Senior Clinical Data Analyst

When our values align, there’s no limit to what we can achieve.
 
At Parexel, we all share the same goal – to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special – a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.

Job Purpose:

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.

Key Accountabilities:

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.

Education:

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

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