Manager Data Management

eClinical Solutions

Mansfield, MA, US
  • Job Type: Full-Time
  • Function: Data Science
  • Post Date: 04/23/2021
  • Website: eclinicalsol.com
  • Company Address: 603 West Street , Mansfield, MA, 02048

About eClinical Solutions

eClinical Solutions seamlessly orchestrates clinical technology and expertise to help accelerate the clinical development process.

Job Description

eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate®, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate®  - enabling our life sciences clients to proactively manage their clinical programs and make decisions.

 

 The Manager, Data Management is operationally responsible to provide leadership for end-to-end delivery of data management services for assigned projects/studies, collaborating with Clients and other vendors to ensure high quality deliverables are on time and within budget. The Manager, Data Management partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.  The Manager, Data Management possesses a working knowledge of clinical operations and relevant regulatory requirements. 

 

 KEY TASKS & RESPONSIBILITIES

 

  • Manage the data management delivery team and develop the capability for the group to support the existing workload while building expanding the capability as necessary to support the growth of the organization
  • Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable eClinical Solutions and regulatory requirements
  • Provide project and strategic consulting and management activities while delivering the highest degree of quality, optimizing efficiencies and ensuring consistency and repeatability
  • Develop, implement and execute data management strategies to allow Clients to better leverage their clinical data
  • Develop a mindset throughout the organization that will foster intimate customer relationships resulting in account growth and repeat business
  • Mentor and assist with the growth of all data management employees by recruiting, developing, and retaining “A players”
  • Regularly present updates on the status of the Data Management team to the eClinical Leadership Team and others, as required
  • Contribute to and monitor eClinical Solutions division and project financials with a focus on annual budgets versus actual revenue, gross margin and net profit targets   
  • Interact with multiple vendors including clinical CROs, lab vendors, IVRS etc. on assigned projects to ensure data needs are met
  • Ensure compliance with eClinical and industry quality standards, guidelines and procedures
  • Proactively address any/all issues as and when appropriate
  • Identify and promote appropriate training and development programs for staff
  • Provides comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes
  • Serve as Project Level Data Manager as required

 

CANDIDATE’S PROFILE

 

Education/Language

 

  • Basic Science/Bachelor of Science degree (Master’s in Science preferred) in health-related field
  • Excellent command of the English language (both written and verbal) 

 

Professional Skills & Experience

 

  • 10 years working in the Life Sciences industry, preferably with significant experience supporting Pharmaceutical/Biotechnology/Medical Device organizations in a consultative role
  • Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
  • Demonstrated experience managing complex client relationships requiring multiple DM services and projects
  • Strong data management and EDC experience required
  • Excellent verbal and written communication skills
  • Proven ability to motivate and mentor data management staff resulting in a world-class delivery team
  • A detail-oriented team player with strong organizational skills and the ability to multi-task, prioritize and plan within a high-energy, solutions-based environment where the customer comes first.

 

Technical Skills & Experience

 

  • Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
  • Strong familiarity with EDC and Clinical Data Management Systems: Medidata Rave is preferred

 

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based qualifications, merit, culture fit and business need.



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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.