Caidya activates the full potential of your science through our personalized partnership, global expertise and knowledge sharing. We take pride in building strong relationships and doing what it takes to deliver solutions to drive your portfolio forward. We are fully invested in the outcomes of your trials. Not only do we provide resources and expertise when and how you need them, but we bring and share expertise and knowledge to help you make the best decisions. We deliver a unique level of collaboration and flexibility with a clear focus on activating knowledge and expertise across our teams, without silos – so you get a transparent view of your project, proactive communication, and a team that is invested in your success.
Job Title: Clinical Data Manager II (CDM II)
Job Location: Work from home
Job Overview: The Clinical Data Manager II participates in the clinical data management activities for a project within a data management project team; including processing of case report form (CRF) and electronic data in accordance with Clinipace SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements.
Job Duties and Responsibilities:
The specific job duties of a Clinical Data Manager II may include but are not limited to:
- For specified projects performs start-up activities including:
- Developing data management guidelines and study documentation
- Assists in developing core study documents for data management including DMP, DVP, CRF completion guidelines, and other study documentation as needed
- Review of CRF design against protocol
- Review of database setup
- For specified projects performs some 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 and associated metrics
- Data Entry
- Review and reconciliation of data listings
- Identification of data issues and query generation
- Updating of database with query resolutions (paper studies only)
- 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
- Provide support to deliver DM specifications for CRF counts and associated details for proposal needs.
- Awareness of the CAPA process and provide input for audit responses regarding assigned tasks
- Participate in User Acceptance Testing for assigned projects
- For specified projects performs study finalization activities including:
- Database close-out
- Critical item review and Quality control support as needed, per platform
- Data review and reconciliation
- Quality Control
- Archiving
- 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
- Other duties as assigned
Supervisory Responsibilities: No supervisory responsibilities.
Job Requirements:
- Education: College graduate with a life science, Pharmacy, computing or nursing qualification or 3 to 4 years equivalent experience.
- Experience:
- Minimum of 3 years of experience with demonstrated experience supporting data management work.
- Experience working in pharmaceutical and/or Contract Research Organization (CRO) industry preferred
- Working knowledge of EDC studies
- Skills/Competencies:
- Strong organizational skills
- Strong written and verbal communication skills
- Exceptional attention to detail
- Knowledge of clinical research including regulatory requirements GCP/ICH
- 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
- Dedicated home office environment for home-based employees, as applicable
