Principal Clinical Data Manager

Principal Clinical Data Manager

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.

Job Summary

The Principal Clinical Data Manager assists the Manager, 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.

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, delivery 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 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

Required Skills

• 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

• Typically a Master’s Degree (preferably in engineering, applied or life science) and five (5) years of experience in clinical data management, or

• Bachelor’s degree (preferably in engineering, applied or life science) and work experience and seven (7) years of experience in clinical data management, or

• Current Certified Clinical Data Manager (CCDM) status and seven (7) years of experience in clinical data management, or equivalent combination of experience, education, and/or demonstrated ability.

Benefits

Why SDC

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 value 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 and positive work/life balance, we are able to attract some of the most talented people in the industry.

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, 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 are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.

• With a proven track record, SDC has been successfully executing client clinical programs since 2005.

Take a look at how you can join our team!

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