Opening for Clinical Data Manager II @ Clinipace Worldwide - Trivandrum, India
Job description
The Clinical Data Manager II is responsible for leading the clinical data management process for individual clinical trials. This position assists with the co-ordination and development of clinical databases including processing of case report form and electronic data in accordance with Clinipace Worldwide SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements. The Clinical Data Manager II is responsible for the co-ordination of a group of staff working on a clinical database project.
Locations preferred: Trivandrum, India (Office based)
Job Duties and Responsibilities for the Clinical Data Manager II:
Proactively coordinates and performs start-up, processing and finalisation activities as detailed in our SOPs.
Project budget awareness and proactive management of timelines and projections.
Successfully deliver Data Management deliverables in accordance with internal and external company requirements.
Proactively manages project quality through supervision and Quality Control of team member’s work.
Participation in reviewing and responding to QA audit reports.
Proactive participation in appropriate sponsor/project team meetings.
Where assigned the Lead CDM role acts as key data management contact for the project.
Lead and/or participate in User Acceptance Testing for projects as needed.
Active involvement in departmental and organisational meetings and initiatives.
Assist with development and documentation of departmental procedures.
Participates in the review of cross functional department procedures.
Training and Mentoring of team members in accordance with established departmental procedures.
Proactively coordinates and performs start-up, processing and finalization activities as detailed in our SOPs.
Lead study setup including design, database structure, document creation including approvals.
Communicate with cross functional groups throughout the project lifecycle.
Monitor project scope.
Supervisory Responsibilities: No supervisory responsibilities.
Job Requirements for the Clinical Data Manager II:
Education
College graduate with a life science, computing or nursing qualifications preferred, or 3 to 4 years equivalent experience
Experience
Minimum of 5 years of experience and or demonstrated aptitude for data management work.
Experience working in CRO industry preferred
Working knowledge of EDC studies
Experience working in a home office environment, as applicable.
License/Certification
N/A
Skills/Competencies
Excellent organizational skills
Strong written and verbal communication skills
Exceptional attention to detail
Technology proficiency including Data Management Systems
Study documentation production and maintenance, data processing, data review
Knowledge of clinical research including regulatory requirements GCP/ICH
Data Quality
Strong interpersonal skills
Strong computer skills, including Microsoft Office
Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
Good problem-solving skills
Capabilities
Dedicated home office environment for field based employees.
Work evening and/or weekends on occasion as needed by the project
Conduct internal and externals team meetings as necessary
Provide training to site personnel in person or via electronic meetings
Team player – effective proactive participant as a team member and team leader.
CLINIPACE WILL NOT BE ACCEPTING UNSOLICITED RESUMES FROM THIRD PARTY VENDORS.
Click here to apply
Job description
The Clinical Data Manager II is responsible for leading the clinical data management process for individual clinical trials. This position assists with the co-ordination and development of clinical databases including processing of case report form and electronic data in accordance with Clinipace Worldwide SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements. The Clinical Data Manager II is responsible for the co-ordination of a group of staff working on a clinical database project.
Locations preferred: Trivandrum, India (Office based)
Job Duties and Responsibilities for the Clinical Data Manager II:
Proactively coordinates and performs start-up, processing and finalisation activities as detailed in our SOPs.
Project budget awareness and proactive management of timelines and projections.
Successfully deliver Data Management deliverables in accordance with internal and external company requirements.
Proactively manages project quality through supervision and Quality Control of team member’s work.
Participation in reviewing and responding to QA audit reports.
Proactive participation in appropriate sponsor/project team meetings.
Where assigned the Lead CDM role acts as key data management contact for the project.
Lead and/or participate in User Acceptance Testing for projects as needed.
Active involvement in departmental and organisational meetings and initiatives.
Assist with development and documentation of departmental procedures.
Participates in the review of cross functional department procedures.
Training and Mentoring of team members in accordance with established departmental procedures.
Proactively coordinates and performs start-up, processing and finalization activities as detailed in our SOPs.
Lead study setup including design, database structure, document creation including approvals.
Communicate with cross functional groups throughout the project lifecycle.
Monitor project scope.
Supervisory Responsibilities: No supervisory responsibilities.
Job Requirements for the Clinical Data Manager II:
Education
College graduate with a life science, computing or nursing qualifications preferred, or 3 to 4 years equivalent experience
Experience
Minimum of 5 years of experience and or demonstrated aptitude for data management work.
Experience working in CRO industry preferred
Working knowledge of EDC studies
Experience working in a home office environment, as applicable.
License/Certification
N/A
Skills/Competencies
Excellent organizational skills
Strong written and verbal communication skills
Exceptional attention to detail
Technology proficiency including Data Management Systems
Study documentation production and maintenance, data processing, data review
Knowledge of clinical research including regulatory requirements GCP/ICH
Data Quality
Strong interpersonal skills
Strong computer skills, including Microsoft Office
Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
Good problem-solving skills
Capabilities
Dedicated home office environment for field based employees.
Work evening and/or weekends on occasion as needed by the project
Conduct internal and externals team meetings as necessary
Provide training to site personnel in person or via electronic meetings
Team player – effective proactive participant as a team member and team leader.
CLINIPACE WILL NOT BE ACCEPTING UNSOLICITED RESUMES FROM THIRD PARTY VENDORS.
Click here to apply
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