Job Description

Job Title: Clinical Data Manager II (CDM II)

Job Location: India (Remote)

Job Overview:

The Clinical Data Manager II participates in the clinical data management activities for a project within a data management project team; including processing of case report form (CRF) and electronic data in accordance with Clinipace SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements.

Job Duties and Responsibilities:

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

For specified projects performs start-up activities including:

• Developing data management guidelines and study documentation
• Assists in developing core study documents for data management including DMP, DVP, CRF completion guidelines, and other study documentation as needed
• Review of CRF design against protocol
• Review of database setup

For specified projects performs some 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 and associated metrics
• Data Entry
• Review and reconciliation of data listings
• Identification of data issues and query generation
• Updating of database with query resolutions (paper studies only)
• 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

Provide support to deliver DM specifications for CRF counts and associated details for proposal needs.

Awareness of the CAPA process and provide input for audit responses regarding assigned tasks

Participate in User Acceptance Testing for assigned projects

For specified projects performs study finalization activities including:

• Database close-out
• Critical item review and Quality control support as needed, per platform
• Data review and reconciliation
• Quality Control
• Archiving

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 Clinipace DM procedures are in line with industry expectations

Other duties as assigned

Supervisory Responsibilities:

No supervisory responsibilities.

Job Requirements:

Education

• College graduate with a life science, computing or nursing qualification or 3 to 4 years equivalent experience.

Experience

• Minimum of 2 years of experience with demonstrated experience supporting data management work.
• Experience working in pharmaceutical and/or Contract Research Organization (CRO) industry preferred
• Working knowledge of EDC studies

Skills/Competencies:

• Strong organizational skills
• Strong written and verbal communication skills
• Exceptional attention to detail
• Knowledge of clinical research including regulatory requirements GCP/ICH
• 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
• Dedicated home office environment for home-based employees, as applicable.

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The company will not accept unsolicited resumes from third party vendors.