Clinical Data Manager II Job Vacancy in Clinipace India – Updated today
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Full Details :
Company Name : Clinipace
Location : India
Position :
Job Description : Job Title: Clinical Data Manager II (CDM II)
Job Location: Anywhere in India ( Full time home based)
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, computing or nursing qualification or 3 to 4 years equivalent experience.
Experience
Minimum of 4 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
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The company will not accept unsolicited resumes from third party vendors.
This post is listed Under Technology
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