Clinical Data Manager

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 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 four (4) years of experience in clinical data management, , or an equivalent combination of relevant education and/or experience with current Certified Clinical Data Manager (CCDM).

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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