NOVARTIS Senior
Clinical Data Manager University or
college Degree in life science, computer science, Pharmacy, Nursing or
equivalent
Your
responsibilities include, but are not limited to:
• Provide
professional DM input as required on in-house and outsourced trials to relevant
stakeholders. Participate in Clinical Trial Team/Data Review Team meetings as
applicable. Input to and review of clinical trial database design including
User Acceptance Testing (UAT).
• Responsible
for the Validation and Analysis Plan (VAP) meeting for the clinical trial,
which includes chairing the meeting, writing the study specific validation
checks and necessary reports to ensure high quality and consistent data. Drive
the same with data collection providers, as needed.
• Identify
errors and inconsistencies; resolve them or initiate their resolution either
via the field monitor or directly with the investigational site/data review
team, to ensure high quality and timely database locks. Review and contribute
to preparation of protocols as required to support stakeholders, specifically
related to the data management section, visit schema, study design and
standards.
• Responsible
for preparation of Case Report Forms (CRFs) and CRF completion Guidelines
(CCGs), electronic or paper. Drive the same with data collection providers, as
needed.
• For studies
which have central data monitoring, CDME(central data monitoring ex-pert) will
be responsible for all oversight of the data including DM deliverables. Will
drive necessary actions as needed and ensure proper integration of central data
monitoring requirements. Support and provide leadership for data management
staff for allocated trials.
• Freeze and
lock data as appropriate in time for statistical review, blinded interim
quality review, interim and final database lock. Drive the same with data
collection providers, as required.
• Perform
training on data management software and practices or trial specific topics as
required. Prepare training materials for data management activities and
processes as required. Travel if required as needed.
Minimum
requirements
• University
or college degree in life science, computer science, pharmacy, nursing or
equivalent relevant degree with 5 or more years’ experience in drug development
with at least 3 years’ experience in Data Management.
• Excellent
written and oral English skills. Good communication and interpersonal skills
•
Understanding of clinical trial methodology, GCP and medical terminology
• Good
organizational and project management skills.
•
Intermediate presentation and problem solving skills
• Ability to
work well in a team. May coordinate and provide direction on task to other data
management team members
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