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:

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

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.

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