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Sr. Manager, Clinical Data Management
Statistics & Data Corporation (SDC) Waltham, MA

Sr. Manager, Clinical Data Management

Statistics & Data Corporation (SDC)
Waltham, MA
Expired: June 06, 2023 Applications are no longer accepted.
  • Full-Time
Job Description
Company Info

Oversees and manages all aspects of data management operations including staffing and resourcing, project management, operations management and client management. Applies a high level of technical expertise to effectively lead all data management.

Primary Responsibilities

  • Oversee day-to-day data management operations
  • Serve as subject matter expert during client and vendor meetings
  • Actively support business development in capabilities presentations to prospective and current clients
  • Effectively provides input for department and clinical study budgets
  • Liaise with internal and external cross-functional teams, sponsors, vendors, etc. •Serve as project manager on clinical studies, as needed
  • Work closely with Director of Data Management, Managers of Data Management, Clinical Data Managers and Clinical Data Analyst to mentor data management staff
  • Ensure project work is planned, resource allocated and is successfully executed
  • Provide direction to staff when issues arise that the staff cannot resolve on their own
  • Ensure proper training and development of staff
  • Conduct regular meetings and completes year-end performance reviews with all direct reports
  • Monitor performance of team and initiate process and resource improvement in partnership with Director of Data Management

Requirements
  • Articulate and professional •Extensive experience in Clinical research
  • Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
  • Strong project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating, and resource management skills
  • Effective leadership, budget forecast, and implementation skills
  • EDC experience in multiple EDC systems including Medidata Rave preferred •May Require Travel up to 20%
  • Four (4) years of experience direct management of personnel is required
  • Clinical Research experience in a CRO setting preferred; CDISC SDTM training and experience are preferred.

Education or Equivalent Experience
  • Master's degree (preferably in engineering, applied or life science) and at least seven (7) years of experience in clinical data management including leading several clinical studies

OR
  • Bachelor's degree (preferably in engineering, applied or life science) or equivalent education and work experience with a minimum of eight (8) years of experience in clinical trials, or current Certified Clinical Data Manager (CCDM) status and nine (9) years of experience in a clinical trial.

Benefits

What you can expect from us:
  • We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, and offer a flexible work schedule, engaging work culture, and employee benefits.
  • We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
  • We strive to provide a place of belonging to our employees with fun and engaging activities from SDC's culture club.
  • We constantly grow and innovate to support our clients and employees' needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
  • With a proven track record, SDC has successfully executed client clinical programs since 2005.
  • Health Care Plan (Medical, Dental & Vision)
  • Retirement Plan (401k)
  • Life Insurance (Basic, Voluntary & AD&D)
  • Paid Time Off (Vacation, Sick & Public Holidays)
  • Family Leave (Maternity, Paternity)
  • Short-Term & Long-Term Disability
  • Training & Development
  • Work From Home
  • Profit based incentive

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