The Senior Clinical Data Analyst (8+ years exp.) 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.

Accountability

Data Validation(cleaning)

• 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

Data Management Documents/Plans(Trial Master File)

• Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines.

Study Start-Up Activities and User Acceptance Testing(UAT)

• 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.

Data Tracking and Entry

• Track and review CRFs. Support data entry where required.

Project Quality Management & Compliance

• Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.

• Perform/Lead functional QC activities on databases and/or patient data, as per business needs.

Training

• Maintain training compliance as per Job Roles assigned, including On-the-Job training.

• Address training needs, as per Development Goal/s identified.

• Provide relevant on-the-job training to staff and project teams as appropriate

• Act as Mentor for other clinical data analysts.

• Act as Subject Matter Expert regarding DM operational tasks/tools/ processes/systems.

Process/Project Improvement

• Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies.

Project Finance & Resource Support

• Determine root cause of operations-related project variance in a timely manner, based on DM operational metrics/labor hour reports - provide input on Changes in Scope needed.

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.

• Advanced interpersonal, oral and written communication skills - using concise phrasing tailored for the audience with a diplomatic approach.

• Good presentation skills.

• Proven learning ability and knowledge sharing approach; swift understanding of technologies and new processes.

• A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing technical environments.

• Strong sense of accountability relative to Key Accountabilities in Job Description.

• Innovative - ability to define strategies to improve efficiency when performing the Data Management tasks.

• Written and oral fluency in English

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 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.)

• Good understanding of Clinical Study Team roles within Data Management - awareness of DML activities e.g.: budget reviews, resource forecast, etc.

• Experience in clinical research industry.

• Advanced knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG).

• Advanced knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out.

• Advanced knowledge of Database set-up activities, including but not limited to Database

• Configuration Specifications and setup of Data Validation.

• Basic knowledge of SAS (programmed listings).

• Basic knowledge of Data standards (CDISC).

• Good understanding of financial principles/drivers for management of DM project financials with regards to forecasting and scope of work.

• Proven experience of leading virtual/global Data Management operational team/s to perform DB set up, data cleaning activities.

“Experience from CRO industry is desirable”

Location: Hybrid- Bengaluru/Hyderabad/Mumbai/Mohali

Education:

Bachelor’s degree and/or other medical qualifications and relevant industry experience.