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 3 to 4 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
