties of this position, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit.  Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.  

APPLY TODAY!  Questions?  Call Kevin at 602-548-1774 or email at Kevin.Lau@kellyscientific.com 

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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