Parexel Hiring for Senior Clinical Data Analyst Job at Hyderābād Full Time

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.

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.
Lead/perform user acceptance testing on clinical database setups.
Review protocols and EDC Entry Screens if required.
Provide input on and tracking the data management timelines and coordinate the DM operational activities during database set up, up to project close out.

Qualifications

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.
• Advanced interpersonal, oral and written communication skills – using concise phrasing tailored for the audience with a diplomatic approach.
• 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 PAREXEL SOPs and study specific procedures.
• Advanced knowledge of Clinical Data Management Systems and proficiency in at least one system (e.g. InForm, Rave, Veeva, DataLabs, ClinBase.)