Bengaluru, Karnataka, India
Additional Locations Hyderabad, Telangana, India; Mumbai, Maharashtra, India; SAS Nagar (Mohali), Punjab, India
The Senior Clinical Data Analyst (SCDA) independently performs/lead and/or coordinate all clinical data validation activities on assigned projects, commensurate with experience and/or project role, with high degree of proficiency and autonomy. Further responsibilities shall include providing technical expertise and/or operational leadership regarding all DM operational activities (data cleaning matrices), processes and Data Management documents regarding data validation. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements. SCDA acts as a subject matter expert on DM Systems/processes, providing technical support and expert advice to internal and external sponsors. The SCDA may act as a back-up to or fulfill the Data Management Lead role where required.
Skills:
- Proven ability to lead and collaborate with global and cross-functional teams – ability to coordinate & prioritize tasks for the DM operational and programming teams (when) in the Primary CDA role.
- Ability to independently interact with Sponsor liaison to discuss data issues/project data validation requirements, as needed.
- Proven 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).
- Proven Time management and prioritization skills with a strong sense of urgency – in order to meet objectives.
Knowledge and Experience:
- Advanced technical aptitude with awareness/potential prior experience in Microsoft Office Products (strong computer skills).
- Advanced understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock).
- Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements and company SOPs and study specific procedures.
Apply here: https://jobs.parexel.com/en/job/bengaluru/senior-clinical-data-analyst/877/66796102272