Senior Clinical Data Manager

Caidya; India; Hybrid; INR 1,800,000 - 2,400,000; Full time

Job summary

Clinipace is seeking a Senior Clinical Data Manager. This role supports data management activities with leadership over DM deliverables in a home/office based setting.

Responsibilities include study setup, project coordination, QA participation, and budget/schedule stewardship, with cross-functional collaboration across the project lifecycle. The ideal candidate brings 7+ years in data management, familiarity with EDC and CDMS, and strong communication and organizational skills to ensure

Qualifications

• Minimum of 7 years of data management experience.
• Experience in pharma/CRO industry is preferred.
• Home office experience is a plus.

Responsibilities

• Lead data management deliverables and DM team on studies.
• Coordinate start-up, maintenance and close-out activities.
• Lead study setup including CRF design and DVP.
• Communicate with cross-functional groups throughout the project.
• Manage project scope, budgets and timelines.
• Ensure quality control of team members' work.
• Assist in QA audits and sponsor meetings.
• Provide training to site personnel.
• Support budget adherence with Finance.

Skills

Communication skills

Organizational skills

Team collaboration

Problem solving

Attention to detail

Microsoft Office

CDM systems

Education

Life science degree

Tools

EDC systems

Microsoft Office

Job description

Home/Office Based Either: Home or Office Based

Job Duties and Responsibilities:

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

• 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
• 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.