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Location : Mumbai, Maharashtra
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Job Description : Lead/Responsible for data validation (cleaning/review/reconciliation) activities
during conduct and database lock (Primary CDA), e.g. query management, manual/SAS listing reviews and external vendor data reconciliation.
Highlight issues/risks to delivery by understanding interdependencies – support mitigations as part of Risk Management Plan.
Lead/perform user acceptance testing on clinical database setups.
Review protocols and EDC Entry Screens if required.
Provide input on the data management timelines and coordinate the DM operational activities during database set up.
Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
Perform/Lead functional QC activities on databases and/or patient data, as
per business needs.
Track and review CRFs. Support data entry where required.
QualificationsAbility to lead and collaborate with global teams – ability to coordinate & prioritize tasks for the DM operational team when in the Primary CDA role.Ability to independently interact with Sponsor liaison to discuss data issues/project data validation requirements, as needed.Negotiation skills and ability to influence in order to achieve mutually beneficial results.Strong problem-solving skills and logical reasoning, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses.Commitment to first time quality, including a methodical, analytical and accurate approach to work activities (attention to detail).Time management and prioritization skills with a sense of urgency – in order to meet objectives.Strong interpersonal, oral and written communication skills – using concise phrasing tailored for the audience with a diplomatic approach

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By Richard