Senior Clinical Data Manager

Caidya; Kolkata District; Remote; INR 1,800,000 - 3,000,000; Full time

Job summary

Caidya is seeking a Senior Clinical Data Manager to lead data management activities on complex clinical studies conducted remotely in India. The role requires oversight of DM deliverables, CRF design, DVP development, data validation and QA, while coordinating with cross-functional teams and sponsors to maintain timelines and study budgets.

The ideal candidate has 7+ years in clinical data management, experience with EDC systems, and strong regulatory knowledge (GCP/ICH).

Qualifications

• 7+ years of data management experience in pharma/CRO settings.
• Experience with full data management lifecycle in clinical trials.
• Home office availability if applicable.

Responsibilities

• Lead DM deliverables on the project, oversee DM team and client communications.
• Provide DM deliverables per sponsor/company requirements.
• Coordinate start-up, maintenance and close-out activities per SOPs.

Skills

Data management

Project leadership

Regulatory compliance

Communication

Problem solving

Education

Life science degree

Nursing

Computing degree

Tools

EDC software

MS Office

Job description

Job Title: Senior Clinical Data Manager

Job Location - India (Remote)

Job Overview

The Senior Clinical Data Manager is responsible for leading the clinical data management activities for a project including CRF design, database development, processing external data, medical coding, data review, SAE reconciliation and database close/lock procedures in accordance with Caidya SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements. Responsible for leading Data Management activities for a project including timeline, budget, quality management, client relationship and the facilitation of their projects within the data management team.

Job Duties and Responsibilities

• Perform Lead Data Manager role on the study teams assigned; oversee the DM deliverables for the project including leading the DM team, communications with the client, ensuring adherence to timelines and budget responsibility (maintain identified margins)
• Provide Data Management deliverables in accordance with internal and external company requirements
• Proactively coordinate and perform start-up, maintenance and close out activities, as detailed in our SOPs, guidelines, templates and best practice documents
• Lead study setup including CRF design, DVP, CCGs, DMP and all associated DM deliverables; including approvals
• Communicate with cross functional groups throughout the project lifecycle
• Proactively manage project scope and budgets, including time spent on data management tasks, and associated timelines and projections
• Proactively manage project quality via coordination and quality control of team members’ work
• Participation in reviewing and responding to QA audit reports
• Proactive participation in appropriate sponsor/project team meetings
• Provide training to site personnel in person or via electronic meetings
• Active involvement in departmental and organizational meetings and initiatives
• Participates in the review of cross-functional department procedures
• Training and Mentoring of team members in accordance with established departmental procedures
• Represent Clinipace at client meetings and bid defenses
• 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
• May indirectly supervise the work of other 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 required or 6 to 8 years equivalent experience.

Experience

• Minimum of 7 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 and ancillary data
• Experience working in a home office environment, as applicable

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 primary company liaison for data management issues
• Strong computer skills, including Microsoft Office and clinical data management systems
• Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
• Superior 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 and team leader.
• Dedicated home office environment for home-based employees, as applicable.
• Travel: Some local travel may be required.