Senior Clinical Data Analyst

3 weeks ago

Bloemfontein, South Africa Parexel Full time

We have several roles open at both Senior CDA and CDA II Levels within our South African Data Management team

Senior Clinical Data Analyst:-

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.

Clinical Data Analyst II:-

The Clinical Data Analyst II (CDA II) performs all clinical data validation activities on assigned projects, commensurate with experience and/or project role with minimal guidance and supervision from Line Manager and/or Subject Matter Expert. Further responsibilities shall include support on data validation activities, Data Management documents and data cleaning matrices e.g. Data Validation Specification, CRF Completion Guidelines, Protocol Deviation Specification, Mock Shells for Off-line listing etc.
All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
CDA II may act as a mentor for ACDA or other CDA peers and also as a process lead on a specific data validation activity.

Senior CDA Essential Requirements:

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.

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.

Education:-

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

• Certification or involvement in a professional society or organization is recommended.

Clinical Data Analyst II Essential Requirements:

Knowledge and Experience:-

• Strong technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills).

• Good 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

• Good knowledge of Clinical Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs, ClinBase.)

• Good understanding of Clinical Study Team roles within Data Management

• Experience in clinical research industry

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

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

• Good 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)

Skills:-

• Strong problem-solving skills and logical reasoning

• Commitment to first time quality, including a methodical, analytical and accurate approach to work activities (attention to detail)

• Time management and prioritization skills in order to meet objectives and timelines

• Evidence of ability to work collaboratively within a team environment

• Ability to coordinate & prioritize tasks for the team when in the Primary CDA role.

• Good interpersonal, oral and written communication skills

• 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

• Evidence of accountability relative to Key Accountabilities in Job Description

• Written and oral fluency in English

Education:

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

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