Clinipace Life Science CDM Job Opening – Applications Invited
Clinipace Life Science CDM Job Opening – Applications Invited. MSc Life Science Job Openings. Life Science Job Opening. MSc Jobs. Interested and eligible applicants can check out all of the details on the same below:
Job Title: Clinical Data Manager II
Job Location: Thiruvananthapuram, Kerala, India
Job Description:
The Clinical Data Manager II participates in the clinical data management activities for a project within a data management project team; including the processing of case report form (CRF) as well as electronic data according to Clinipace SOPs, Good Clinical Practice, ICH Guidelines as well as sponsor requirements.
Job Duties and also Responsibilities:
For specified projects performs start-up activities including:
- Developing data management guidelines and also study documentation.
- Review of CRF design against protocol.
- Review of database setup.
- For specified projects performs some data management activities as detailed below and also performs activities based on our SOPs, Good Clinical Practice, ICH Guidelines and study documentation.
- Study status tracking.
- Data Entry.
- Review of data listings.
- Identification of data issues and also query generation.
- Updating of the database with query resolutions (paper studies only).
- Archiving of critical documents on an ongoing basis.
- Participate in User Acceptance Testing for assigned projects.
- For specified projects performs study finalization activities including:.
- Database close-out.
- Critical item review.
- Quality Control.
- Archiving
Job Requirements:
Education
- College graduate/postgraduate with a life science qualification favoured.
Experience:
- Minimum of 3.6 years of experience and/or demonstrated an aptitude for data management work.
- Experience working in a pharmaceutical and/or Contract Research Organization (CRO) industry.
- Working knowledge of EDC studies.
Skills/Competencies:
- Good organizational skills.
- Strong written as well as verbal communication skills.
- Exceptional attention to detail.
- Knowledge of clinical research including regulatory requirements GCP/ICH.
- Strong computer skills, including Microsoft Office and also clinical data management systems.
- Excellent problem-solving skills.
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