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Overview

The Clinical Data Manageris responsible formanaging the data management activities for multiple clinical trials.Will work closely with internal team members and vendors to ensure that assigned clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and expectations, and budget. Located in New Haven, CT.

Responsibilities

• Initiate CRF development for new clinical trials and protocol amendments; collaborate with internal team and responsible vendor on CRF development, database design and edit specifications. Ensure established clinical data standards are followed.
• Review CRO Data Management Plans, Data Review Plans and other applicable data management documents for completeness and accuracy.
• Create internal Data Review Plans for review/approval by study team members.
• Create Data Transfer Plans for external data vendors for review/approval by study team members; perform external data reconciliations as applicable.
• Coordinate the internal data review process; perform data review periodically for quality issues and general data trends and communicate to team and/or CRO; oversee and track the ongoing delivery of clean patients by the CRO per established timelines.
• Oversee CRO data management counterparts for assigned clinical trials and ensure that the data management objectives are met in accordance with current SOPs, WPDs and timelines and budget.
• Review Protocols as requested and provide feedback taking CRF design into consideration.
• Review Statistical Analysis Plans and statistical outputs taking CRF/database into consideration.
• Review/contribute to Data Management WPDs and instruction documents.

Qualifications

• Excellent oral and written communications
• Knowledge of and demonstrated experience with clinical data standards is preferred.
• Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact.
• Excellent organizational and priority management skills
• Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook
• Ability to work within established timelines, in a fast-paced environment.
• Knowledge of and experience with EDC for clinical data capture. Experience with Medidata Rave is preferred.
• Ability to work with minimal supervision while communicating to manager issues related to quality, timelines, and budget.
• BS/BA degree in science or similar area
• 3 - 5 years of prior experience managing clinical trials for or within the biotech or pharmaceutical industry, including CRO/vendor management, and knowledge of basic data management processes
• Preferred experience with dermatology/allergy
• In-depth knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required