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:

Participates in all data management activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout either as a study lead or backup data manager.  Manages the day-today data management project activities including, but not limited to, timelines, budgets, staff, project scope, reports and communication for the lifecycle of the project(s).  Mentors/trains Clinical Data Associates.

Primary Responsibilities:

• Perform study setup activities including CRF design, database structure design, annotation, document creation and/or approval, data entry screen design and testing, validation check testing and approval, etc.

• Allocate and prioritize workloads for multiple projects including listing reviews, external data reconciliation, and query management tasks

• Serve as a primary or backup resource for issues pertaining to data management

• Serve as an interim resource for issues pertaining to the study in the absence of the Project Clinical Data Manager

• Assist other Clinical Data Managers or Project Managers with management of timelines and budgets as they pertaining to data management activities

• Mentor all levels of Clinical Data Associates in their job responsibilities

• Maintain quality control of the data, project deliverables and closeouts

• Support and facilitate the review of medical coding for validity and completeness

• Adhere to all aspects of the SDC's quality system

• Comply with SDC's data integrity & business ethics requirements

• Perform other related duties incidental to the work described herein

• 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

• Competent working knowledge of clinical trials and the clinical data management role in the clinical trials process

• Excellent organizational and project management skills

• Able to lead teams to complete projects

• Highly effective communication skills, both written and verbal

• Technical skills including EDC systems, clinical data management systems, Microsoft Office

• Additional required skills include the following: CRF design, MS Project, and analytical capabilities.

• Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)

Education or Equivalent Experience

• Master's degree (preferably in engineering, applied or life science) and at least three (3) years of experience in clinical data management or

• Bachelor's degree and at least four (4) years of experience in clinical trials, or

• Current Certified Clinical Data Manager (CCDM) status and at least four (4) years in clinical trials.

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.

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