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Associate Director, Clinical Data Management Systems Integration (SC5328)

Palo Alto, CA · Biotech/Pharmaceutical
Job Title:  Associate Director, Clinical Data Management Systems Integration (SC5328)
Location: Palo Alto, CA. 94304
Employment Type:  Permanent
Business Unit: Clinical Data Innovation
Duration: N/A
Posting Date: 10/23/20
 
 
3 Key Consulting is recruiting an Associate Director, Clinical Data Management Systems Integration for a permanent position with our direct client, a leading international biopharmaceutical company.
 
Job Description:
Our client is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. They are continuing to expand their commercial product portfolio and their research and development pipeline in therapeutic areas that can leverage their unique expertise.
 
Their therapeutic areas of focus include sleep and hematology/oncology – areas in which they have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join their team.  
 
The Associate Director of CDM Systems Integration will be the CDM lead for all client Clinical Data Factory (CDF) activities as well as future system selection and onboarding. In this position, the person will work closely with R&D team members within CDM, Clinical Operations, R&D IT Analytics, Clinical Development and Biometrics to develop, implement, standardize, and maintain solutions for the operationalization of clinical trials.  This individual may lead 1-2 direct reports. The Associate Director of CDM Systems Integration will report into the Director of Clinical Data Innovation.  Essential functions include:
  • Manage client CDF and other information systems within CDM and provide architectural, technical, and strategic inputs to multiple projects.
  • Collaborate with technology teams, System Owners (SO), Business Process Owners (BPO), business end users, and functional leaders to manage implementation of clinical studies within the client CDF and other platforms, training requirements and training content.
  • Lead, manage, develop, coach and support individuals responsible for training options, user access and technical support in relation to the client CDF and other CDM information systems.
  • Work with the BPOs and SOs to resolve complex operational problems provide solutions to facilitate the comprehensive adoption and effectiveness of the client CDF
  • Cultivate and disseminate knowledge of application-usage best practices.
  • Determine business needs across the R&D group and translate this into system and end user requirements.
  • Work with the BPOs and SOs to solve complex problems and analyze potential solutions to ensure GxP compliance and determine and document future needs.
  • Create and review technology requests for proposals (RFP) and engage in the vendor selection process
  • Coordinate with external vendors (in particular eClinical Solutions), SOs and BPOs to manage or support the development of the client CDF and other platforms, including software updates and patch fixes.
  • Plan, prepare, and implement validation testing processes to ensure that deliverables adhere to system user requirements and GxP requirements.
  • Maintain CDM’s repository of software applications and their integrations through best practices and the appropriate staffing and management of a technical team to support this effort.
  • Develop and/or implement change management strategies to enhance system adoption across the R&D function.
  • Perform/assess time and resource estimates for project planning, managing timelines for studies/projects.
 
Basic Qualifications:
  • Thorough knowledge of clinical trial study design, data collection and the drug development process.
  • Ability to manage multiple complex projects and assess resource needs.
  • Excellent verbal and written communication skills.
  • Background in designing visualization tools in a clinical trial data visualization environment.
  • Experience with CDASH standards.
  • Familiarity with clinical data sets from major EDC systems (e.g., Medidata Rave, InForm, TrialMaster), safety systems (Argus), and CTMS systems.
  • Understanding of clinical data structures, relational database structures, and data exchange.
  • In depth understanding of regulatory, industry (GCP), and technology standards and requirements [ICH E6 and Regulatory Guidelines and SDLC].
  • Strong project management skills and ability to work in a cross-functional team environment.
  • Knowledge of ICH E6 (R2) Risk Based Monitoring a plus.
  • Experience with SAS, T-SQL, and Qlik is a plus.
  • Bachelor or Master's Degree in Biology, Mathematics, or related fields required
  • 10 years in a clinical trial role including 3 years minimum of line management and leadership responsibilities preferred.
 
Preferred Skills:
Knowledge of ICH E6 (R2) Risk Based Monitoring a plus Experience with SAS, T-SQL, and Qlik is a plus.
 
Must Have Skill Set:
  • Must be able to work on site when our offices reopen.
  • Bachelor or Master's Degree in Biology, Mathematics, or related fields.
  • Thorough knowledge of clinical trial study design, data collection and the drug development process.
  • Ability to manage multiple complex projects and assess resource needs.
  • Excellent verbal and written communication skills Background in designing visualization tools in a clinical trial data visualization environment.
  • Experience with CDASH standards Familiarity with clinical data sets from major EDC systems (e.g., Medidata Rave, InForm, TrialMaster), safety systems (Argus), and CTMS systems.
 
Employee Value Proposition:
Our client was literally created to be a great place to work. Their culture is inclusive and dynamic and had two successful launches during the Pandemic and they are one of a few companies that continue to grow during COVID.
  • Competitive salary and benefits.
  • Relocation package.
  • Target bonus.
  • Sponsorship.
  • Equity.
 
Interview process:
Video Skype Panel Interview:
 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 

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