Job Description
Job Title: Principal Clinical Data Manager
Location: India (Remote)
Job Overview:
The Principal Clinical Data Manager is responsible for leading the Data Management activities for a project/portfolio of studies including timeline, budget, quality management, client relationship and the facilitation of their projects within the data management team. This includes the coordination of data management activities with key project team members performing all associated activities, in accordance with Caidya SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements.
Job Duties and Responsibilities:
The specific job duties of a Principal Clinical Data Manager may include but are not limited to:
- Lead all activities for complex global clinical trials
- Coordinate the work of global staff assigned to the project
- Provide training on procedures and systems
- Create project-related materials
- Track project progress and issue status reports
- Develop and maintain communication with colleagues in other departments
- Ensure the achievement of key milestones relating to the function, such as completion of tasks towards final database
- Attend sponsor related meetings
- Participate in business development meetings
- Serve as the principal function specialist for the department for assigned projects
- Assist in the creation and documentation of new or revised departmental procedures and guidelines
- Supports and tracks budget adherence in cooperation with Finance to ensure the assigned studies are meeting targeted margins and utilization
- Contributes to the departmental strategy and goals, working closely with the DM Lead team to ensure alignment with overall Corporate strategy and goals
- Continuous process 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
- May participate in interviewing potential new department team members
- May participate in or lead process improvement initiatives
- May indirectly supervise others, as needed
- The Principal Clinical Data Manager serves as a leader in project team activities.
- 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 equivalent combination of education and experience.
Experience
- 10 + years practical clinical trials experience
- Minimum of 10 years of experience and/or demonstrated aptitude for data management work and managerial skills
- Global team leadership skills
- Experience working in the Contract Research Organization (CRO) industry (pharma industry tenure could be considered)
- Expertise in clinical development lifecycle and interdependencies of data management
- Expert knowledge of EDC studies and ancillary data
- Cross functional meeting attendance and leadership
Skills/Competencies
- Excellent organizational skills
- Strong written and verbal communication skills
- Exceptional attention to detail
- Knowledge of clinical research including regulatory requirements GCP/ICH
- Proficiency in industry standard data management systems (e.g., RAVE, Medrio, etc.)
- Strong interpersonal skills; serve as the primary company liaison for data management issues
- Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
- Decision making, planning and delegation skills
- Mature management skills demonstrated by calm and thorough review of situations
Capabilities
- Flexibility - willing to change assignments and work focus to accommodate project demands
- Data driven, evidence based work ethic leveraging tools, reports and other knowledge information sources to drive efficiency in data management activities
- 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 and international travel may be required.
