Job Description

Clinical Data Manager

Statistics & Data Corporation (SDC), A global contract research organization (CRO) headquartered in Arizona, providing clinical trial solutions for pharmaceutical, biologic, and medical device/diagnostic companies since 2005. Our core expertise is strategic scientific consulting and clinical data services which include biostatistics, data management/EDC, and IRT/IWRS.

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 working closely with the lead Clinical Data Manager(s) and/or Clinical Data Analyst(s). Manages the day-to-day data management project activities including, but not limited to, study start-up, conduct, timelines, metrics, reports and communication for the lifecycle of the project(s).

Primary Responsibilities

• Independently perform study setup activities including CRF design, database structure design, annotation, DMP, CRF completion guidelines, Data Validation Manual (DVM) creation and/or approval, data entry screen design and testing, validation check testing and approval, etc.
• Serve as a primary or backup resource for issues pertaining to data management
• Assist other Clinical Data Managers or Project Managers with management of timelines and communication as they pertain to data management activities
• Work closely with all levels of Clinical Data Analysts assigned to the studies to ensure completion of study tasks in a timely manner with quality
• Assist with data listing review, query management activities at key milestones such as interim analysis, lock, safety reviews etc. as needed
• 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 SOC 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 preferably at a CRO or pharma company
• Excellent organizational and project management skills
• Able to take lead and work independently to complete all OM activities
• Highly effective communication skills, both written and verbal
• Technical skills includinq: EDC systems (Medidata Rave and/or iMedNet preferred), , 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

• Bachelor's degree and a minimum of five (5) years of experience in clinical data management, , or an equivalent combination of relevant education and/or experience with current Certified Clinical Data Manager (CCDM).