Drug Safety Associate (Pharmacovigilance)

Job Overview

The Clinical Data Manager III is responsible to participate the clinical data management activities for a project within a data management team; including processing of Case Report form and electronic data, processing and reconciliation of external data, SAE reconciliation and supporting the database close/lock procedures in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements. Work as a Project Point of Contact (POC), manage work allocation and work with minimal or no supervision.

Job Duties And Responsibilities

The specific job duties of a Clinical Data Manager III may include but are not limited to:

• For specified projects performs start-up activities including:
• Developing data management guidelines and study documentation
• Review of CRF design against protocol
• Lead study developing core study documents for data management including DMP, DVP, CRF completion guidelines, and other study documentation. Activities include design, database structure, document creation; including approval
• For specified projects performs data management activities as detailed below and performs activities in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study documentation.
• Study status tracking
• Review of data listings
• Identification of data issues and query generation
• Updating of database with query resolutions (paper studies only)
• Processing and reconciliation of external data including SAE reconciliation
• Ownership and proactive management of the data reconciliation activities documented in the DVP, DMP, etc.
• Provide input for Database closeout and lock activities and timelines
• Archiving of critical documents on an ongoing basis
• If assigned the Lead Data Manager role, act as key data management contact for the project.
• Awareness of the CAPA process and provide input for audit responses regarding assigned tasks
• Proactively manage project quality through supervision and quality control of team members’ work.
• Proactive participation in appropriate sponsor/project team meetings.
• Active involvement in departmental and organizational meetings and initiatives.
• Develops and documents departmental procedures.
• Training and Mentoring of team members in accordance with established departmental procedures.
• Supports and tracks budget adherence in cooperation with Finance to ensure the assigned studies are meeting targeted margins and utilization.
• Continuous improvement of departmental processes and procedures to ensure DM is consistently maximizing efficiencies, leveraging technology and incorporating innovation to optimize delivery.
• Maintains working knowledge of regulatory requirements/guidance as well as industry leading best practices to ensure our DM procedures are in line with industry expectations.
• Indirect supervision of the work of junior members of the project team.
• Other duties as assigned.

Supervisory Responsibilities

No supervisory responsibilities.

Job Requirements

• Education
• College graduate with a degree in life science, computing or nursing qualifications preferred; or 3 to 4 years equivalent experience.
• Experience
• Minimum of 5 years of experience and/or demonstrated aptitude for data management work. International team experience preferred.
• Experience working in pharmaceutical and/or Contract Research Organization (CRO) industry preferred
• Prior trial responsibility for entire data management life-cycle
• Working knowledge of EDC studies
• Skills/Competencies
• Excellent organizational skills
• Strong written and verbal communication skills
• Exceptional attention to detail
• Knowledge of clinical research including regulatory requirements GCP/ICH
• Strong interpersonal skills; serve as the point of contact for data management activities
• Strong computer skills, including Microsoft Office and clinical data management systems
• Demonstrated problem-solving skills
• Capabilities
• Flexibility – willing to change assignments and work focus to accommodate project demands
• Team player – effective proactive participant as a team member.