Senior Clinical Data Analyst

5 days ago

Bloemfontein, South Africa Parexel Full time

South Africa-Bloemfontein-Remote
South Africa, Remote

**Job ID** R0000031248

**Category** Data Management

**ABOUT THIS ROLE**:
Parexel are currently recruiting for a Senior Clinical Data Analyst in South Africa.

In this role, the Senior Clinical Data Analyst (SCDA) independently performs/leads and/or coordinates all clinical data validation activities on assigned projects, with a 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.

**This will be a fully remote home-based position.**

**Key Accountabilities**:
**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 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**
- 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.

**What we are looking for in this role**

For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart.

**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.
- 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 prior experience in Microsoft Office Products.
- 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 study specific procedures.
- Advanced knowledge of Clinical Data Management Systems (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 & W

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