Senior Clinical Data Analyst

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.

Roles And Responsibilities

• 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. 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.