Senior Clinical Data Analyst

What this Senior Clinical Data Analyst Role entails:

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.

Experience & Knowledge you will require to qualify for this role:

1. Advanced technical aptitude with awareness/potential prior experience in Microsoft Office Products (strong computer skills).
2. Advanced understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock).
3. Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures.
4. Advanced knowledge of Clinical Data Management Systems and proficiency in at least one system (e.g. InForm, Rave, Veeva, DataLabs, ClinBase).
5. Good understanding of Clinical Study Team roles within Data Management - awareness of DML activities e.g.: budget reviews, resource forecast, etc.
6. Experience in clinical research industry.
7. Advanced knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG).
8. Advanced knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out.
9. Advanced knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation.
10. Basic knowledge of SAS (programmed listings).
11. Basic knowledge of Data standards (CDISC).
12. Good understanding of financial principles/drivers for management of DM project financials with regards to forecasting and scope of work.
13. Proven experience of leading virtual/global Data Management operational team/s to perform DB set up, data cleaning activities.

Education Requirements for this role:

1. Bachelor’s degree and/or other medical qualifications or relevant industry experience.
2. Certification or involvement in a professional society or organization is recommended.

Skills Required:

1. 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.
2. Ability to independently interact with Sponsor liaison to discuss data issues/project data validation requirements, as needed.
3. Proven negotiation skills and ability to influence in order to achieve mutually beneficial results.
4. Strong problem-solving skills and logical reasoning, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses.
5. Commitment to first time quality, including a methodical, analytical and accurate approach to work activities (attention to detail).
6. Proven Time management and prioritization skills with a strong sense of urgency - in order to meet objectives.
7. Advanced interpersonal, oral and written communication skills - using concise phrasing tailored for the audience with a diplomatic approach.
8. Good presentation skills.
9. Proven learning ability and knowledge sharing approach; swift understanding of technologies and new processes.
10. A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing technical environments.
11. Strong sense of accountability relative to Key Accountabilities in Job Description.
12. Innovative - ability to define strategies to improve efficiency when performing the Data Management tasks.
13. Written and oral fluency in English.

Day-to-Day / Key Accountabilities of this Role:

Data Validation (cleaning)

1. 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.
2. Highlight issues/risks to delivery by understanding interdependencies - support mitigations as part of Risk Management Plan.

Data Management Documents/Plans (Trial Master File)

1. 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)

1. Lead/perform user acceptance testing on clinical database setups.
2. Review protocols and EDC Entry Screens if required.
3. 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

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

Project Quality Management & Compliance

1. Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
2. Perform/Lead functional QC activities on databases and/or patient data, as per business needs.

Training

1. Maintain training compliance as per Job Roles assigned, including On-the-Job training.
2. Address training needs, as per Development Goal/s identified.
3. Provide relevant on-the-job training to staff and project teams as appropriate.
4. Act as Mentor for other clinical data analysts.
5. Act as Subject Matter Expert regarding DM operational tasks/tools/ processes/ systems.

Process/Project Improvement

1. 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

1. 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.