Job Description

Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com

No 3 rd party agencies

Responsibilities:

• Ensure accurate and efficient logging and tracking procedures for CRFs, DRFs, DAFs and all other patient documentation retrieved from study sites
• Design the workflow for the timely flow of study data through the processes of data entry, data review, coding, SAE reconciliation, external data loads, data query and data resolution, and final database lock activities
• Provide input from the data management perspective regarding the design of clinical trial protocols and case report forms
• Coordinate with Sponsor and Vendors to ensure efficiency and quality of the setup procedures for the receipt and incorporation of internal and external data files
• Develop and maintain all aspects of data guidelines across all functions within data management
• Creation and testing of data review and validation guidelines (DVG)
• Ensure database and annotated CRF are setup in accordance with study contract and SOPs
• Create study specific data management plan (DMP)
• Examine study data for legibility, scientific accuracy, completeness, and study integrity
• Issue queries to study sites when missing, incorrect, or inconsistent data are identified through the data review procedures
• Integrate data from all sources to ensure data and case report forms are accurate and complete
• Perform coding of adverse events, medical conditions and medications
• Perform the reconciliation of serious adverse event and device reconciliation
• Organize the filing and storage of case report forms and working copies
• Coordinate CDM, CDA, and DES tasks as required
• Ensure tasks contracted are completed according to statements of work
• Assist with the identification and preparation of changes to statements of work
• Assist with sales and marketing initiatives
• Maintain a clinical data management notebook for each clinical trial documenting the data management course of each study, and generate summary activity reports as required
• Participate in departmental process improvements
• Provide constructive feedback to team members
• Enhance and create departmental standard operating procedures, standard documents, and templates

Requirements:

• BS, BA, BSN in a scientific, or health related field is required (Masters is preferred but not essential)
• Minimum of 6 years of experience in clinical trials
• Minimum of 6 years of direct data management experience
• Preferred experience in oncology 
• Knowledge of medical terminology and pharmaceutical notation is required
• Knowledge of medical terminology and pharmaceutical notation
• Expertise with EDC systems, such as Medidata Rave, InForm, Medrio
• Excellent organizational and time management skills
• Strong collaboration and leadership skills

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