Clinical Data Manager III

Sigma Chi Consulting Pvt. Ltd.; India; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Sigma Chi Consulting Pvt. Ltd. is seeking a Clinical Data Manager III to oversee data management activities on assigned projects within an international team. You will design and review CRF, manage data listings, perform data reconciliation, and support database closeout with minimal supervision.

The role requires 5+ years in data management, familiarity with GCP/ICH, and strong communication skills to coordinate with sponsors and study teams.

Qualifications

• Minimum of 5 years of data management experience.
• Experience in pharmaceutical/CRO data management preferred.
• Strong knowledge of GCP/ICH guidelines.

Responsibilities

• Lead data management activities for assigned projects.
• Review CRF design and ensure protocol alignment.
• Coordinate data reconciliation of external data and SAE handling.
• Support database closeout and lock activities.
• Train and mentor junior team members.

Skills

Data management

Attention to detail

Communication skills

Team leadership

Education

Life sciences degree

Bachelor's degree

Tools

EDC systems

MS Office

Job description

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 Caidya 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 Caidya 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.