Clinical Data Manager II (CDM II)

Caidya; Kolkata District; Remote; INR 900,000 - 1,300,000; Full time

Job summary

Clinipace is seeking a Clinical Data Manager II for a remote India-based role. You will contribute to data management activities for clinical projects, ensuring CRF design, database setup, data entry, and query resolution align with SOPs, GCP/ICH guidelines, and sponsor requirements.

The role involves start-up tasks, study data reconciliation, audit readiness, and collaboration with cross-functional teams to deliver timely data deliverables.

Qualifications

• Minimum 3 years of data management experience in pharma/CRO
• Experience with EDC studies and data reconciliation
• Knowledge of GCP/ICH regulatory requirements and sponsor expectations
• Experience reviewing CRF designs and database setups

Responsibilities

• Participate in data management activities per SOPs and ICH guidelines.
• Perform data entry, data listing review, and query resolution.
• Manage start-up activities including DM plan, DVP, CRF completion guidelines.
• Support study close-out, archiving, and QA checks.
• Assist in budget tracking and process improvements across DM activities.

Skills

Data management

EDC experience

GCP/ICH knowledge

Documentation & SOPs

Problem solving

Regulatory awareness

Team collaboration

Education

College degree in life sciences, computing or nursing

Tools

Microsoft Office

CDMS / EDC software

Job description

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:

Start-Up Activities

• 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

Study Finalization Activities

• 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 3 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.

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