Principal Clinical Data Manager

Raleigh, North Carolina, United States - Remote

Statistics & Data Corporation (SDC)

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SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high-quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a valued partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances, positive work/life balance, and 401k matching (US), we are able to attract some of the most talented people in the industry.

This person will assists the Manager of Data Management in the oversight and execution of Data Management operations. Provides oversight for all data management operational activities in support of both clinical and non-clinical research studies from study build through study close. Mentors and trains Clinical Data Management staff.

***Candidates must reside in Arizona or along the east costal line in US***

Recruiting agencies, please do not submit unsolicited referrals for this or any open role. We have established agency partnerships, and we will not pay any fee associated with unsolicited referrals.

#LI-Remote

Primary Responsibilities

  • Effectively plan and execute multiple Data Management projects simultaneously. Provide updates directly to senior stakeholders as requested by management.
  • Serve as a subject matter expert
  • Participate in Business Development presentations and bid development
  • Assigns tasks and responsibilities within Data Management to team members that optimizes team capacity, delivers of timely & accurate results, and supports the needs of the business.
  • Provide mentoring and coaching to data management staff in daily operational activities
  • Communicate with cross-functional groups and stakeholders throughout the project lifecycle
  • Manage sponsor relationships and triage issues as appropriate
  • Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections
  • Maintain Quality control of the clinical data, project deliverables, and closeouts
  • Adhere to all aspects of SDC’s quality system
  • Comply with SDC’s data integrity and business ethics requirements
  • Perform other duties as assigned
  • Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.


Requirements

  • Exceptional working knowledge of clinical trials and the data management role
  • Excellent organizational and project management skills
  • Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
  • Technical skills with EDC systems, CDMS and other relational databases, and Microsoft Office products
  • Able to work independently and in teams
  • Project management abilities including analytical evaluation, organization, flexible team management, negotiating and resource management skills
  • Excellent organizational and time management skills, with the ability to multi-task
  • Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
  • Strong interpersonal communication and presentation skills
  • Able to effectively collaborate across cross-functional teams

Education or Equivalent Experience

  • Master’s Degree (preferably in engineering, applied or life science) and at least five (6) years of experience in clinical data management, or
  • Bachelor’s degree (preferably in engineering, applied or life science) and work experience and at least seven
  • Current Certified Clinical Data Manager (CCDM) status and at least seven (7) years of experience in clinical data management.
  • (7) years of experience in clinical data management, or

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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* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰

Tags: Classification Consulting Data management Engineering GCP RDBMS Research

Perks/benefits: 401(k) matching Career development Competitive pay Flex hours Flex vacation Health care Insurance Medical leave Parental leave Startup environment

Regions: Remote/Anywhere North America
Country: United States
Job stats:  4  0  0
Category: Leadership Jobs

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